Trial Outcomes & Findings for Therapist-Guided Smartphone-Delivered CBT for MDD (NCT NCT05386329)
NCT ID: NCT05386329
Last Updated: 2025-05-28
Results Overview
To determine feasibility, we will report rates of and reasons for participant dropout from the trial.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
assessed at end-of-treatment (week 8)
Results posted on
2025-05-28
Participant Flow
Participant milestones
| Measure |
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.
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Overall Study
STARTED
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28
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Overall Study
End of Treatment
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26
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Overall Study
COMPLETED
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25
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
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.
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Overall Study
Lost to Follow-up
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3
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Baseline Characteristics
Therapist-Guided Smartphone-Delivered CBT for MDD
Baseline characteristics by cohort
| Measure |
Therapist-guided Smartphone-delivered CBT
n=28 Participants
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.
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Age, Continuous
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33.5 years
STANDARD_DEVIATION 10.9 • n=5 Participants
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Sex: Female, Male
Female
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21 Participants
n=5 Participants
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Sex: Female, Male
Male
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7 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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5 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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23 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race/Ethnicity, Customized
White
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20 Participants
n=5 Participants
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Race/Ethnicity, Customized
Black
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Asian/Pacific Islander
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3 Participants
n=5 Participants
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Race/Ethnicity, Customized
Other
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4 Participants
n=5 Participants
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Region of Enrollment
United States
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28 participants
n=5 Participants
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Sexual orientation
Straight or heterosexual
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20 Participants
n=5 Participants
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Sexual orientation
Bisexual
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5 Participants
n=5 Participants
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Sexual orientation
Lesbian, gay, or homosexual
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1 Participants
n=5 Participants
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Sexual orientation
Other
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2 Participants
n=5 Participants
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Education
<= High school graduate
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4 Participants
n=5 Participants
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Education
Technical school / some college
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5 Participants
n=5 Participants
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Education
College graduate
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11 Participants
n=5 Participants
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Education
Graduate or professional school
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8 Participants
n=5 Participants
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Marital status
Single, never married
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19 Participants
n=5 Participants
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Marital status
Married
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5 Participants
n=5 Participants
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Marital status
Partnered
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2 Participants
n=5 Participants
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Marital status
Separated / widowed
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2 Participants
n=5 Participants
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Employment
Full-time (>= 35 h/wk)
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24 Participants
n=5 Participants
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Employment
Student
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2 Participants
n=5 Participants
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Employment
Unemployed
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1 Participants
n=5 Participants
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Employment
Retired
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1 Participants
n=5 Participants
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Household income
$34,999 or less
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3 Participants
n=5 Participants
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Household income
$35,000 - 74,999
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7 Participants
n=5 Participants
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Household income
$75,000 - 149,999
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14 Participants
n=5 Participants
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Household income
$150,000 or more
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4 Participants
n=5 Participants
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Geographic location
Urban
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12 Participants
n=5 Participants
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Geographic location
Suburban
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13 Participants
n=5 Participants
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Geographic location
Rural
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3 Participants
n=5 Participants
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Duration of major depressive disorder (MDD), years
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15.5 years
STANDARD_DEVIATION 12.7 • n=5 Participants
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Number of current comorbid MINI diagnoses
None
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15 Participants
n=5 Participants
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Number of current comorbid MINI diagnoses
1
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10 Participants
n=5 Participants
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Number of current comorbid MINI diagnoses
2
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0 Participants
n=5 Participants
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Number of current comorbid MINI diagnoses
3 or more
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3 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: assessed at end-of-treatment (week 8)Population: Data was analyzed in an intent to treat analysis.
To determine feasibility, we will report rates of and reasons for participant dropout from the trial.
Outcome measures
| Measure |
Therapist-guided Smartphone-delivered CBT
n=28 Participants
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.
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Drop-Out Rates
Lost contact
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2 Participants
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Drop-Out Rates
Completed treatment period
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26 Participants
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PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Therapist-guided Smartphone-delivered CBT
n=27 Participants
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.
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Change in Patient Satisfaction (as Measured by the CSQ-8)
Week 4
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26.3 score on a scale
Standard Deviation 4.0
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Change in Patient Satisfaction (as Measured by the CSQ-8)
Week 8
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27.2 score on a scale
Standard Deviation 3.3
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PRIMARY outcome
Timeframe: Change in credibility from baseline (week 0) to midpoint (week 4)Population: Data was analyzed in an intent to treat analysis.
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.
Outcome measures
| Measure |
Therapist-guided Smartphone-delivered CBT
n=28 Participants
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.
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Change in Treatment Credibility (as Measured by the CEQ)
Week 0
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18.9 score on a scale
Standard Deviation 3.1
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Change in Treatment Credibility (as Measured by the CEQ)
Week 4
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19.3 score on a scale
Standard Deviation 3.8
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PRIMARY outcome
Timeframe: Measured at baseline (week 0) and midpoint (week 4)Population: Data was analyzed in an intent to treat analysis.
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.
Outcome measures
| Measure |
Therapist-guided Smartphone-delivered CBT
n=28 Participants
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.
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Change in Outcome Expectancy (as Measured by the CEQ)
Week 0
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13.8 score on a scale
Standard Deviation 3.3
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Change in Outcome Expectancy (as Measured by the CEQ)
Week 4
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15.0 score on a scale
Standard Deviation 5.4
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PRIMARY outcome
Timeframe: Measured at endpoint (week 8)Population: Data was analyzed from people who completed questionnaires at week 8 (i.e., n=26/28; "completers").
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.
Outcome measures
| Measure |
Therapist-guided Smartphone-delivered CBT
n=26 Participants
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.
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App Rating (as Measured by the uMARS)
Engagement
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3.6 units on a scale
Standard Deviation 0.6
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App Rating (as Measured by the uMARS)
Functionality
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4.5 units on a scale
Standard Deviation 0.6
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App Rating (as Measured by the uMARS)
Aesthetics
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4.6 units on a scale
Standard Deviation 0.5
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App Rating (as Measured by the uMARS)
Information quality
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4.6 units on a scale
Standard Deviation 0.4
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App Rating (as Measured by the uMARS)
Overall app rating score
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4.3 units on a scale
Standard Deviation 0.4
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PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Therapist-guided Smartphone-delivered CBT
n=27 Participants
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.
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Change in Treatment Utilization
Week 4
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50 minutes
Interval 30.0 to 60.0
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Change in Treatment Utilization
Week 8
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60 minutes
Interval 30.0 to 90.0
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SECONDARY outcome
Timeframe: Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up)Population: Data was analyzed in an intent to treat analysis.
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.
Outcome measures
| Measure |
Therapist-guided Smartphone-delivered CBT
n=28 Participants
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.
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Change in MDD Symptom Severity (as Measured by the HAM-D)
Week 0
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19.1 score on a scale
Standard Deviation 5.0
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Change in MDD Symptom Severity (as Measured by the HAM-D)
Week 4
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15.0 score on a scale
Standard Deviation 6.1
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Change in MDD Symptom Severity (as Measured by the HAM-D)
Week 8
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10.8 score on a scale
Standard Deviation 6.1
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Change in MDD Symptom Severity (as Measured by the HAM-D)
Week 20
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9.8 score on a scale
Standard Deviation 7.8
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SECONDARY outcome
Timeframe: Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up)Population: Data was analyzed in an intent to treat analysis.
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.
Outcome measures
| Measure |
Therapist-guided Smartphone-delivered CBT
n=28 Participants
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.
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Change in Functional Impairment (as Measured by the WSAS)
Week 0
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23.1 score on a scale
Standard Deviation 7.8
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Change in Functional Impairment (as Measured by the WSAS)
Week 4
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18.6 score on a scale
Standard Deviation 7.9
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Change in Functional Impairment (as Measured by the WSAS)
Week 8
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13.0 score on a scale
Standard Deviation 7.7
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Change in Functional Impairment (as Measured by the WSAS)
Week 20
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12.3 score on a scale
Standard Deviation 9.1
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SECONDARY outcome
Timeframe: Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up)Population: Data was analyzed in an intent to treat analysis.
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.
Outcome measures
| Measure |
Therapist-guided Smartphone-delivered CBT
n=28 Participants
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.
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Change in Quality of Life (as Measured by the Q-LES-Q-SF)
Week 0
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40.9 score on a scale
Standard Deviation 11.4
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Change in Quality of Life (as Measured by the Q-LES-Q-SF)
Week 4
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52.4 score on a scale
Standard Deviation 13.1
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Change in Quality of Life (as Measured by the Q-LES-Q-SF)
Week 8
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62.9 score on a scale
Standard Deviation 13.5
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Change in Quality of Life (as Measured by the Q-LES-Q-SF)
Week 20
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63.6 score on a scale
Standard Deviation 14.3
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Adverse Events
Therapist-guided Smartphone-delivered CBT
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Therapist-guided Smartphone-delivered CBT
n=28 participants at risk
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.
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Psychiatric disorders
Increased anxiety or depression
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21.4%
6/28 • 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.
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in a full event report. All serious adverse events are reported. Of non-serious events, only those affecting \>5% in either treatment group are reported.
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Psychiatric disorders
Suicidal ideation worsening
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17.9%
5/28 • 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.
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in a full event report. All serious adverse events are reported. Of non-serious events, only those affecting \>5% in either treatment group are reported.
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Psychiatric disorders
Insomnia
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10.7%
3/28 • 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.
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in a full event report. All serious adverse events are reported. Of non-serious events, only those affecting \>5% in either treatment group are reported.
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Injury, poisoning and procedural complications
Bruising
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7.1%
2/28 • 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.
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in a full event report. All serious adverse events are reported. Of non-serious events, only those affecting \>5% in either treatment group are reported.
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Infections and infestations
Other *
|
17.9%
5/28 • 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.
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in a full event report. All serious adverse events are reported. Of non-serious events, only those affecting \>5% in either treatment group are reported.
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Additional Information
Director, Center for OCD and Related Disorders
Massachusetts General Hospital, Department of Psychiatry
Phone: 617-724-6146
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place