Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RF1MH128785 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The University of Texas Health Science Center at San Antonio | OTHER |
| Talkspace | INDUSTRY |
| National Institute of Mental Health (NIMH) | NIH |
| University of Pennsylvania |
Not provided
Not provided
Not provided
Not provided
There is a pressing need to increase capacity to treat PTSD related to or exacerbated by the COVID-19 pandemic. Texting-based therapy holds promise to increase capacity and reduce barriers to delivering evidence-based treatments (EBTs), but ongoing engagement in digital mental health interventions is low. This study will compare a texting-based EBT for PTSD to culturally-informed texting-based treatment for PTSD as usual, and it will also compare a unique incentive strategy to typical platform reminders aimed to prevent early discontinuation in therapy. This online study is open to individuals who live in 18 different states.
The COVID-19 pandemic has exacerbated mental health challenges for trauma-exposed individuals due to increased isolation, insufficient capacity in the mental health workforce, and a predicted fourth wave of mental health impacts of the pandemic itself. There is a pressing need to increase treatment capacity. Digital mental health (DMH) interventions for posttraumatic stress disorder (PTSD) address well-documented barriers to traditional in-person psychotherapy or telehealth delivery of evidence-based treatments (EBTs) for PTSD, but many consumers do not remain engaged. Thus, acceptable, efficient, and engaging forms of EBTs are sorely needed, particularly for those who are less likely to access traditional psychotherapy or use online programs. Asynchronous texting therapy platforms may facilitate treatment engagement among those who seek discrete, convenient, and affordable support. In a pilot study of a texting-based format of an EBT for PTSD, Cognitive Processing Therapy (CPT-Text), CPT-Text was feasible to deliver, and clients showed substantially greater PTSD symptom improvement over a shorter time compared to text therapy as usual (TAU). A larger scale, more rigorous test is necessary. This is a randomized, Hybrid Type 1, effectiveness-implementation trial with a factorial design to compare text-based therapies for PTSD utilizing the HIPAA-compliant secure texting platform of our DMH partner, Talkspace. Participants will be enrolled in the study once they have consented, and competed the initial assessment, and determined to meet eligibility requirements. The study team will randomize participants (N= 360) who have PTSD that is related to, has been exacerbated, or developed during the COVID-19 pandemic into CPT-Text or text-based Culturally Informed Trauma Treatment As Usual (CITT). After approximately a week of onboarding with their therapist (e.g., introduction, establishing treatment goals, etc), the active texting intervention will begin and assessments will occur at established timepoints through 24 weeks after the active intervention begins. Active interventions will occur over the course of 12 weeks. Participants will also be randomized into one of two engagement strategies: therapist reminder as usual (RAU) or RAU + incentive (RI). The study will examine an innovative incentive structure in which the study will "pay it forward" by offering free or discounted therapy to other individuals with PTSD when participants remain engaged. The study will compare the impact of an engagement strategy on treatment response and engagement, and will examine motivation as a potential mechanism. The study will also evaluate a novel Natural Language Processing (NLP) or Large-Language Model (LLM) based approach to assessing CPT-Text fidelity. This study will (1) provide critical information about how to promote sustained DMH engagement using unique incentive strategies and moderators of engagement and outcomes and (2) offer first guidance on supporting quality and fidelity of messaging-based EBTs using computational methods.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPT-Text + Incentive | Experimental | CPT-Text. CPT is a 12-session (13 text-based modules), trauma-focused, cognitive therapy that teaches clients to examine and change problematic beliefs about themselves and the world that were altered as a result of trauma. Clients can work at their own pace. Retention Incentive (RI). Participants will be told at baseline that they can earn discounts for other users with PTSD if they message with their therapist regularly. |
|
| CPT-Text + Reminder As Usual | Experimental | CPT-Text. CPT is a 12-session, trauma-focused, cognitive therapy that teaches clients to examine and change problematic beliefs about themselves and the world that were altered as a result of trauma. Reminder as Usual (RAU). As per Talkspace guidelines, therapists are available to client participants twice per day, five days per week. In the event a client participant has not engaged or messaged in 48 hours, therapists send a personalized message to the client participant to encourage them to re-engage. |
|
| Culturally Informed Trauma Treatment (CITT) + Incentive | Active Comparator | CITT will be conducted by Talkspace therapists with a specialty in PTSD culturally informed PTSD treatment. Retention Incentive for other users with PTSD in subsequent months if they message with their therapist regularly. |
|
| CITT+ Reminder as Usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPT-Text | Behavioral | CPT is a 12-session (13 modules), trauma-focused, cognitive therapy that teaches clients to examine and change problematic beliefs about themselves and the world that were altered as a result of trauma. Each session includes psychoeducation and introduction of a new skill or module, which builds on the previous information and skills. Participants will receive psychoeducation video links via Talkspace and an electronic workbook with handouts, written explanations of the concepts and activities, and CPT worksheets, which will be embedded in the platform and sent by the therapist at the appropriate point in the protocol. Therapists encourage the client to complete each module using the provided materials and assist clients in reflecting on their beliefs through Socratic questions and feedback on their worksheets. Clients work at their own pace, with therapists sending the skill or module after the client has practiced the previous one. Brief synchronous messaging sessions can be arranged |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD Checklist for DSM-5 (PCL-5) | The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that evaluates the degree to which individuals have been bothered by PTSD symptoms tied to their most currently distressing event [114] . The monthly version will be administered at baseline and the weekly version thereafter. | Baseline through 24 weeks |
| Engagement-Completion | Completion of the intervention, defined as 13 weeks of CPT or CITT, or completion of all CPT modules, whichever comes first OR early completer (achievement of a PCL score below 20, which indicates good end-state functioning) | 13 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) | The PHQ-9 [115,116] is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders that will be administered on the schedule outlined in the table. The PHQ-9 is the 9-item depression module and is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. | Baseline through 24 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shannon Wiltsey-Stirman, PhD | Stanford University | Principal Investigator |
| Katy Dondanville, PsyD | University of Texas Health Sciences Center for San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94025 | United States | ||
| Talkspace LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32347814 | Background | Malgaroli M, Hull TD, Wiltsey Stirman S, Resick P. Message Delivery for the Treatment of Posttraumatic Stress Disorder: Longitudinal Observational Study of Symptom Trajectories. J Med Internet Res. 2020 Apr 29;22(4):e15587. doi: 10.2196/15587. |
Not provided
Not provided
Investigators funded under this FOA will share those data via the National Database for Clinical Trials related to Mental Illness in a timely manner. The final quantitative dataset will be de-identified and individual records will include an NIMH Data Archive (NDA) Global Unique identifier when submitted to NDA. The research team will comply with other data submission and sharing requirements and schedule as provided in NIMH Data Archive Data Sharing Terms and Conditions (effective 7/1/15).
Due to the sensitive nature of therapy transcripts (even when de-identified), the investigators will request explicit consent for sharing of these data but allow participants to opt out of sharing beyond the research team and institutions.
After publication of main outcome papers for each aim
Investigators and institutions seeking data from NDA will be expected to meet data security measures, will be asked to submit a Data Use Certification co-signed by the investigator and the designated Institutional Official(s) at the NIH-recognized sponsoring institution with a current Federal Wide Assurance (FWA), and will be require to follow the procedures associated with data access described at https://ndar.nih.gov/ndarpublicweb/policies.go#sop4). Any data directly (e.g., qualitative data, outcome data) shared with other investigators would entail a data use agreement, signed by the research team and institutional authorities, and the individual(s) requesting data.
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
CITT will be conducted by Talkspace therapists with a specialty in culturally informed PTSD treatment. Reminder as Usual (RAU). As per Talkspace guidelines, therapists are available to client participants twice per day, five days per week. In the event a client participant has not engaged or messaged in 48 hours, therapists send a personalized message to the client participant to encourage them to re-engage. |
|
|
| Culturally Informed Trauma Treatment (CITT) | Behavioral | CITT will be conducted by Talkspace therapists with a specialty in PTSD treatment. Based on previous research and Talkspace's analysis of TAU and the therapists' training in culturally informed trauma treatment, it is likely CITT will include culturally informed, supportive and client-centered interventions, problem solving, and elements from EBTs such as cognitive-behavioral therapy. Brief synchronous messaging sessions can be arranged. |
|
| Retention Incentive | Behavioral | Participants will be told at baseline that they can earn free or discounted therapy for other individuals with PTSD who are in need of financial assistance if they remain consistently engaged in treatment. If client participants do not re-engage after 24 hours from the RAU (3 days without engagement), they will receive an automated text-message reminding them to message their therapist regularly (on average, every other business day) in order to get a discount donated it to a fund that will offer free or discounted therapy to individuals with PTSD who require financial assistance. Throughout treatment, participants will be sent reminders every other week of what the incentive is and how it can be acquired, in addition to feedback about whether they are on or off track to earn the discount. |
|
| Reminder as Usual | Behavioral | As per Talkspace guidelines, therapists are available to client participants twice per day, five days per week. In the event a client participant has not engaged or messaged in 48 hours, therapists send a personalized message to the client participant to encourage them to re-engage. |
|
| The Brief Inventory of Psychosocial Functioning (B-IPF) | The Brief Inventory of Psychosocial Functioning (B-IPF; [117] ) is a 7-item self-report instrument measuring respondents' level of functioning over the past 30 days in seven life domains including: romantic, family, parenting, friendship, work, education, and self-care. | Baseline through 24 weeks |
| The Client Satisfaction Questionnaire (CSQ) | The Client Satisfaction Questionnaire (CSQ; [118] ) is an 8-item measure of participant satisfaction with treatment. | Baseline through 24 weeks |
| Working Alliance Inventory, Short Form (WAI-SF) | The Working Alliance Inventory, Short Form (WAI-SF, [125] ) is a measure to index the degree of therapeutic cohesion between the client and the therapist. | Week 1 through Week 12 |
| Behavioral Intention | Behavioral Intention (BI; which captures motivation to engage in a behavior) will be measured to examine patterns of motivation in our treatment conditions and to investigate BI as the hypothesized mechanism of change in engagement. BI measures are created based on recommendations for constructing a very brief BI measure, a frequent approach to measuring this construct, which has demonstrated reliability [119-123] . Participants will be asked, "How likely or unlikely are you to complete (baseline) or continue (mid-treatment) treatment?" on a 7-item Likert scale ranging from "Extremely Unlikely" to "Extremely Likely" at the baseline and both mid-treatment assessments. | Baseline through week 8 |
| Oppression-based traumatic stress inventory | An assessment of trauma-related symptoms related to oppression or race/ethnicity-based trauma. | Baseline through 24 weeks at 3 timepoints |
| Post-traumatic Cognitions Inventory | Assessment of common beliefs after trauma | baseline through 24 weeks, at 3 timepoints |
| Self-Report Altruism Scale (SRA) | Assessment of altruism via self-report | Baseline |
| Cultural Humility Scale (CHS) | Assessment of important and central aspects of one's identity Assessment of customer perceptions of staff's cultural humility | Week 1 through week 13, at 4 timepoints |
| Cultural Missed Opportunities (CMO) | Assessment of degree to which clients perceived that their therapist missed opportunities to discuss their cultural identity. | Week 1 through week 13, at 4 timepoints |
| Engagement | THe number of days the client messaged divided by the total intervention days (days of active treatment before early response or 13 weeks, whichever comes first) | 13 weeks |
| Adequate Dose of CPT | Completion of at least 8 modules of CPT-Text | 13 weeks |
| New York |
| New York |
| 10025 |
| United States |
| University of Texas Health Sciences Center at San Antonio | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided