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Therapist-Guided Smartphone-Delivered CBT for MDD

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05386329
Enrollment
28
Registered
2022-05-23
Start date
2022-05-11
Completion date
2023-08-07
Last updated
2025-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

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

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.

Interventions

BEHAVIORALMindset: Therapist-guided smartphone-delivered CBT

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.

Sponsors

Koa Health B.V.
CollaboratorINDUSTRY
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Interventional study without concurrent control

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Treatment UtilizationMeasured 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.
Change in Treatment Credibility (as Measured by the CEQ)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)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)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.
Drop-Out Ratesassessed 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)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.

Secondary

MeasureTime frameDescription
Change in Functional Impairment (as Measured by the WSAS)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.
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)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.
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)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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Therapist-guided Smartphone-delivered CBT
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. Mindset: Therapist-guided smartphone-delivered CBT: 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.
28
Total28

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up3

Baseline characteristics

CharacteristicTherapist-guided Smartphone-delivered CBT
Age, Continuous33.5 years
STANDARD_DEVIATION 10.9
Duration of major depressive disorder (MDD), years15.5 years
STANDARD_DEVIATION 12.7
Education
College graduate
11 Participants
Education
Graduate or professional school
8 Participants
Education
<= High school graduate
4 Participants
Education
Technical school / some college
5 Participants
Employment
Full-time (>= 35 h/wk)
24 Participants
Employment
Retired
1 Participants
Employment
Student
2 Participants
Employment
Unemployed
1 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
23 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Geographic location
Rural
3 Participants
Geographic location
Suburban
13 Participants
Geographic location
Urban
12 Participants
Household income
$150,000 or more
4 Participants
Household income
$34,999 or less
3 Participants
Household income
$35,000 - 74,999
7 Participants
Household income
$75,000 - 149,999
14 Participants
Marital status
Married
5 Participants
Marital status
Partnered
2 Participants
Marital status
Separated / widowed
2 Participants
Marital status
Single, never married
19 Participants
Number of current comorbid MINI diagnoses
1
10 Participants
Number of current comorbid MINI diagnoses
2
0 Participants
Number of current comorbid MINI diagnoses
3 or more
3 Participants
Number of current comorbid MINI diagnoses
None
15 Participants
Race/Ethnicity, Customized
Asian/Pacific Islander
3 Participants
Race/Ethnicity, Customized
Black
1 Participants
Race/Ethnicity, Customized
Other
4 Participants
Race/Ethnicity, Customized
White
20 Participants
Region of Enrollment
United States
28 participants
Sex: Female, Male
Female
21 Participants
Sex: Female, Male
Male
7 Participants
Sexual orientation
Bisexual
5 Participants
Sexual orientation
Lesbian, gay, or homosexual
1 Participants
Sexual orientation
Other
2 Participants
Sexual orientation
Straight or heterosexual
20 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 28
other
Total, other adverse events
18 / 28
serious
Total, serious adverse events
0 / 28

Outcome results

Primary

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.

Time frame: Measured at endpoint (week 8)

Population: Data was analyzed from people who completed questionnaires at week 8 (i.e., n=26/28; completers).

ArmMeasureGroupValue (MEAN)Dispersion
Therapist-guided Smartphone-delivered CBTApp Rating (as Measured by the uMARS)Engagement3.6 units on a scaleStandard Deviation 0.6
Therapist-guided Smartphone-delivered CBTApp Rating (as Measured by the uMARS)Functionality4.5 units on a scaleStandard Deviation 0.6
Therapist-guided Smartphone-delivered CBTApp Rating (as Measured by the uMARS)Aesthetics4.6 units on a scaleStandard Deviation 0.5
Therapist-guided Smartphone-delivered CBTApp Rating (as Measured by the uMARS)Information quality4.6 units on a scaleStandard Deviation 0.4
Therapist-guided Smartphone-delivered CBTApp Rating (as Measured by the uMARS)Overall app rating score4.3 units on a scaleStandard Deviation 0.4
Primary

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.

Time frame: Measured at baseline (week 0) and midpoint (week 4)

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

ArmMeasureGroupValue (MEAN)Dispersion
Therapist-guided Smartphone-delivered CBTChange in Outcome Expectancy (as Measured by the CEQ)Week 013.8 score on a scaleStandard Deviation 3.3
Therapist-guided Smartphone-delivered CBTChange in Outcome Expectancy (as Measured by the CEQ)Week 415.0 score on a scaleStandard Deviation 5.4
Comparison: Null hypothesis: there is no significant difference in treatment expectancy total scores between baseline (week 0) and midpoint (week 4).p-value: =0.222595% CI: [-0.7422, 3.0446]Mixed Models Analysis
Primary

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.

Time frame: Measured at midpoint (week 4) and end-of-treatment (week 8)

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Therapist-guided Smartphone-delivered CBTChange in Patient Satisfaction (as Measured by the CSQ-8)Week 426.3 score on a scaleStandard Deviation 4
Therapist-guided Smartphone-delivered CBTChange in Patient Satisfaction (as Measured by the CSQ-8)Week 827.2 score on a scaleStandard Deviation 3.3
Comparison: Null hypothesis: there is no significant difference in CSQ-8 total scores between midpoint (week 4) and end-of-treatment (week 8).p-value: =0.071995% CI: [-0.09883, 2.1605]Mixed Models Analysis
Primary

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.

Time frame: Change in credibility from baseline (week 0) to midpoint (week 4)

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

ArmMeasureGroupValue (MEAN)Dispersion
Therapist-guided Smartphone-delivered CBTChange in Treatment Credibility (as Measured by the CEQ)Week 018.9 score on a scaleStandard Deviation 3.1
Therapist-guided Smartphone-delivered CBTChange in Treatment Credibility (as Measured by the CEQ)Week 419.3 score on a scaleStandard Deviation 3.8
Comparison: Null hypothesis: there is no significant difference in treatment credibility total scores between baseline (week 0) and midpoint (week 4).p-value: =0.631695% CI: [-1.3884, 2.2475]Mixed Models Analysis
Primary

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.

Time frame: Measured at midpoint (week 4) and end-of-treatment (week 8)

Population: Data was analyzed from people who completed questionnaires at week 4 (i.e., n=27/28), which was the first time this survey instrument was asked.

ArmMeasureGroupValue (MEDIAN)
Therapist-guided Smartphone-delivered CBTChange in Treatment UtilizationWeek 450 minutes
Therapist-guided Smartphone-delivered CBTChange in Treatment UtilizationWeek 860 minutes
Comparison: Null hypothesis: There is no significant difference in treatment utilization between midpoint (week 4) and end of treatment (week 8).p-value: =0.7873Wilcoxon (Mann-Whitney)
Primary

Drop-Out Rates

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

Time frame: assessed at end-of-treatment (week 8)

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Therapist-guided Smartphone-delivered CBTDrop-Out RatesLost contact2 Participants
Therapist-guided Smartphone-delivered CBTDrop-Out RatesCompleted treatment period26 Participants
Secondary

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.

Time frame: Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up)

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

ArmMeasureGroupValue (MEAN)Dispersion
Therapist-guided Smartphone-delivered CBTChange in Functional Impairment (as Measured by the WSAS)Week 023.1 score on a scaleStandard Deviation 7.8
Therapist-guided Smartphone-delivered CBTChange in Functional Impairment (as Measured by the WSAS)Week 418.6 score on a scaleStandard Deviation 7.9
Therapist-guided Smartphone-delivered CBTChange in Functional Impairment (as Measured by the WSAS)Week 813.0 score on a scaleStandard Deviation 7.7
Therapist-guided Smartphone-delivered CBTChange in Functional Impairment (as Measured by the WSAS)Week 2012.3 score on a scaleStandard Deviation 9.1
Comparison: Null hypothesis: there is no significant difference in WSAS total scores between baseline (week 0) and end of treatment (week 8).p-value: <0.000195% CI: [-13.5043, -6.3776]Mixed Models Analysis
Secondary

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.

Time frame: Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up)

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

ArmMeasureGroupValue (MEAN)Dispersion
Therapist-guided Smartphone-delivered CBTChange in MDD Symptom Severity (as Measured by the HAM-D)Week 019.1 score on a scaleStandard Deviation 5
Therapist-guided Smartphone-delivered CBTChange in MDD Symptom Severity (as Measured by the HAM-D)Week 415.0 score on a scaleStandard Deviation 6.1
Therapist-guided Smartphone-delivered CBTChange in MDD Symptom Severity (as Measured by the HAM-D)Week 810.8 score on a scaleStandard Deviation 6.1
Therapist-guided Smartphone-delivered CBTChange in MDD Symptom Severity (as Measured by the HAM-D)Week 209.8 score on a scaleStandard Deviation 7.8
Comparison: Null hypothesis: there is no significant difference in HAM-D total scores between baseline (week 0) and end of treatment (week 8).p-value: <0.000195% CI: [-10.4944, -5.1903]Mixed Models Analysis
Secondary

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.

Time frame: Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up)

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

ArmMeasureGroupValue (MEAN)Dispersion
Therapist-guided Smartphone-delivered CBTChange in Quality of Life (as Measured by the Q-LES-Q-SF)Week 040.9 score on a scaleStandard Deviation 11.4
Therapist-guided Smartphone-delivered CBTChange in Quality of Life (as Measured by the Q-LES-Q-SF)Week 452.4 score on a scaleStandard Deviation 13.1
Therapist-guided Smartphone-delivered CBTChange in Quality of Life (as Measured by the Q-LES-Q-SF)Week 862.9 score on a scaleStandard Deviation 13.5
Therapist-guided Smartphone-delivered CBTChange in Quality of Life (as Measured by the Q-LES-Q-SF)Week 2063.6 score on a scaleStandard Deviation 14.3
Comparison: Null hypothesis: there is no significant difference in Q-LES-Q-SF total scores between baseline (week 0) and end of treatment (week 8).p-value: <0.000195% CI: [14.512, 28.5806]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026