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| Name | Class |
|---|---|
| University of Washington | OTHER |
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This partnership between Talkspace and the University of Washington (UW) ALACRITY Center will determine how effective unlimited text-based psychotherapy for depression is when compared to once-a-week psychotherapy. This study will also determine what the best treatment options are for people who are not responding well to either unlimited texting or weekly psychotherapy. The results of this study will be a new product version of message-based care that can tailor psychotherapy intensity based on the needs of future consumers with depression.
This is a fast track Small Business Innovation Research (SBIR) proposal that will (1) test the effectiveness of daily, message-based psychotherapy (MBP) for depression, compared to traditionally delivered, video-chat psychotherapy (VCP) and (2) develop an evidence-based treatment sequence for those who do not respond to either daily MBP or VCP.
Phase 1 consists of a pilot study to determine the best incentive model to retain a sample of people 18 years old and older with depression into a SMART trial. Information from this pilot will inform the retention strategy for Phase 2.
Phase 2 is a 12-week, randomized clinical trial using a SMART design to test the following aims: 1. Determine the relative effectiveness of daily MBP compared to weekly VCP in treating symptoms of depression and improving social functioning; 2. For those who fail to respond to 6 weeks of weekly VCP only, determine whether the addition of daily messaging, or a switch to monthly video-chat plus daily messaging improves depression and functional outcomes; and 3. For those who fail to respond to 6 weeks of daily MBP, whether the addition of monthly video-chat or weekly video-chat improves outcomes. Participants will provide data on mood, activity, and functioning, and we will collect data on use of treatment (texts and sessions), and working alliance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 2: Message-Based Psychotherapy (MBP; Level 1 and Level 2) | Experimental | Phase 2 participants who respond to Message-Based Psychotherapy (MBP; Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2). |
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| Phase 2: Video-Chat Psychotherapy (VCP; Level 1 and Level 2) | Experimental | Phase 2 participants who respond to Video-Chat Psychotherapy (VCP; Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). VCP consists of weekly psychotherapy appointments that last between 30-45 minutes. |
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| Phase 2: MBP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Experimental | Phase 2: This arm includes participants in MBP (Level 1) who do not respond to treatment by week 5. The Premium Plan intervention consists of MBP with monthly VCP (Level 2). The Premium Plan allows patients unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5. |
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| Phase 2: MBP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Experimental | Phase 2: This arm includes participants in MBP (Level 1) who do not respond to treatment by week 5. The Ultimate Plan intervention consists of MBP with weekly VCP (Level 2). The Ultimate Plan allows patients unlimited MBP and weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video-Chat Psychotherapy (VCP) | Behavioral | Video-Chat Psychotherapy (VCP) consists of weekly psychotherapy appointments that last between 30-45 minutes. These sessions are conducted using Agora, a secure, HIPAA-compliant video conferencing service that is seamlessly integrated into the Talkspace platform application. Therapists will provide evidence-based treatments for depression and anxiety. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neuro-QOL - Ability to Participate in Social Roles and Activities | Neuro-Quality of Life v1.0 (Neuro-QOL). The Neuro-QOL Ability to Participate in Social Roles and Activities short form item bank is an 8-item patient-rated measure of social functioning. Items focus on difficulty participating in social, family, and work activities, and are rated on a 1 to 5 scale for a total score between 8 and 40. Neuro-QOL scores were transformed into t-scores per the scoring manual; after transformation, total scores range from 24.1 to 60.2. Transformed scores are reported. Higher scores indicate less difficulty participating in social roles and activities. The Neuro-QOL was not distributed in Phase 1. | Change from Baseline Neuro-QOL at 6 weeks and 12 weeks after treatment starts |
| Change in Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire-9 (PHQ-9) consists of 9 depression items and one disability item. Each time is associated with a Diagnostic and Statistical Manual (DMS) symptom of depression, which the participant rates whether or not they have experienced the symptom over the last two weeks, with severity rating of 0-3. It is one of the few measures that is brief (it takes less than one minute to give) and has been found to have excellent sensitivity to change over time. Total scores range from 0-27, with higher scores indicating greater severity of depression. | Change from Baseline PHQ-9 at 6 weeks and 12 weeks after treatment starts |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Generalized Anxiety Disorder (GAD-7) | To assess for co-occurring anxiety, we will use the Generalized Anxiety Disorder-7 (GAD-7), a 7- item screener for generalized anxiety disorder (GAD). Participants rate on a scale of 0-3 how much they have experienced symptoms of GAD in the last two weeks. Total scores range from 0 to 21, with higher scores indicating greater severity of anxiety. The scale is a valid screener for GAD. |
| Measure | Description | Time Frame |
|---|---|---|
| Expectations About Treatment: Treatment Rationale Scale (TRS) | Expectations about treatment can influence outcomes. To assess participant expectations, we will administer the Treatment Rationale Scale (TRS), a 4-item scale administered before the 2nd and last session. The scale assesses patient expectations about the success of treatment. Items are rated on a scale of 0 (not at all) to 10 (very). Total scores range from 0 to 40, with higher scores indicating better outcomes. 1) How logical does your Talkspace treatment seem to you? 2) How confident are you that the treatment will be successful in eliminating your depression? 3) How confident would you be in recommending the treatment to a friend with depression? 4) If you were extremely depressed, would you be willing to undergo such treatment? |
Inclusion and exclusion criteria are the same for Phase 1 and Phase 2.
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Talkspace | New York | New York | 10025 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41165707 | Derived | Pullmann MD, Rouvere J, Raue PJ, Griffith Fillipo IR, Mosser BA, Heagerty PJ, Fridling-Cook N, Padmanabhan A, Hull TD, Arean PA. Message-Based vs Video-Based Psychotherapy for Depression: A Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2540065. doi: 10.1001/jamanetworkopen.2025.40065. | |
| 34728440 | Derived |
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Quantitative data is available upon reasonable request with a fully executed Data Use Agreement with Talkspace.
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The Participant Flow below shows arms by combination of Level 1 and Level 2 conditions. Sample sizes from baseline to week 5 apply to Level 1 conditions. Sample sizes from week 6 to week 12 apply to Level 2 conditions. Therefore, sample sizes for arms including Level 2 conditions from baseline to week 5 are 0.
Baseline to Week 5: "Participated in the Intervention" includes the analytic sample for Level 1 analyses. "Completed" is defined as participants evaluated for Level 2 randomization.
Week 6 to Week 12: Phase 1 "Completed" is defined as having completed the PHQ-9 at any time between weeks 6 to 12. Phase 2 "Completed" is defined as having completed outcome measures between weeks 6 to 12.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 2: Message-Based Psychotherapy (MBP; Level 1 and Level 2) | Phase 2 participants who respond to Message-Based Psychotherapy (MBP; Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2). |
| FG001 | Phase 2: Video-Chat Psychotherapy (VCP; Level 1 and Level 2) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline to Week 5 - Level 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 16, 2025 |
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Phase 1 will test the effectiveness of two forms of participant retention methods into a SMART (sequential, multiple assignment, randomized). In Phase 1, participants (n=200) will be randomized to an incentive level and then randomized to treatment arms. Phase 2 (n=1000) will be the subsequent SMART design comparing message-based psychotherapy (MBP) to video-chat psychotherapy (VCP) in level 1 and for those who do not respond to care after 6 weeks, those participants will be randomized to either MBP+monthly VCP or MBP+weekly VCP.
Arms/Interventions have been adjusted to align with the results for the Phase 2 SMART.
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In Phase 1, participants will be masked to the incentive condition to which they are randomized but will be aware of which treatment condition they are receiving.
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| Phase 2: VCP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Experimental | Phase 2: This arm includes participants in VCP (Level 1) who do not respond to treatment by week 5. The Premium Plan intervention consists of MBP with monthly VCP (Level 2). The Premium Plan allows patients unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5. |
|
| Phase 2: VCP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Experimental | Phase 2: This arm includes participants in VCP (Level 1) who do not respond to treatment by week 5. The Ultimate Plan intervention consists of MBP with weekly VCP (Level 2). The Ultimate Plan allows patients unlimited MBP and weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5. |
|
| Phase 1: High Monetary Incentive (HMI) + VCP (Level 1 and Level 2) | Experimental | Phase 1 participants who respond to VCP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. |
|
| Phase 1: High Monetary Incentive (HMI) + MBP (Level 1 and Level 2) | Experimental | Phase 1 participants who respond to MBP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2). Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. |
|
| Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1 and Level 2) | Experimental | Phase 1 participants who respond to VCP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. |
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| Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1 and Level 2) | Experimental | Phase 1 participants who respond to MBP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2). Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. |
|
| Phase 1: HMI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Experimental | Phase 1: This arm includes participants in HMI + VCP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
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| Phase 1: HMI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2) | Experimental | Phase 1: This arm includes participants in HMI + VCP (Level 1) who do not respond to treatment by week 5. The Switch Arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
|
| Phase 1: HMI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Experimental | Phase 1: This arm includes participants in HMI + MBP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
|
| Phase 1: HMI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2) | Experimental | Phase 1: This arm includes participants in HMI + MBP (Level 1) who do not respond to treatment by week 5. The Minimal Augmentation arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
|
| Phase 1: LMAI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Experimental | Phase 1: This arm includes participants in LMAI + VCP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
|
| Phase 1: LMAI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2) | Experimental | Phase 1: This arm includes participants in LMAI + VCP (Level 1) who do not respond to treatment by week 5. The Switch Arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
|
| Phase 1: LMAI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Experimental | Phase 1: This arm includes participants in LMAI + MBP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
|
| Phase 1: LMAI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2) | Experimental | Phase 1: This arm includes participants in LMAI + MBP (Level 1) who do not respond to treatment by week 5. The Minimal Augmentation arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
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|
| Message-Based Psychotherapy (MBP) | Behavioral | Message-Based Psychotherapy (MBP) allows patients to chat with an assigned licensed therapist as frequently as they wish. After consumers complete an intake and select a therapist, the consumer can begin chatting with their therapist right away, and as often as they wish. Therapists respond to text within 15 minutes to an hour during office hours, and within 14 hours outside of office hours. Thus, MBP is not fully synchronous. This enables therapists to deliver care to a larger number of patients than is possible under synchronous methods by disentangling the therapist's time from the patient's time to respond. It also has the potential to improve quality as it gives the therapist time to think through the most effective response and intervention. MBP will be based on CBT, PST or IPT intervention strategies. |
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| Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy | Behavioral | Message-Based Psychotherapy (MBP) with monthly Video-Chat Psychotherapy (VCP) allows patients unlimited texting with their therapist and once a month, 30-45 minute video chat with the same therapist. Therapist and participants schedule their video chat appointment to occur at once a month interval during therapist office hours. The content of these sessions, as well as the MBP portion of care, will be based on CBT, PST or IPT. In Phase 1, this is referred to as "Switch Arm" (for participants assigned to VCP at baseline) or "Minimal Augmentation" (for participants assigned to MBP at baseline). In Phase 2, this is referred to as the "Premium Plan". |
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| Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy | Behavioral | Message-Based Psychotherapy (MBP) with weekly Video-Chat Psychotherapy (VCP) allows patients access to both unlimited MBP, but will be able to schedule weekly, 30-45 minute video chat with the same therapist. Therapists will provide care based on CBT, PST or IPT. In Phase 1, this is referred to as the "Augmentation Arm". In Phase 2, this is referred to as the "Ultimate Plan." |
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| High Monetary Incentive (HMI) | Behavioral | Participants in the traditional, high monetary incentive arm will receive a total of $125 for completing 12 weeks of assessments. |
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| Low Monetary and Alternative Incentive (LMAI) | Behavioral | Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. |
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| Change from Baseline GAD-7 at 6 weeks and 12 weeks after treatment starts |
| Week 1 |
| Experience of Care and Health Outcomes Survey (ECHO) | The Experience of Care and Health Outcomes Survey (ECHO) items assess whether consumers received timely treatment, enough information to support self-management, and were involved in treatment as much as they wanted. ECHO is a reliable instrument with alpha = .85. For quality of care, participants rated an adapted version of item 28 of the Consumer Assessment of Healthcare Providers and Systems (CAHPS) ECHO survey: "In the past 4 weeks, using any number from 0 to 10, where 0 is the worst mental health care possible and 10 is the best mental health care possible, what number would you use to rate the mental health care you received from Talkspace?" Ratings range from 0 to 10. Higher scores indicate better quality of care received. | 10 weeks after treatment starts |
| Working Alliance Inventory-Short Revised (WAI-SR) | Participants rated therapeutic alliance using the Working Alliance Inventory-Short Revised (WAI-SR), a 12-item measure of therapeutic alliance (relationship between the consumer and therapist or coach) evaluating three domains: goals, tasks, and bond. Items are rated on a scale from 1 to 5. Total scores range from 12-60, with higher scores indicating a more effective therapeutic relationship. It is a reliable measure of alliance, with alpha = .92. | 10 weeks after treatment starts |
| Tailoring Variable - Response to Treatment | To determine whether patients move to Level 2 treatment (starting at week 6), we will used clinician administered Patient Health Questionnaire-9 (PHQ-9) between weeks 3 to 5 of treatment. Response to treatment was defined as a PHQ-9 score less than 50% of the participant's baseline PHQ-9 score. Response to treatment was also evaluated via therapist feedback. Participants who responded to their Level 1 treatment assignment continued in that condition from weeks 6 to 12. Participants who did not respond to treatment were switched to either MBP with weekly VCP or to MBP with monthly VCP. | 6 weeks after treatment starts |
| Treatment Use Variables: Number of Sessions Attended | Phase 1: Number of distinct days of messaging plus number of live video sessions attended Phase 2: Number of sessions attended, defined as the number of sessions during which the client sent any messages or attended any video sessions, regardless of Level 1 condition (e.g., includes sessions during which participants in VCP only sent messages). | 12 weeks after treatment starts |
| Treatment Use Variables: Number of Messages Sent | Number of messages sent, regardless of condition (e.g., also includes number of messages sent by clients in VCP only). | 12 weeks after treatment starts |
| Treatment Use Variables: Time Between Patient and Psychotherapist Contact | Time between patient and psychotherapist contact, defined as the number of days from client's Level 1 randomization date to the date of first psychotherapist message or video call. These data were available only for Phase 2. | 12 weeks after treatment starts |
| Arean P, Hull D, Pullmann MD, Heagerty PJ. Protocol for a sequential, multiple assignment, randomised trial to test the effectiveness of message-based psychotherapy for depression compared with telepsychotherapy. BMJ Open. 2021 Nov 2;11(11):e046958. doi: 10.1136/bmjopen-2020-046958. |
Phase 2 participants who respond to Video-Chat Psychotherapy (VCP; Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). VCP consists of weekly psychotherapy appointments that last between 30-45 minutes. |
| FG002 | Phase 2: MBP (Level 1) to Preimum Plan (MBP with monthly VCP; Level 2) | Phase 2: This arm includes participants in MBP (Level 1) who do not respond to treatment by week 5. The Premium Plan intervention consists of MBP with monthly VCP (Level 2). The Premium Plan allows patients unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5. |
| FG003 | Phase 2: MBP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Phase 2: This arm includes participants in MBP (Level 1) who do not respond to treatment by week 5. The Ultimate Plan intervention consists of MBP with weekly VCP (Level 2). The Ultimate Plan allows patients unlimited MBP and weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5. |
| FG004 | Phase 2: VCP (Level 1) to Preimum Plan (MBP with monthly VCP; Level 2) | Phase 2: This arm includes participants in VCP (Level 1) who do not respond to treatment by week 5. The Premium Plan intervention consists of MBP with monthly VCP (Level 2). The Premium Plan allows patients unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5. |
| FG005 | Phase 2: VCP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Phase 2: This arm includes participants in VCP (Level 1) who do not respond to treatment by week 5. The Ultimate Plan intervention consists of MBP with weekly VCP (Level 2). The Ultimate Plan allows patients unlimited MBP and weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5. |
| FG006 | Phase 1: High Monetary Incentive (HMI) + VCP (Level 1 and Level 2) | Phase 1 participants who respond to VCP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. |
| FG007 | Phase 1: High Monetary Incentive (HMI) + MBP (Level 1 and Level 2) | Phase 1 participants who respond to MBP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2). Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. |
| FG008 | Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1 and Level 2) | Phase 1 participants who respond to VCP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. |
| FG009 | Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1 and Level 2) | Phase 1 participants who respond to MBP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2). Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. |
| FG010 | Phase 1: HMI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Phase 1: This arm includes participants in HMI + VCP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| FG011 | Phase 1: HMI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2) | Phase 1: This arm includes participants in HMI + VCP (Level 1) who do not respond to treatment by week 5. The Switch Arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| FG012 | Phase 1: HMI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Phase 1: This arm includes participants in HMI + MBP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| FG013 | Phase 1: HMI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2) | Phase 1: This arm includes participants in HMI + MBP (Level 1) who do not respond to treatment by week 5. The Minimal Augmentation arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| FG014 | Phase 1: LMAI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Phase 1: This arm includes participants in LMAI + VCP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| FG015 | Phase 1: LMAI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2) | Phase 1: This arm includes participants in LMAI + VCP (Level 1) who do not respond to treatment by week 5. The Switch Arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| FG016 | Phase 1: LMAI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Phase 1: This arm includes participants in LMAI + MBP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| FG017 | Phase 1: LMAI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2) | Phase 1: This arm includes participants in LMAI + MBP (Level 1) who do not respond to treatment by week 5. The Minimal Augmentation arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| Participated in the Intervention |
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| COMPLETED | Evaluated for Level 2 randomization |
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| NOT COMPLETED |
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| Week 6 to Week 12 - Level 2 |
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All participants randomized to a Level 1 condition who participated in the intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 2: Message-Based Psychotherapy (MBP; Level 1) | Message-Based Psychotherapy (MBP) allows patients to chat with an assigned licensed therapist as frequently as they wish. After consumers complete an intake and select a therapist, the consumer can begin chatting with their therapist right away, and as often as they wish. Therapists respond to text within 15 minutes to an hour during office hours, and within 14 hours outside of office hours. Thus, MBP is not fully synchronous. This enables therapists to deliver care to a larger number of patients than is possible under synchronous methods by disentangling the therapist's time from the patient's time to respond. It also has the potential to improve quality as it gives the therapist time to think through the most effective response and intervention. MBP will be based on CBT, PST or IPT intervention strategies. |
| BG001 | Phase 2: Video-Chat Psychotherapy (VCP; Level 1) | Video-Chat Psychotherapy (VCP) consists of weekly psychotherapy appointments that last between 30-45 minutes. These sessions are conducted using Agora, a secure, HIPAA-compliant video conferencing service that is seamlessly integrated into the Talkspace platform application. Therapists will provide evidence-based treatments for depression and anxiety. |
| BG002 | Phase 1: High Monetary Incentive (HMI) + VCP (Level 1) | Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. Video-Chat Psychotherapy (VCP) consists of weekly psychotherapy appointments that last between 30-45 minutes. These sessions are conducted using Agora, a secure, HIPAA-compliant video conferencing service that is seamlessly integrated into the Talkspace platform application. Therapists will provide evidence-based treatments for depression and anxiety. |
| BG003 | Phase 1: High Monetary Incentive (HMI) + MBP (Level 1) | Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. Message-Based Psychotherapy (MBP) allows patients to chat with an assigned licensed therapist as frequently as they wish. After consumers complete an intake and select a therapist, the consumer can begin chatting with their therapist right away, and as often as they wish. Therapists respond to text within 15 minutes to an hour during office hours, and within 14 hours outside of office hours. Thus, MBP is not fully synchronous. This enables therapists to deliver care to a larger number of patients than is possible under synchronous methods by disentangling the therapist's time from the patient's time to respond. It also has the potential to improve quality as it gives the therapist time to think through the most effective response and intervention. MBP will be based on CBT, PST or IPT intervention strategies. |
| BG004 | Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1) | Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. Video-Chat Psychotherapy (VCP) consists of weekly psychotherapy appointments that last between 30-45 minutes. These sessions are conducted using Agora, a secure, HIPAA-compliant video conferencing service that is seamlessly integrated into the Talkspace platform application. Therapists will provide evidence-based treatments for depression and anxiety. |
| BG005 | Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1) | Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. Message-Based Psychotherapy (MBP) allows patients to chat with an assigned licensed therapist as frequently as they wish. After consumers complete an intake and select a therapist, the consumer can begin chatting with their therapist right away, and as often as they wish. Therapists respond to text within 15 minutes to an hour during office hours, and within 14 hours outside of office hours. Thus, MBP is not fully synchronous. This enables therapists to deliver care to a larger number of patients than is possible under synchronous methods by disentangling the therapist's time from the patient's time to respond. It also has the potential to improve quality as it gives the therapist time to think through the most effective response and intervention. MBP will be based on CBT, PST or IPT intervention strategies. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
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| Age, Continuous | Includes participants who participated in the intervention. | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Patient Health Questionnaire-9 (PHQ-9) | The Patient Health Questionnaire-9 (PHQ-9) consists of 9 depression items and one disability item. Each time is associated with a Diagnostic and Statistical Manual (DMS) symptom of depression, which the participant rates whether or not they have experienced the symptom over the last two weeks, with severity rating of 0-3. It is one of the few measures that is brief (it takes less than one minute to give) and has been found to have excellent sensitivity to change over time. Total scores range from 0-27, with higher scores indicating greater severity of depression. | Includes participants who provided data at baseline. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Neuro-QOL - Ability to Participate in Social Roles and Activities | Neuro-Quality of Life v1.0 (Neuro-QOL). The Neuro-QOL Ability to Participate in Social Roles and Activities short form item bank is an 8-item patient-rated measure of social functioning. Items focus on difficulty participating in social, family, and work activities, and are rated on a 1 to 5 scale for a total score between 8 and 40. Neuro-QOL scores were transformed into t-scores per the scoring manual; after transformation, total scores range from 24.1 to 60.2. Transformed scores are reported. Higher scores indicate less difficulty participating in social roles and activities. The Neuro-QOL was not distributed in Phase 1. | Phase 2 participants contributing data at baseline, week 6, or week 12. Overall number of participants analyzed includes total number of participants who contributed data at any relevant timepoint. | Posted | Mean | Standard Deviation | T-score | Change from Baseline Neuro-QOL at 6 weeks and 12 weeks after treatment starts |
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| Primary | Change in Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire-9 (PHQ-9) consists of 9 depression items and one disability item. Each time is associated with a Diagnostic and Statistical Manual (DMS) symptom of depression, which the participant rates whether or not they have experienced the symptom over the last two weeks, with severity rating of 0-3. It is one of the few measures that is brief (it takes less than one minute to give) and has been found to have excellent sensitivity to change over time. Total scores range from 0-27, with higher scores indicating greater severity of depression. | All participants randomized to a Level 2 condition contributing data at baseline, week 6, or week 12. Overall number of participants analyzed includes total number of participants who contributed data at any relevant timepoint. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline PHQ-9 at 6 weeks and 12 weeks after treatment starts |
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| Secondary | Change in Generalized Anxiety Disorder (GAD-7) | To assess for co-occurring anxiety, we will use the Generalized Anxiety Disorder-7 (GAD-7), a 7- item screener for generalized anxiety disorder (GAD). Participants rate on a scale of 0-3 how much they have experienced symptoms of GAD in the last two weeks. Total scores range from 0 to 21, with higher scores indicating greater severity of anxiety. The scale is a valid screener for GAD. | All participants contributing data at baseline, week 6, or week 12. Overall number of participants analyzed includes total number of participants who contributed data at any relevant timepoint. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline GAD-7 at 6 weeks and 12 weeks after treatment starts |
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| Other Pre-specified | Expectations About Treatment: Treatment Rationale Scale (TRS) | Expectations about treatment can influence outcomes. To assess participant expectations, we will administer the Treatment Rationale Scale (TRS), a 4-item scale administered before the 2nd and last session. The scale assesses patient expectations about the success of treatment. Items are rated on a scale of 0 (not at all) to 10 (very). Total scores range from 0 to 40, with higher scores indicating better outcomes. 1) How logical does your Talkspace treatment seem to you? 2) How confident are you that the treatment will be successful in eliminating your depression? 3) How confident would you be in recommending the treatment to a friend with depression? 4) If you were extremely depressed, would you be willing to undergo such treatment? | Participants providing data on all items of the Treatment Rationale Scale at week 1. | Posted | Mean | Standard Deviation | units on a scale | Week 1 |
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| Other Pre-specified | Experience of Care and Health Outcomes Survey (ECHO) | The Experience of Care and Health Outcomes Survey (ECHO) items assess whether consumers received timely treatment, enough information to support self-management, and were involved in treatment as much as they wanted. ECHO is a reliable instrument with alpha = .85. For quality of care, participants rated an adapted version of item 28 of the Consumer Assessment of Healthcare Providers and Systems (CAHPS) ECHO survey: "In the past 4 weeks, using any number from 0 to 10, where 0 is the worst mental health care possible and 10 is the best mental health care possible, what number would you use to rate the mental health care you received from Talkspace?" Ratings range from 0 to 10. Higher scores indicate better quality of care received. | Participants randomized to a Level 2 condition contributing data at week 10. | Posted | Mean | Standard Deviation | units on a scale | 10 weeks after treatment starts |
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| Other Pre-specified | Working Alliance Inventory-Short Revised (WAI-SR) | Participants rated therapeutic alliance using the Working Alliance Inventory-Short Revised (WAI-SR), a 12-item measure of therapeutic alliance (relationship between the consumer and therapist or coach) evaluating three domains: goals, tasks, and bond. Items are rated on a scale from 1 to 5. Total scores range from 12-60, with higher scores indicating a more effective therapeutic relationship. It is a reliable measure of alliance, with alpha = .92. | Participants randomized to a Level 2 condition contributing data at week 10. | Posted | Mean | Standard Deviation | units on a scale | 10 weeks after treatment starts |
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| Other Pre-specified | Tailoring Variable - Response to Treatment | To determine whether patients move to Level 2 treatment (starting at week 6), we will used clinician administered Patient Health Questionnaire-9 (PHQ-9) between weeks 3 to 5 of treatment. Response to treatment was defined as a PHQ-9 score less than 50% of the participant's baseline PHQ-9 score. Response to treatment was also evaluated via therapist feedback. Participants who responded to their Level 1 treatment assignment continued in that condition from weeks 6 to 12. Participants who did not respond to treatment were switched to either MBP with weekly VCP or to MBP with monthly VCP. | Includes participants assessed for Level 2 randomization. | Posted | Count of Participants | Participants | 6 weeks after treatment starts |
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| Other Pre-specified | Treatment Use Variables: Number of Sessions Attended | Phase 1: Number of distinct days of messaging plus number of live video sessions attended Phase 2: Number of sessions attended, defined as the number of sessions during which the client sent any messages or attended any video sessions, regardless of Level 1 condition (e.g., includes sessions during which participants in VCP only sent messages). | Includes participants who sent any number of messages or attended any number of video sessions. | Posted | Mean | Standard Deviation | sessions | 12 weeks after treatment starts |
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| Other Pre-specified | Treatment Use Variables: Number of Messages Sent | Number of messages sent, regardless of condition (e.g., also includes number of messages sent by clients in VCP only). | Includes participants who sent any number of messages; excludes participants who sent no messages. | Posted | Mean | Standard Deviation | number of messages | 12 weeks after treatment starts |
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| Other Pre-specified | Treatment Use Variables: Time Between Patient and Psychotherapist Contact | Time between patient and psychotherapist contact, defined as the number of days from client's Level 1 randomization date to the date of first psychotherapist message or video call. These data were available only for Phase 2. | Phase 2 participants who received a message from a psychotherapist or attended a video session. | Posted | Mean | Standard Deviation | days | 12 weeks after treatment starts |
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Phase 1: Adverse event data were collected through study completion, an average of 5 months. Phase 2: Adverse event data were collected through study completion, an average of 2 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 2: Message-Based Psychotherapy (MBP; Level 1 and Level 2) | Phase 2 participants who respond to Message-Based Psychotherapy (MBP; Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2). | 0 | 485 | 0 | 485 | 0 | 485 |
| EG001 | Phase 2: Video-Chat Psychotherapy (VCP; Level 1 and Level 2) | Phase 2 participants who respond to Video-Chat Psychotherapy (VCP; Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). VCP consists of weekly psychotherapy appointments that last between 30-45 minutes. | 0 | 484 | 1 | 484 | 0 | 484 |
| EG002 | Phase 2: MBP (Level 1) to Preimum Plan (MBP With Monthly VCP; Level 2) | Phase 2: This arm includes participants in MBP (Level 1) who do not respond to treatment by week 5. The Premium Plan intervention consists of MBP with monthly VCP (Level 2). The Premium Plan allows patients unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5. | 0 | 114 | 0 | 114 | 0 | 114 |
| EG003 | Phase 2: MBP (Level 1) to Ultimate Plan (MBP With Weekly VCP; Level 2) | Phase 2: This arm includes participants in MBP (Level 1) who do not respond to treatment by week 5. The Ultimate Plan intervention consists of MBP with weekly VCP (Level 2). The Ultimate Plan allows patients unlimited MBP and weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5. | 0 | 144 | 0 | 144 | 0 | 144 |
| EG004 | Phase 2: VCP (Level 1) to Preimum Plan (MBP With Monthly VCP; Level 2) | Phase 2: This arm includes participants in VCP (Level 1) who do not respond to treatment by week 5. The Premium Plan intervention consists of MBP with monthly VCP (Level 2). The Premium Plan allows patients unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5. | 0 | 126 | 0 | 126 | 0 | 126 |
| EG005 | Phase 2: VCP (Level 1) to Ultimate Plan (MBP With Weekly VCP; Level 2) | Phase 2: This arm includes participants in VCP (Level 1) who do not respond to treatment by week 5. The Ultimate Plan intervention consists of MBP with weekly VCP (Level 2). The Ultimate Plan allows patients unlimited MBP and weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5. | 0 | 117 | 0 | 117 | 0 | 117 |
| EG006 | Phase 1: High Monetary Incentive (HMI) + VCP (Level 1 and Level 2) | Phase 1 participants who respond to VCP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. | 0 | 55 | 0 | 55 | 0 | 55 |
| EG007 | Phase 1: High Monetary Incentive (HMI) + MBP (Level 1 and Level 2) | Phase 1 participants who respond to MBP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2). Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. | 0 | 54 | 1 | 54 | 0 | 54 |
| EG008 | Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1 and Level 2) | Phase 1 participants who respond to VCP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. | 0 | 52 | 0 | 52 | 0 | 52 |
| EG009 | Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1 and Level 2) | Phase 1 participants who respond to MBP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2). Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. | 0 | 54 | 0 | 54 | 0 | 54 |
| EG010 | Phase 1: HMI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Phase 1: This arm includes participants in HMI + VCP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG011 | Phase 1: HMI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2) | Phase 1: This arm includes participants in HMI + VCP (Level 1) who do not respond to treatment by week 5. The Switch Arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG012 | Phase 1: HMI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Phase 1: This arm includes participants in HMI + MBP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG013 | Phase 1: HMI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2) | Phase 1: This arm includes participants in HMI + MBP (Level 1) who do not respond to treatment by week 5. The Minimal Augmentation arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG014 | Phase 1: LMAI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Phase 1: This arm includes participants in LMAI + VCP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG015 | Phase 1: LMAI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2) | Phase 1: This arm includes participants in LMAI + VCP (Level 1) who do not respond to treatment by week 5. The Switch Arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG016 | Phase 1: LMAI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Phase 1: This arm includes participants in LMAI + MBP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG017 | Phase 1: LMAI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2) | Phase 1: This arm includes participants in LMAI + MBP (Level 1) who do not respond to treatment by week 5. The Minimal Augmentation arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. | 0 | 16 | 0 | 16 | 0 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Psychiatric disorders | Non-systematic Assessment | Participant self-admitted themselves for inpatient, psychiatric care (Phase 1: n=1, HMI+MBP [Level 1]; Phase 2: n=1, VCP [Level 1]) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aarthi Padmanabhan | Talkspace | 240-273-6191 | aarthi.padmanabhan@talkspace.com |
| Sep 9, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 11, 2023 | May 2, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Week 6 |
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| Week 12 |
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| Mean Difference (Final Values) |
| 0.7 |
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| Superiority |
| OG002 | Phase 2: MBP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Phase 2: This arm includes participants in MBP (Level 1) who do not respond to treatment by week 5. The Premium Plan intervention consists of MBP with monthly VCP (Level 2). The Premium Plan allows patients unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG003 | Phase 2: MBP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Phase 2: This arm includes participants in MBP (Level 1) who do not respond to treatment by week 5. The Ultimate Plan intervention consists of MBP with weekly VCP (Level 2). The Ultimate Plan allows patients unlimited MBP and weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG004 | Phase 2: VCP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Phase 2: This arm includes participants in VCP (Level 1) who do not respond to treatment by week 5. The Premium Plan intervention consists of MBP with monthly VCP (Level 2). The Premium Plan allows patients unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG005 | Phase 2: VCP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Phase 2: This arm includes participants in VCP (Level 1) who do not respond to treatment by week 5. The Ultimate Plan intervention consists of MBP with weekly VCP (Level 2). The Ultimate Plan allows patients unlimited MBP and weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG006 | Phase 1: High Monetary Incentive (HMI) + VCP (Level 1 and Level 2) | Phase 1 participants who respond to VCP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. |
| OG007 | Phase 1: High Monetary Incentive (HMI) + MBP (Level 1 and Level 2) | Phase 1 participants who respond to MBP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2). Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. |
| OG008 | Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1 and Level 2) | Phase 1 participants who respond to VCP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. |
| OG009 | Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1 and Level 2) | Phase 1 participants who respond to MBP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2). Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. |
| OG010 | Phase 1: HMI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Phase 1: This arm includes participants in HMI + VCP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG011 | Phase 1: HMI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2) | Phase 1: This arm includes participants in HMI + VCP (Level 1) who do not respond to treatment by week 5. The Switch Arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG012 | Phase 1: HMI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Phase 1: This arm includes participants in HMI + MBP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG013 | Phase 1: HMI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2) | Phase 1: This arm includes participants in HMI + MBP (Level 1) who do not respond to treatment by week 5. The Minimal Augmentation arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG014 | Phase 1: LMAI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Phase 1: This arm includes participants in LMAI + VCP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG015 | Phase 1: LMAI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2) | Phase 1: This arm includes participants in LMAI + VCP (Level 1) who do not respond to treatment by week 5. The Switch Arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG016 | Phase 1: LMAI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2) | Phase 1: This arm includes participants in LMAI + MBP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG017 | Phase 1: LMAI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2) | Phase 1: This arm includes participants in LMAI + MBP (Level 1) who do not respond to treatment by week 5. The Minimal Augmentation arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
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| OG001 | Phase 2: Video-Chat Psychotherapy (VCP; Level 1) | Video-Chat Psychotherapy (VCP) consists of weekly psychotherapy appointments that last between 30-45 minutes. These sessions are conducted using Agora, a secure, HIPAA-compliant video conferencing service that is seamlessly integrated into the Talkspace platform application. Therapists will provide evidence-based treatments for depression and anxiety. |
| OG002 | Phase 1: High Monetary Incentive (HMI) + VCP (Level 1) | Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. Video-Chat Psychotherapy (VCP) consists of weekly psychotherapy appointments that last between 30-45 minutes. These sessions are conducted using Agora, a secure, HIPAA-compliant video conferencing service that is seamlessly integrated into the Talkspace platform application. Therapists will provide evidence-based treatments for depression and anxiety. |
| OG003 | Phase 1: High Monetary Incentive (HMI) + MBP (Level 1) | Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. Message-Based Psychotherapy (MBP) allows patients to chat with an assigned licensed therapist as frequently as they wish. After consumers complete an intake and select a therapist, the consumer can begin chatting with their therapist right away, and as often as they wish. Therapists respond to text within 15 minutes to an hour during office hours, and within 14 hours outside of office hours. Thus, MBP is not fully synchronous. This enables therapists to deliver care to a larger number of patients than is possible under synchronous methods by disentangling the therapist's time from the patient's time to respond. It also has the potential to improve quality as it gives the therapist time to think through the most effective response and intervention. MBP will be based on CBT, PST or IPT intervention strategies. |
| OG004 | Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1) | Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. Video-Chat Psychotherapy (VCP) consists of weekly psychotherapy appointments that last between 30-45 minutes. These sessions are conducted using Agora, a secure, HIPAA-compliant video conferencing service that is seamlessly integrated into the Talkspace platform application. Therapists will provide evidence-based treatments for depression and anxiety. |
| OG005 | Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1) | Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. Message-Based Psychotherapy (MBP) allows patients to chat with an assigned licensed therapist as frequently as they wish. After consumers complete an intake and select a therapist, the consumer can begin chatting with their therapist right away, and as often as they wish. Therapists respond to text within 15 minutes to an hour during office hours, and within 14 hours outside of office hours. Thus, MBP is not fully synchronous. This enables therapists to deliver care to a larger number of patients than is possible under synchronous methods by disentangling the therapist's time from the patient's time to respond. It also has the potential to improve quality as it gives the therapist time to think through the most effective response and intervention. MBP will be based on CBT, PST or IPT intervention strategies. |
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| OG001 | Phase 2: Video-Chat Psychotherapy (VCP; Level 1) | Video-Chat Psychotherapy (VCP) consists of weekly psychotherapy appointments that last between 30-45 minutes. These sessions are conducted using Agora, a secure, HIPAA-compliant video conferencing service that is seamlessly integrated into the Talkspace platform application. Therapists will provide evidence-based treatments for depression and anxiety. |
| OG002 | Phase 1: High Monetary Incentive (HMI) + VCP (Level 1) | Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. Video-Chat Psychotherapy (VCP) consists of weekly psychotherapy appointments that last between 30-45 minutes. These sessions are conducted using Agora, a secure, HIPAA-compliant video conferencing service that is seamlessly integrated into the Talkspace platform application. Therapists will provide evidence-based treatments for depression and anxiety. |
| OG003 | Phase 1: High Monetary Incentive (HMI) + MBP (Level 1) | Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. Message-Based Psychotherapy (MBP) allows patients to chat with an assigned licensed therapist as frequently as they wish. After consumers complete an intake and select a therapist, the consumer can begin chatting with their therapist right away, and as often as they wish. Therapists respond to text within 15 minutes to an hour during office hours, and within 14 hours outside of office hours. Thus, MBP is not fully synchronous. This enables therapists to deliver care to a larger number of patients than is possible under synchronous methods by disentangling the therapist's time from the patient's time to respond. It also has the potential to improve quality as it gives the therapist time to think through the most effective response and intervention. MBP will be based on CBT, PST or IPT intervention strategies. |
| OG004 | Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1) | Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. Video-Chat Psychotherapy (VCP) consists of weekly psychotherapy appointments that last between 30-45 minutes. These sessions are conducted using Agora, a secure, HIPAA-compliant video conferencing service that is seamlessly integrated into the Talkspace platform application. Therapists will provide evidence-based treatments for depression and anxiety. |
| OG005 | Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1) | Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. Message-Based Psychotherapy (MBP) allows patients to chat with an assigned licensed therapist as frequently as they wish. After consumers complete an intake and select a therapist, the consumer can begin chatting with their therapist right away, and as often as they wish. Therapists respond to text within 15 minutes to an hour during office hours, and within 14 hours outside of office hours. Thus, MBP is not fully synchronous. This enables therapists to deliver care to a larger number of patients than is possible under synchronous methods by disentangling the therapist's time from the patient's time to respond. It also has the potential to improve quality as it gives the therapist time to think through the most effective response and intervention. MBP will be based on CBT, PST or IPT intervention strategies. |
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| OG002 | Phase 2: MBP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Phase 2: This arm includes participants in MBP (Level 1) who did not respond to treatment by week 5. The Premium Plan (PP) intervention consists of MBP with monthly VCP (Level 2). The Premium Plan allows patients unlimited texting with their therapist and once a month, 30-45 minute video chat with the same therapist. This Level 2 intervention will serve as one of two augmentation "switch arms" for participants who do not respond to MBP or VCP alone by week 5. |
| OG003 | Phase 2: MBP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Phase 2: This arm includes participants in MBP (Level 1) who did not respond to treatment by week 5. The Ultimate Plan (UP) intervention consists of MBP with weekly VCP (Level 2). Like the Premium Plan, participants in the Ultimate Plan will have access to both unlimited MBP, but will be able to schedule weekly, 30-45 minute video chat with the same therapist. This Level 2 intervention will serve as one of two augmentation "switch arms" for participants who do not respond to MBP or VCP alone by week 5. |
| OG004 | Phase 2: VCP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2) | Phase 2: This arm includes participants in VCP (Level 1) who did not respond to treatment by week 5. The Premium Plan (PP) intervention consists of MBP with monthly VCP (Level 2). The Premium Plan allows patients unlimited texting with their therapist and once a month, 30-45 minute video chat with the same therapist. This Level 2 intervention will serve as one of two augmentation "switch arms" for participants who do not respond to MBP or VCP alone by week 5. |
| OG005 | Phase 2: VCP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2) | Phase 2: This arm includes participants in VCP (Level 1) who did not respond to treatment by week 5. The Ultimate Plan (UP) intervention consists of MBP with weekly VCP (Level 2). Like the Premium Plan, participants in the Ultimate Plan will have access to both unlimited MBP, but will be able to schedule weekly, 30-45 minute video chat with the same therapist. This Level 2 intervention will serve as one of two augmentation "switch arms" for participants who do not respond to MBP or VCP alone by week 5. |
| OG006 | Phase 1: High Monetary Incentive (HMI) + VCP (Level 1 and Level 2) | Phase 1 participants who respond to VCP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. |
| OG007 | Phase 1: High Monetary Incentive (HMI) + MBP (Level 1 and Level 2) | Phase 1 participants who respond to MBP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2). Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. |
| OG008 | Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1 and Level 2) | Phase 1 participants who respond to VCP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. |
| OG009 | Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1 and Level 2) | Phase 1 participants who respond to MBP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2). Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. |
| OG010 | Phase 1: HMI + VCP (Level 1) to Augmentation Arm (MBP With Weekly VCP; Level 2) | Phase 1: This arm includes participants in HMI + VCP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG011 | Phase 1: HMI + VCP (Level 1) to Switch Arm (MBP With Monthly VCP; Level 2) | Phase 1: This arm includes participants in HMI + VCP (Level 1) who do not respond to treatment by week 5. The Switch Arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG012 | Phase 1: HMI + MBP (Level 1) to Augmentation Arm (MBP With Weekly VCP; Level 2) | Phase 1: This arm includes participants in HMI + MBP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG013 | Phase 1: HMI + MBP (Level 1) to Minimal Augmentation (MBP With Monthly VCP; Level 2) | Phase 1: This arm includes participants in HMI + MBP (Level 1) who do not respond to treatment by week 5. The Minimal Augmentation arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG014 | Phase 1: LMAI + VCP (Level 1) to Augmentation Arm (MBP With Weekly VCP; Level 2) | Phase 1: This arm includes participants in LMAI + VCP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG015 | Phase 1: LMAI + VCP (Level 1) to Switch Arm (MBP With Monthly VCP; Level 2) | Phase 1: This arm includes participants in LMAI + VCP (Level 1) who do not respond to treatment by week 5. The Switch Arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG016 | Phase 1: LMAI + MBP (Level 1) to Augmentation Arm (MBP With Weekly VCP; Level 2) | Phase 1: This arm includes participants in LMAI + MBP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG017 | Phase 1: LMAI + MBP (Level 1) to Minimal Augmentation (MBP With Monthly VCP; Level 2) | Phase 1: This arm includes participants in LMAI + MBP (Level 1) who do not respond to treatment by week 5. The Minimal Augmentation arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
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Phase 2: This arm includes participants in MBP (Level 1) who did not respond to treatment by week 5. The Premium Plan (PP) intervention consists of MBP with monthly VCP (Level 2). The Premium Plan allows patients unlimited texting with their therapist and once a month, 30-45 minute video chat with the same therapist. This Level 2 intervention will serve as one of two augmentation "switch arms" for participants who do not respond to MBP or VCP alone by week 5. |
| OG003 | Phase 2: MBP (Level 1) to Ultimate Plan (MBP With Weekly VCP; Level 2) | Phase 2: This arm includes participants in MBP (Level 1) who did not respond to treatment by week 5. The Ultimate Plan (UP) intervention consists of MBP with weekly VCP (Level 2). Like the Premium Plan, participants in the Ultimate Plan will have access to both unlimited MBP, but will be able to schedule weekly, 30-45 minute video chat with the same therapist. This Level 2 intervention will serve as one of two augmentation "switch arms" for participants who do not respond to MBP or VCP alone by week 5. |
| OG004 | Phase 2: VCP (Level 1) to Premium Plan (MBP With Monthly VCP; Level 2) | Phase 2: This arm includes participants in VCP (Level 1) who did not respond to treatment by week 5. The Premium Plan (PP) intervention consists of MBP with monthly VCP (Level 2). The Premium Plan allows patients unlimited texting with their therapist and once a month, 30-45 minute video chat with the same therapist. This Level 2 intervention will serve as one of two augmentation "switch arms" for participants who do not respond to MBP or VCP alone by week 5. |
| OG005 | Phase 2: VCP (Level 1) to Ultimate Plan (MBP With Weekly VCP; Level 2) | Phase 2: This arm includes participants in VCP (Level 1) who did not respond to treatment by week 5. The Ultimate Plan (UP) intervention consists of MBP with weekly VCP (Level 2). Like the Premium Plan, participants in the Ultimate Plan will have access to both unlimited MBP, but will be able to schedule weekly, 30-45 minute video chat with the same therapist. This Level 2 intervention will serve as one of two augmentation "switch arms" for participants who do not respond to MBP or VCP alone by week 5. |
| OG006 | Phase 1: High Monetary Incentive (HMI) + VCP (Level 1 and Level 2) | Phase 1 participants who respond to VCP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. |
| OG007 | Phase 1: High Monetary Incentive (HMI) + MBP (Level 1 and Level 2) | Phase 1 participants who respond to MBP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2). Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. |
| OG008 | Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1 and Level 2) | Phase 1 participants who respond to VCP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. |
| OG009 | Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1 and Level 2) | Phase 1 participants who respond to MBP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2). Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. |
| OG010 | Phase 1: HMI + VCP (Level 1) to Augmentation Arm (MBP With Weekly VCP; Level 2) | Phase 1: This arm includes participants in HMI + VCP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG011 | Phase 1: HMI + VCP (Level 1) to Switch Arm (MBP With Monthly VCP; Level 2) | Phase 1: This arm includes participants in HMI + VCP (Level 1) who do not respond to treatment by week 5. The Switch Arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG012 | Phase 1: HMI + MBP (Level 1) to Augmentation Arm (MBP With Weekly VCP; Level 2) | Phase 1: This arm includes participants in HMI + MBP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG013 | Phase 1: HMI + MBP (Level 1) to Minimal Augmentation (MBP With Monthly VCP; Level 2) | Phase 1: This arm includes participants in HMI + MBP (Level 1) who do not respond to treatment by week 5. The Minimal Augmentation arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG014 | Phase 1: LMAI + VCP (Level 1) to Augmentation Arm (MBP With Weekly VCP; Level 2) | Phase 1: This arm includes participants in LMAI + VCP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG015 | Phase 1: LMAI + VCP (Level 1) to Switch Arm (MBP With Monthly VCP; Level 2) | Phase 1: This arm includes participants in LMAI + VCP (Level 1) who do not respond to treatment by week 5. The Switch Arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG016 | Phase 1: LMAI + MBP (Level 1) to Augmentation Arm (MBP With Weekly VCP; Level 2) | Phase 1: This arm includes participants in LMAI + MBP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
| OG017 | Phase 1: LMAI + MBP (Level 1) to Minimal Augmentation (MBP With Monthly VCP; Level 2) | Phase 1: This arm includes participants in LMAI + MBP (Level 1) who do not respond to treatment by week 5. The Minimal Augmentation arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5. |
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| OG001 | Phase 2: Video-Chat Psychotherapy (VCP; Level 1) | Video-Chat Psychotherapy (VCP) consists of weekly psychotherapy appointments that last between 30-45 minutes. These sessions are conducted using Agora, a secure, HIPAA-compliant video conferencing service that is seamlessly integrated into the Talkspace platform application. Therapists will provide evidence-based treatments for depression and anxiety. |
| OG002 | Phase 1: High Monetary Incentive (HMI) + VCP (Level 1) | Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. Video-Chat Psychotherapy (VCP) consists of weekly psychotherapy appointments that last between 30-45 minutes. These sessions are conducted using Agora, a secure, HIPAA-compliant video conferencing service that is seamlessly integrated into the Talkspace platform application. Therapists will provide evidence-based treatments for depression and anxiety. |
| OG003 | Phase 1: High Monetary Incentive (HMI) + MBP (Level 1) | Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. Message-Based Psychotherapy (MBP) allows patients to chat with an assigned licensed therapist as frequently as they wish. After consumers complete an intake and select a therapist, the consumer can begin chatting with their therapist right away, and as often as they wish. Therapists respond to text within 15 minutes to an hour during office hours, and within 14 hours outside of office hours. Thus, MBP is not fully synchronous. This enables therapists to deliver care to a larger number of patients than is possible under synchronous methods by disentangling the therapist's time from the patient's time to respond. It also has the potential to improve quality as it gives the therapist time to think through the most effective response and intervention. MBP will be based on CBT, PST or IPT intervention strategies. |
| OG004 | Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1) | Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. Video-Chat Psychotherapy (VCP) consists of weekly psychotherapy appointments that last between 30-45 minutes. These sessions are conducted using Agora, a secure, HIPAA-compliant video conferencing service that is seamlessly integrated into the Talkspace platform application. Therapists will provide evidence-based treatments for depression and anxiety. |
| OG005 | Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1) | Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. Message-Based Psychotherapy (MBP) allows patients to chat with an assigned licensed therapist as frequently as they wish. After consumers complete an intake and select a therapist, the consumer can begin chatting with their therapist right away, and as often as they wish. Therapists respond to text within 15 minutes to an hour during office hours, and within 14 hours outside of office hours. Thus, MBP is not fully synchronous. This enables therapists to deliver care to a larger number of patients than is possible under synchronous methods by disentangling the therapist's time from the patient's time to respond. It also has the potential to improve quality as it gives the therapist time to think through the most effective response and intervention. MBP will be based on CBT, PST or IPT intervention strategies. |
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Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. Video-Chat Psychotherapy (VCP) consists of weekly psychotherapy appointments that last between 30-45 minutes. These sessions are conducted using Agora, a secure, HIPAA-compliant video conferencing service that is seamlessly integrated into the Talkspace platform application. Therapists will provide evidence-based treatments for depression and anxiety. |
| OG003 | Phase 1: High Monetary Incentive (HMI) + MBP (Level 1) | Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. Message-Based Psychotherapy (MBP) allows patients to chat with an assigned licensed therapist as frequently as they wish. After consumers complete an intake and select a therapist, the consumer can begin chatting with their therapist right away, and as often as they wish. Therapists respond to text within 15 minutes to an hour during office hours, and within 14 hours outside of office hours. Thus, MBP is not fully synchronous. This enables therapists to deliver care to a larger number of patients than is possible under synchronous methods by disentangling the therapist's time from the patient's time to respond. It also has the potential to improve quality as it gives the therapist time to think through the most effective response and intervention. MBP will be based on CBT, PST or IPT intervention strategies. |
| OG004 | Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1) | Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. Video-Chat Psychotherapy (VCP) consists of weekly psychotherapy appointments that last between 30-45 minutes. These sessions are conducted using Agora, a secure, HIPAA-compliant video conferencing service that is seamlessly integrated into the Talkspace platform application. Therapists will provide evidence-based treatments for depression and anxiety. |
| OG005 | Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1) | Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. Message-Based Psychotherapy (MBP) allows patients to chat with an assigned licensed therapist as frequently as they wish. After consumers complete an intake and select a therapist, the consumer can begin chatting with their therapist right away, and as often as they wish. Therapists respond to text within 15 minutes to an hour during office hours, and within 14 hours outside of office hours. Thus, MBP is not fully synchronous. This enables therapists to deliver care to a larger number of patients than is possible under synchronous methods by disentangling the therapist's time from the patient's time to respond. It also has the potential to improve quality as it gives the therapist time to think through the most effective response and intervention. MBP will be based on CBT, PST or IPT intervention strategies. |
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| OG003 | Phase 1: High Monetary Incentive (HMI) + MBP (Level 1) | Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments. Message-Based Psychotherapy (MBP) allows patients to chat with an assigned licensed therapist as frequently as they wish. After consumers complete an intake and select a therapist, the consumer can begin chatting with their therapist right away, and as often as they wish. Therapists respond to text within 15 minutes to an hour during office hours, and within 14 hours outside of office hours. Thus, MBP is not fully synchronous. This enables therapists to deliver care to a larger number of patients than is possible under synchronous methods by disentangling the therapist's time from the patient's time to respond. It also has the potential to improve quality as it gives the therapist time to think through the most effective response and intervention. MBP will be based on CBT, PST or IPT intervention strategies. |
| OG004 | Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1) | Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. Video-Chat Psychotherapy (VCP) consists of weekly psychotherapy appointments that last between 30-45 minutes. These sessions are conducted using Agora, a secure, HIPAA-compliant video conferencing service that is seamlessly integrated into the Talkspace platform application. Therapists will provide evidence-based treatments for depression and anxiety. |
| OG005 | Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1) | Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate. Message-Based Psychotherapy (MBP) allows patients to chat with an assigned licensed therapist as frequently as they wish. After consumers complete an intake and select a therapist, the consumer can begin chatting with their therapist right away, and as often as they wish. Therapists respond to text within 15 minutes to an hour during office hours, and within 14 hours outside of office hours. Thus, MBP is not fully synchronous. This enables therapists to deliver care to a larger number of patients than is possible under synchronous methods by disentangling the therapist's time from the patient's time to respond. It also has the potential to improve quality as it gives the therapist time to think through the most effective response and intervention. MBP will be based on CBT, PST or IPT intervention strategies. |
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