Therapist-Guided Smartphone-Delivered CBT for MDD

NCT05386329 | Completed Results

• 1 other identifier: 2020P001958
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Digital Health; Cognitive Behavioral Therapy; Depression; Smartphone Apps; mHealth; Feasibility; Acceptability; Mobile App; Mental Health

Outcome Measures

Primary Outcomes (6)

• 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)

  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)

Secondary Outcomes (3)

• 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)

Study Arms (1)

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.

Behavioral: Mindset: Therapist-guided smartphone-delivered CBT

Interventions

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.

Therapist-guided smartphone-delivered CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults
• Living in Massachusetts
• Current primary diagnosis of depression
• at least moderately severe current symptoms of depression

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Koa Health B.V.: collaborator

Study Sites (1)

Massachusetts

Boston, Massachusetts, 02214, United States

Location

Related Publications (2)

• 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.

  PMID: 39993308 DERIVED

• 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.

  PMID: 38592771 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Psychological Well-Being

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Results Point of Contact

• Title: Director, Center for OCD and Related Disorders
• Organization: Massachusetts General Hospital, Department of Psychiatry

swilhelm@mgh.harvard.edu

617-724-6146

Study Officials

• Sabine Wilhelm

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Psychology

Model Details: Interventional study without concurrent control

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 23, 2022
• Study Start: May 11, 2022
• Primary Completion: April 21, 2023
• Study Completion: August 7, 2023
• Last Updated: May 28, 2025
• Results First Posted: May 28, 2025

Record last verified: 2025-05

Locations

US (1)