Major Depressive Disorder
Conditions
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
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
Study design
Intervention model description
Interventional study without concurrent control
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Change in Treatment Utilization | 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. |
| 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 Rates | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Arm | Count |
|---|---|
| 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 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Therapist-guided Smartphone-delivered CBT |
|---|---|
| Age, Continuous | 33.5 years STANDARD_DEVIATION 10.9 |
| Duration of major depressive disorder (MDD), years | 15.5 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 type | EG000 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
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Therapist-guided Smartphone-delivered CBT | App Rating (as Measured by the uMARS) | Engagement | 3.6 units on a scale | Standard Deviation 0.6 |
| Therapist-guided Smartphone-delivered CBT | App Rating (as Measured by the uMARS) | Functionality | 4.5 units on a scale | Standard Deviation 0.6 |
| Therapist-guided Smartphone-delivered CBT | App Rating (as Measured by the uMARS) | Aesthetics | 4.6 units on a scale | Standard Deviation 0.5 |
| Therapist-guided Smartphone-delivered CBT | App Rating (as Measured by the uMARS) | Information quality | 4.6 units on a scale | Standard Deviation 0.4 |
| Therapist-guided Smartphone-delivered CBT | App Rating (as Measured by the uMARS) | Overall app rating score | 4.3 units on a scale | Standard Deviation 0.4 |
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.
Time frame: Measured at baseline (week 0) and midpoint (week 4)
Population: Data was analyzed in an intent to treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Therapist-guided Smartphone-delivered CBT | Change in Outcome Expectancy (as Measured by the CEQ) | Week 0 | 13.8 score on a scale | Standard Deviation 3.3 |
| Therapist-guided Smartphone-delivered CBT | Change in Outcome Expectancy (as Measured by the CEQ) | Week 4 | 15.0 score on a scale | Standard Deviation 5.4 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Therapist-guided Smartphone-delivered CBT | Change in Patient Satisfaction (as Measured by the CSQ-8) | Week 4 | 26.3 score on a scale | Standard Deviation 4 |
| Therapist-guided Smartphone-delivered CBT | Change in Patient Satisfaction (as Measured by the CSQ-8) | Week 8 | 27.2 score on a scale | Standard Deviation 3.3 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Therapist-guided Smartphone-delivered CBT | Change in Treatment Credibility (as Measured by the CEQ) | Week 0 | 18.9 score on a scale | Standard Deviation 3.1 |
| Therapist-guided Smartphone-delivered CBT | Change in Treatment Credibility (as Measured by the CEQ) | Week 4 | 19.3 score on a scale | Standard Deviation 3.8 |
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.
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Therapist-guided Smartphone-delivered CBT | Change in Treatment Utilization | Week 4 | 50 minutes |
| Therapist-guided Smartphone-delivered CBT | Change in Treatment Utilization | Week 8 | 60 minutes |
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Therapist-guided Smartphone-delivered CBT | Drop-Out Rates | Lost contact | 2 Participants |
| Therapist-guided Smartphone-delivered CBT | Drop-Out Rates | Completed treatment period | 26 Participants |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Therapist-guided Smartphone-delivered CBT | Change in Functional Impairment (as Measured by the WSAS) | Week 0 | 23.1 score on a scale | Standard Deviation 7.8 |
| Therapist-guided Smartphone-delivered CBT | Change in Functional Impairment (as Measured by the WSAS) | Week 4 | 18.6 score on a scale | Standard Deviation 7.9 |
| Therapist-guided Smartphone-delivered CBT | Change in Functional Impairment (as Measured by the WSAS) | Week 8 | 13.0 score on a scale | Standard Deviation 7.7 |
| Therapist-guided Smartphone-delivered CBT | Change in Functional Impairment (as Measured by the WSAS) | Week 20 | 12.3 score on a scale | Standard Deviation 9.1 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Therapist-guided Smartphone-delivered CBT | Change in MDD Symptom Severity (as Measured by the HAM-D) | Week 0 | 19.1 score on a scale | Standard Deviation 5 |
| Therapist-guided Smartphone-delivered CBT | Change in MDD Symptom Severity (as Measured by the HAM-D) | Week 4 | 15.0 score on a scale | Standard Deviation 6.1 |
| Therapist-guided Smartphone-delivered CBT | Change in MDD Symptom Severity (as Measured by the HAM-D) | Week 8 | 10.8 score on a scale | Standard Deviation 6.1 |
| Therapist-guided Smartphone-delivered CBT | Change in MDD Symptom Severity (as Measured by the HAM-D) | Week 20 | 9.8 score on a scale | Standard Deviation 7.8 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Therapist-guided Smartphone-delivered CBT | Change in Quality of Life (as Measured by the Q-LES-Q-SF) | Week 0 | 40.9 score on a scale | Standard Deviation 11.4 |
| Therapist-guided Smartphone-delivered CBT | Change in Quality of Life (as Measured by the Q-LES-Q-SF) | Week 4 | 52.4 score on a scale | Standard Deviation 13.1 |
| Therapist-guided Smartphone-delivered CBT | Change in Quality of Life (as Measured by the Q-LES-Q-SF) | Week 8 | 62.9 score on a scale | Standard Deviation 13.5 |
| Therapist-guided Smartphone-delivered CBT | Change in Quality of Life (as Measured by the Q-LES-Q-SF) | Week 20 | 63.6 score on a scale | Standard Deviation 14.3 |