Development and Preliminary Testing of a Non-regulated Digital Service That Supports Cognitive Behavioral Therapy for Depressive Symptoms Under Clinical Supervision
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Major Depressive Disorder
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Drop-Out Rates
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
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
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.
Investigators
Sabine Wilhelm, PhD
Chief of Psychology
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Drop-Out Rates
Time Frame: assessed at end-of-treatment (week 8)
To determine feasibility, we will report rates of and reasons for participant dropout from the trial.
Change in Patient Satisfaction (as Measured by the CSQ-8)
Time Frame: Measured at midpoint (week 4) and end-of-treatment (week 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.
Change in Treatment Credibility (as Measured by the CEQ)
Time Frame: Change in credibility from baseline (week 0) to midpoint (week 4)
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 Outcome Expectancy (as Measured by the CEQ)
Time Frame: Measured at baseline (week 0) and midpoint (week 4)
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.
App Rating (as Measured by the uMARS)
Time Frame: Measured at endpoint (week 8)
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.
Change in Treatment Utilization
Time Frame: Measured at midpoint (week 4) and end-of-treatment (week 8)
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.
Secondary Outcomes
- Change in MDD Symptom Severity (as Measured by the HAM-D)(Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up))
- Change in Functional Impairment (as Measured by the WSAS)(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)(Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up))