NCT05386329

Therapist-Guided Smartphone-Delivered CBT for MDD

Completed NA Results posted Last updated 28 May 2025

What this trial tests

NA trial testing Mindset: Therapist-guided smartphone-delivered CBT in Major Depressive Disorder in 28 participants. Completed in 7 August 2023.

Timeline

11 May 2022

Primary endpoint
21 April 2023

7 August 2023

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	11 May 2022
Primary completion	21 April 2023
Estimated completion	7 August 2023
Sites	1 location across United States

Drugs / interventions tested

• Mindset: Therapist-guided smartphone-delivered CBT

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Drop-Out Rates Primary · assessed at end-of-treatment (week 8)

To determine feasibility, we will report rates of and reasons for participant dropout from the trial.

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	2
Therapist-guided Smartphone-delivered CBT	26

Change in Patient Satisfaction (as Measured by the CSQ-8) Primary · 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.

Week 4

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	26.3	± 4.0

Week 8

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	27.2	± 3.3

Change in Treatment Credibility (as Measured by the CEQ) Primary · 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.

Week 0

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	18.9	± 3.1

Week 4

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	19.3	± 3.8

Change in Outcome Expectancy (as Measured by the CEQ) Primary · 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.

Week 0

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	13.8	± 3.3

Week 4

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	15.0	± 5.4

App Rating (as Measured by the uMARS) Primary · 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

Engagement

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	3.6	± 0.6

Functionality

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	4.5	± 0.6

Aesthetics

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	4.6	± 0.5

Information quality

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	4.6	± 0.4

Overall app rating score

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	4.3	± 0.4

Change in Treatment Utilization Primary · 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.

Week 4

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	50	30 – 60

Week 8

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	60	30 – 90

Change in MDD Symptom Severity (as Measured by the HAM-D) Secondary · Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up)

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.

Week 0

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	19.1	± 5.0

Week 4

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	15.0	± 6.1

Week 8

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	10.8	± 6.1

Week 20

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	9.8	± 7.8

Change in Functional Impairment (as Measured by the WSAS) Secondary · Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up)

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.

Week 0

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	23.1	± 7.8

Week 4

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	18.6	± 7.9

Week 8

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	13.0	± 7.7

Week 20

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	12.3	± 9.1

Change in Quality of Life (as Measured by the Q-LES-Q-SF) Secondary · Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up)

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.

Week 0

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	40.9	± 11.4

Week 4

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	52.4	± 13.1

Week 8

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	62.9	± 13.5

Week 20

Group	Value	95% CI
Therapist-guided Smartphone-delivered CBT	63.6	± 14.3

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Therapist-guided Smartphone-delivered CBT

Serious: 0/28 (0%)

Deaths: 0/28

Other adverse events (5 terms — click to expand)

Reaction	System	Therapist-guided Smartphon…
Increased anxiety or depression	Psychiatric disorders	—
Suicidal ideation worsening	Psychiatric disorders	—
Other *	Infections and infestations	—
Insomnia	Psychiatric disorders	—
Bruising	Injury, poisoning and procedural complications	—

Data from ClinicalTrials.gov NCT05386329 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Feasibility, Acceptability, and Preliminary Efficacy of a Smartphone App-Led Cognitive Behavioral Therapy for Depression Under Therapist Supervision: Open Trial.
   Wilhelm S, Bernstein EE, Bentley KH, Snorrason I, et al · · 2024 · cited 8× · PMID 38592771 · DOI 10.2196/53998
2. Patterns of Skills Review in Smartphone Cognitive Behavioral Therapy for Depression: Observational Study of Intervention Content Use.
   Bernstein EE, Daniel KE, Miyares PE, Hoeppner SS, et al · · 2025 · cited 1× · PMID 39993308 · DOI 10.2196/63497
3. Identifying Evidence-Based Strategies in a Digital Mental Health Intervention for Depression: Qualitative Content Analysis.
   Jonathan GK, Sung JY, Arcese HT, Holz P, et al · · 2026 · PMID 41990254 · DOI 10.2196/84030