Major Depressive DisorderNCT05386329

Therapist-Guided Smartphone-Delivered CBT for MDD

A study testing Mindset: Therapist-guided smartphone-delivered CBT in people with Major Depressive Disorder, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Major Depressive Disorder
What is being tested?: Mindset: Therapist-guided smartphone-delivered CBT
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: 11 May 2022to 7 Aug 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts
Boston, Massachusetts, 02214

Other trials in United States

About this study

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

Read the 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.

Conditions: Major Depressive Disorder
Being tested: Mindset: Therapist-guided smartphone-delivered CBT
Keywords: Digital Health, Cognitive Behavioral Therapy, Depression, Smartphone Apps, mHealth, Feasibility, Acceptability, Mobile App, Mental Health
Medical subject headings: Depressive Disorder, Major, Depression, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindset: Therapist-guided smartphone-delivered CBTBehavioural
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.

Study groups in NCT05386329
Study group	Role	What they receive
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. Receives: Behavioral: Mindset: Therapist-guided smartphone-delivered CBT

What is being measured

The primary outcome is the main question the study is designed to answer.

Drop-Out Rates
To determine feasibility, we will report rates of and reasons for participant dropout from the trial.
Measured: 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: 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.
Measured: 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: 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: 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: 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)
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: 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: 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: Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 May 20227 Aug 2023

First posted23 May 2022
Study start11 May 2022
Primary completion21 Apr 2023
Study completion7 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Interventional study without concurrent control
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05386329
Sponsor's protocol ID: 2020P001958
Status last verified: May 2025
First submitted: 19 Apr 2022
Last updated: 28 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 39993308
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.
PubMed 38592771

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development and Preliminary Testing of a Non-regulated Digital Service That Supports Cognitive Behavioral Therapy for Depressive Symptoms Under Clinical Supervision
ClinicalTrials.gov ID: NCT05386329
Acronym / sponsor ID: 2020P001958
Conditions: Major Depressive Disorder
Keywords: Digital Health, Cognitive Behavioral Therapy, Depression, Smartphone Apps, mHealth, Feasibility, Acceptability, Mobile App
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: Koa Health B.V.
Study start: 11 May 2022 (actual)
Primary completion: 21 Apr 2023 (actual)
Study completion: 7 Aug 2023 (actual)
First posted: 23 May 2022 (actual)
Results: Posted 28 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Interventional study without concurrent control

Arm	Type	Receives
Therapist-guided smartphone-delivered CBT	Experimental	Behavioral: Mindset: Therapist-guided smartphone-delivered CBTParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mindset: Therapist-guided smartphone-delivered CBTAll 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.	Behavioural	Therapist-guided smartphone-delivered CBT

Primary outcome

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.

3 secondary outcomes

Change in MDD Symptom Severity (as Measured by the HAM-D)
Time frame: Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up)
Change in Functional Impairment (as Measured by the WSAS)
Time frame: 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)
Time frame: Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up)

Results and safety

Results posted to the registry on 28 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Therapist-guided Smartphone-delivered CBT	28	25

Primary outcome: Drop-Out Rates

Time frame: assessed at end-of-treatment (week 8). Count of participants. Unit: Participants

Measure	Therapist-guided Smartphone-delivered CBT n = 28
Lost contact	2
Completed treatment period	26

Population analysed: Data was analyzed in an intent to treat analysis.

Primary outcome: Change in Patient Satisfaction (as Measured by the CSQ-8)

Time frame: Measured at midpoint (week 4) and end-of-treatment (week 8). Mean (Standard Deviation). Unit: score on a scale

Measure	Therapist-guided Smartphone-delivered CBT n = 27
Week 4	26.3 (4.0)
Week 8	27.2 (3.3)

Therapist-guided Smartphone-delivered CBT: Mean Difference (Final Values): 1.0308 (95% CI -0.09883 to 2.1605), p =.0719, Mixed Models Analysis

Population analysed: 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.

Primary outcome: Change in Treatment Credibility (as Measured by the CEQ)

Time frame: Change in credibility from baseline (week 0) to midpoint (week 4). Mean (Standard Deviation). Unit: score on a scale

Measure	Therapist-guided Smartphone-delivered CBT n = 28
Week 0	18.9 (3.1)
Week 4	19.3 (3.8)

Therapist-guided Smartphone-delivered CBT: Mean Difference (Final Values): 0.4296 (95% CI -1.3884 to 2.2475), p =.6316, Mixed Models Analysis

Population analysed: Data was analyzed in an intent to treat analysis.

Primary outcome: Change in Outcome Expectancy (as Measured by the CEQ)

Time frame: Measured at baseline (week 0) and midpoint (week 4). Mean (Standard Deviation). Unit: score on a scale

Measure	Therapist-guided Smartphone-delivered CBT n = 28
Week 0	13.8 (3.3)
Week 4	15.0 (5.4)

Therapist-guided Smartphone-delivered CBT: Mean Difference (Final Values): 1.1512 (95% CI -0.7422 to 3.0446), p =.2225, Mixed Models Analysis

Population analysed: Data was analyzed in an intent to treat analysis.

3 secondary outcomes are reported in the full results.

Adverse events

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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Therapist-guided Smartphone-delivered CBT	0 of 28 (0%)	18 of 28 (64.3%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39993308Bernstein 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.
Derived from this study: PubMed 38592771Wilhelm 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sabine Wilhelm principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mindset: Therapist-guided smartphone-delivered CBT in people with Major Depressive Disorder, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Drop-Out Rates (time frame: assessed at end-of-treatment (week 8)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05386329, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.