Therapist-Guided Smartphone-Delivered CBT for MDD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Development and Preliminary Testing of a Non-regulated Digital Service That Supports Cognitive Behavioral Therapy for Depressive Symptoms Under Clinical Supervision

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Mindset: Therapist-guided smartphone-delivered CBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults Living in Massachusetts Current primary diagnosis of depression at least moderately severe current symptoms of depression Exclusion Criteria: Recent or anticipated changes in psychotropic medication use Past participation in a course of CBT for depression Current severe substance use disorder Lifetime bipolar disorder or psychosis Acute, active suicidal ideation Concurrent psychological treatment Does not own a supported mobile Smartphone with a data plan Lack of technology literacy that would interfere with ability to engage with smartphone treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Interventional study without concurrent control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapist-guided smartphone-delivered CBT<br>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. | Behavioral: Mindset: Therapist-guided smartphone-delivered CBT<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 are scored on Likert scales ranging from 1 to 9 (e.g., 1 means 'not at all', 5 'somewhat', and 9 'very much') that assess clients' impressions of the treatment credibility. 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 (e.g., 1 means 'not at all', 5 'somewhat', and 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) | 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), app subjectivity quality (4 items), and perceived impact (6 items). 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 all questions (range of 1-5), where higher scores meaning higher overall perceived app quality. | Measured at endpoint (week 8) | 
| Change in Treatment Utilization | Treatment utilization is 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 are collected as number of minutes in integer format, where more time spent on and off the app is interpreted as greater treatment utilization. | Measured at midpoint (week 4) and end-of-treatment (week 8) | 

Secondary Outcome Measures

| Outcome Measure | 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. | Measured at baseline, week 4, week 8 (end of treatment)] | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital Health, Cognitive Behavioral Therapy, Depression, Smartphone Apps, mHealth, Feasibility, Acceptability, Mobile App, Mental Health