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| Name | Class |
|---|---|
| Koa Health B.V. | INDUSTRY |
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We are testing a smartphone app that provides therapy for depression. Participants will also receive short weekly virtual appointments with a therapist. Researchers want to know if this new treatment is usable, whether participants are satisfied with it, and whether it can help lower symptoms.
The purpose of this project is to conduct an open trial to test the feasibility, acceptability, and preliminary efficacy of a new therapist-guided smartphone-delivered cognitive behavioral therapy (CBT) for major depressive disorder (MDD). This treatment will include unlimited access to the mobile CBT for depression app over 8 weeks plus 8 virtual visits with a doctoral-level psychologist or psychology intern with their master's degree. The therapist will be assigned once eligibility is determined. All virtual sessions will be no longer than 16-25 min. The combined CBT app plus virtual treatment will be tested in 28 patients. Clinical assessments will occur at baseline, mid-treatment (week 4), end-of-treatment (week 8), and 3 month follow-up. The investigators hypothesize that this treatment will be feasible, acceptable to participants, and lead to reductions in depression symptoms and functional impairment as well as improvements in quality of life from baseline to end-of-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapist-guided smartphone-delivered CBT | Experimental | Participants will complete app-based cognitive-behavioral therapy (CBT) treatment for major depressive disorder (MDD) through their personal mobile smartphone. They will also be assigned a therapist, who will provide brief virtual treatment sessions (up to 25 minutes via a video platform) over the course of the same treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindset: Therapist-guided smartphone-delivered CBT | Behavioral | All participants will receive the app-delivered CBT, including modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., activity scheduling), and mindfulness. Therapists will also conduct brief weekly virtual appointments with participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Drop-Out Rates | To determine feasibility, we will report rates of and reasons for participant dropout from the trial. | assessed at end-of-treatment (week 8) |
| Change in Patient Satisfaction (as Measured by the CSQ-8) | The Client Satisfaction Questionnaire (CSQ) is an 8-item self-report questionnaire which assesses the satisfaction with clinical services received. Each item uses a 4-point Likert scale. Items are summed for a total score ranging from 8 to 32, with higher scores indicating greater satisfaction. | Measured at midpoint (week 4) and end-of-treatment (week 8) |
| Change in Treatment Credibility (as Measured by the CEQ) | The Credibility/Expectancy Questionnaire (CEQ) is a 6-item, self-report questionnaire. Items 1-3 assess clients' impressions of the treatment credibility; they are scored on Likert scales ranging from 1 to 9 (e.g., from 1='not at all' to 9='very much'). Items are summed for a total score that can range from 3 to 27, where higher scores mean greater treatment credibility. | Change in credibility from baseline (week 0) to midpoint (week 4) |
| Change in Outcome Expectancy (as Measured by the CEQ) | The Credibility/Expectancy Questionnaire (CEQ) is a 6-item, self-report questionnaire. Items 4-6 are used to assess clients' outcome expectancy. Item 5 is scored on a Likert scale ranging from 1 to 9 (where 1='not at all' to 9='very much'). Items 4 and 6 are scored on a scale from 0% to 100% (in 10-point increments); their scores are then converted linearly on a Likert scale from 1 to 9. Items are summed together for a total outcome expectancy score that can range from 3 to 27, where higher scores mean a higher outcome expectancy. | Measured at baseline (week 0) and midpoint (week 4) |
| App Rating (as Measured by the uMARS) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in MDD Symptom Severity (as Measured by the HAM-D) | The Hamilton Depression Rating Scale (HAM-D) is the gold-standard clinician-administered assessment of depression symptom severity. It contains 21 items that are rated on a mixture of 3- and 5-point Likert scales. The first 17 items are summed for the total score, which can range from 0 to 52. Higher scores indicate greater depression severity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sabine Wilhelm | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts | Boston | Massachusetts | 02214 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39993308 | Derived | Bernstein EE, Daniel KE, Miyares PE, Hoeppner SS, Bentley KH, Snorrason I, Fisher LB, Greenberg JL, Weingarden H, Harrison O, Wilhelm S. Patterns of Skills Review in Smartphone Cognitive Behavioral Therapy for Depression: Observational Study of Intervention Content Use. JMIR Ment Health. 2025 Feb 24;12:e63497. doi: 10.2196/63497. | |
| 38592771 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Therapist-guided Smartphone-delivered CBT | Participants will complete app-based cognitive-behavioral therapy (CBT) treatment for major depressive disorder (MDD) through their personal mobile smartphone. They will also be assigned a therapist, who will provide brief virtual treatment sessions (up to 25 minutes via a video platform) over the course of the same treatment period. Mindset: Therapist-guided smartphone-delivered CBT: All participants will receive the app-delivered CBT, including modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., activity scheduling), and mindfulness. Therapists will also conduct brief weekly virtual appointments with participants. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Therapist-guided Smartphone-delivered CBT | Participants will complete app-based cognitive-behavioral therapy (CBT) treatment for major depressive disorder (MDD) through their personal mobile smartphone. They will also be assigned a therapist, who will provide brief virtual treatment sessions (up to 25 minutes via a video platform) over the course of the same treatment period. Mindset: Therapist-guided smartphone-delivered CBT: All participants will receive the app-delivered CBT, including modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., activity scheduling), and mindfulness. Therapists will also conduct brief weekly virtual appointments with participants. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Drop-Out Rates | To determine feasibility, we will report rates of and reasons for participant dropout from the trial. | Data was analyzed in an intent to treat analysis. | Posted | Count of Participants | Participants | assessed at end-of-treatment (week 8) |
|
Adverse event data was collected during study assessments at week 4, week 8, and the 3-month follow-up. At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment.
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in a full event report. All serious adverse events are reported. Of non-serious events, only those affecting >5% in either treatment group are reported.
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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 | Therapist-guided Smartphone-delivered CBT | Participants will complete app-based cognitive-behavioral therapy (CBT) treatment for major depressive disorder (MDD) through their personal mobile smartphone. They will also be assigned a therapist, who will provide brief virtual treatment sessions (up to 25 minutes via a video platform) over the course of the same treatment period. Mindset: Therapist-guided smartphone-delivered CBT: All participants will receive the app-delivered CBT, including modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., activity scheduling), and mindfulness. Therapists will also conduct brief weekly virtual appointments with participants. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased anxiety or depression | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Center for OCD and Related Disorders | Massachusetts General Hospital, Department of Psychiatry | 617-724-6146 | swilhelm@mgh.harvard.edu |
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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 | Nov 14, 2023 | Nov 16, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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Interventional study without concurrent control
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The Mobile Application Rating Scale user version (uMARS) is a self-report form with 26 items that assess participant's evaluations of various app features. Dimensions of this measure include engagement (5 items), functionality (4 items), aesthetics (3 items), information quality (4 items); other items about app subjectivity quality (4 items) and perceived impact (6 items) are also available but do not contribute to the overall score (and are not reported here). Items are rated on differently worded 5-point Likert scales ranging from 1 (Inadequate) to 5 (Excellent). An overall app rating score can be calculated as the mean score of the first four subscales (engagement, functionality, aesthetics, and information quality; range of 1-5), where higher scores indicate higher overall perceived app quality.
| Measured at endpoint (week 8) |
| Change in Treatment Utilization | Treatment utilization was assessed with a single question: "On average, how much time (in minutes) do you spend using the app or practicing skills from the app in total, per week?" Answers were collected as number of minutes in integer format, where more time spent on and off the app was interpreted as greater treatment utilization. | Measured at midpoint (week 4) and end-of-treatment (week 8) |
| Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up) |
| Change in Functional Impairment (as Measured by the WSAS) | The Work and Social Adjustment Scale (WSAS) is a self-report measure that assesses impairment in occupational, social, and family areas. The WSAS is a 5-item measure that uses 9-point Likert scales ranging from 0 (no impairment at all) to 8 (very severe impairment). The items are summed for a total score ranging from 0 to 40, where higher scores mean higher functional impairment. | Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up) |
| Change in Quality of Life (as Measured by the Q-LES-Q-SF) | The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) is a 16-item, self-report questionnaire that assesses life satisfaction over the past week. Each question is rated on a 5-point Likert scale ranging from 1 (very poor) to 5 (very good). Questions 1-15 are then summed to a total score, and the total score is reported as a percentage maximum possible, such that the final percent score range is 0% to 100%, with higher scores indicating greater quality of life. | Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up) |
| Wilhelm S, Bernstein EE, Bentley KH, Snorrason I, Hoeppner SS, Klare D, Greenberg JL, Weingarden H, McCoy TH, Harrison O. Feasibility, Acceptability, and Preliminary Efficacy of a Smartphone App-Led Cognitive Behavioral Therapy for Depression Under Therapist Supervision: Open Trial. JMIR Ment Health. 2024 Apr 9;11:e53998. doi: 10.2196/53998. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Sexual orientation | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Marital status | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
| Household income | Count of Participants | Participants |
|
| Geographic location | Count of Participants | Participants |
|
| Duration of major depressive disorder (MDD), years | Mean | Standard Deviation | years |
|
| Number of current comorbid MINI diagnoses | Count of Participants | Participants |
|
|
|
| Primary | Change in Patient Satisfaction (as Measured by the CSQ-8) | The Client Satisfaction Questionnaire (CSQ) is an 8-item self-report questionnaire which assesses the satisfaction with clinical services received. Each item uses a 4-point Likert scale. Items are summed for a total score ranging from 8 to 32, with higher scores indicating greater satisfaction. | Data was analyzed in an intent to treat analysis with all people who completed questionnaires at week 4 (i.e., n=27/28). Data provided in the outcome measure data table are raw means from all available data, which includes missing data for one additional person who dropped out between week 4 and week 8. | Posted | Mean | Standard Deviation | score on a scale | Measured at midpoint (week 4) and end-of-treatment (week 8) |
|
|
|
|
| Primary | Change in Treatment Credibility (as Measured by the CEQ) | The Credibility/Expectancy Questionnaire (CEQ) is a 6-item, self-report questionnaire. Items 1-3 assess clients' impressions of the treatment credibility; they are scored on Likert scales ranging from 1 to 9 (e.g., from 1='not at all' to 9='very much'). Items are summed for a total score that can range from 3 to 27, where higher scores mean greater treatment credibility. | Data was analyzed in an intent to treat analysis. | Posted | Mean | Standard Deviation | score on a scale | Change in credibility from baseline (week 0) to midpoint (week 4) |
|
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|
| Primary | Change in Outcome Expectancy (as Measured by the CEQ) | The Credibility/Expectancy Questionnaire (CEQ) is a 6-item, self-report questionnaire. Items 4-6 are used to assess clients' outcome expectancy. Item 5 is scored on a Likert scale ranging from 1 to 9 (where 1='not at all' to 9='very much'). Items 4 and 6 are scored on a scale from 0% to 100% (in 10-point increments); their scores are then converted linearly on a Likert scale from 1 to 9. Items are summed together for a total outcome expectancy score that can range from 3 to 27, where higher scores mean a higher outcome expectancy. | Data was analyzed in an intent to treat analysis. | Posted | Mean | Standard Deviation | score on a scale | Measured at baseline (week 0) and midpoint (week 4) |
|
|
|
|
| Primary | App Rating (as Measured by the uMARS) | The Mobile Application Rating Scale user version (uMARS) is a self-report form with 26 items that assess participant's evaluations of various app features. Dimensions of this measure include engagement (5 items), functionality (4 items), aesthetics (3 items), information quality (4 items); other items about app subjectivity quality (4 items) and perceived impact (6 items) are also available but do not contribute to the overall score (and are not reported here). Items are rated on differently worded 5-point Likert scales ranging from 1 (Inadequate) to 5 (Excellent). An overall app rating score can be calculated as the mean score of the first four subscales (engagement, functionality, aesthetics, and information quality; range of 1-5), where higher scores indicate higher overall perceived app quality. | Data was analyzed from people who completed questionnaires at week 8 (i.e., n=26/28; "completers"). | Posted | Mean | Standard Deviation | units on a scale | Measured at endpoint (week 8) |
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| Primary | Change in Treatment Utilization | Treatment utilization was assessed with a single question: "On average, how much time (in minutes) do you spend using the app or practicing skills from the app in total, per week?" Answers were collected as number of minutes in integer format, where more time spent on and off the app was interpreted as greater treatment utilization. | Data was analyzed from people who completed questionnaires at week 4 (i.e., n=27/28), which was the first time this survey instrument was asked. | Posted | Median | Inter-Quartile Range | minutes | Measured at midpoint (week 4) and end-of-treatment (week 8) |
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| Secondary | Change in MDD Symptom Severity (as Measured by the HAM-D) | The Hamilton Depression Rating Scale (HAM-D) is the gold-standard clinician-administered assessment of depression symptom severity. It contains 21 items that are rated on a mixture of 3- and 5-point Likert scales. The first 17 items are summed for the total score, which can range from 0 to 52. Higher scores indicate greater depression severity. | Data was analyzed in an intent to treat analysis. | Posted | Mean | Standard Deviation | score on a scale | Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up) |
|
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| Secondary | Change in Functional Impairment (as Measured by the WSAS) | The Work and Social Adjustment Scale (WSAS) is a self-report measure that assesses impairment in occupational, social, and family areas. The WSAS is a 5-item measure that uses 9-point Likert scales ranging from 0 (no impairment at all) to 8 (very severe impairment). The items are summed for a total score ranging from 0 to 40, where higher scores mean higher functional impairment. | Data was analyzed in an intent to treat analysis. | Posted | Mean | Standard Deviation | score on a scale | Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up) |
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| Secondary | Change in Quality of Life (as Measured by the Q-LES-Q-SF) | The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) is a 16-item, self-report questionnaire that assesses life satisfaction over the past week. Each question is rated on a 5-point Likert scale ranging from 1 (very poor) to 5 (very good). Questions 1-15 are then summed to a total score, and the total score is reported as a percentage maximum possible, such that the final percent score range is 0% to 100%, with higher scores indicating greater quality of life. | Data was analyzed in an intent to treat analysis. | Posted | Mean | Standard Deviation | score on a scale | Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up) |
|
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 18 |
| 28 |
| Suicidal ideation worsening | Psychiatric disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
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| Other * | Infections and infestations | Systematic Assessment | * COVID-19, viral infection |
|
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| D001519 |
| Behavior |
| D010549 | Personal Satisfaction |
|
| Superiority |
Comparison of mid-treatment to end-of-treatment |
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| Superiority |
Comparison of mid-treatment (week 4) to baseline |
|
| Superiority |
Comparison of mid-treatment (week 4) to baseline. |
| Title | Measurements |
|---|---|
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| Information quality |
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| Overall app rating score |
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| Week 8 |
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| Week 20 |
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| Superiority |
Pre-post comparison |
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| Week 8 |
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| Week 20 |
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| Superiority |
Pre-post comparison |
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| Week 8 |
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| Week 20 |
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| Superiority |
Pre-post comparison |