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This study will examine the efficacy of digital CBT versus waitlist in improving symptoms for adults with Major Depressive Disorder.
This study aims to examine the effectiveness of app-based digital CBT in individuals with a diagnosis of Major Depressive Disorder. The primary outcomes are depression symptom reduction and engagement with fulfilling activities after 5 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital CBT | Experimental | digitally-delivered CBT for depression accessed via mobile app |
|
| Waitlist | Other | Participants will wait for 5 weeks prior to receiving the intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital CBT | Device | An app-based intervention based on principles from cognitive behavioral therapy for depression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire (PHQ-8) | Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity | 5 weeks post-randomization |
| Environmental Reward Observation Scale (EROS) | A validated 10 item scale with total scores between 10 and 40 where higher scores indicate greater engagement with rewarding or fulfilling life activities | 5 weeks post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire (PHQ-8) | Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity | 10 weeks post-randomization |
| Montgomery-Ã…sberg Depression Rating Scale (MADRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Big Health Inc. | San Francisco | California | 94108 | United States |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Waitlist | Other | Participants will wait for 5 weeks prior to receiving the intervention |
|
A validated 10 item observer-rated scale with total scores between 0 and 60 where higher scores indicate greater severity
| 5 and 10 weeks post-randomization |
| World Health Organization 5-item Wellbeing Index (WHO-5) | Validated questionnaire; a 5-item scale with raw total scores between 0 and 25 where higher scores indicate greater wellbeing | Weeks 5 and 10 post-randomization |
| Environmental Reward Observation Scale (EROS) | A validated 10 item scale with total scores between 10 and 40 where higher scores indicate greater engagement with rewarding or fulfilling life activities | 10 weeks post-randomization |