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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
An app-based intervention based on principles from cognitive behavioral therapy for depression.
Participants will wait for 5 weeks prior to receiving the intervention
Big Health Inc.
San Francisco, California, United States
Patient Health Questionnaire (PHQ-8)
Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity
Time frame: 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
Time frame: 5 weeks post-randomization
Patient Health Questionnaire (PHQ-8)
Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity
Time frame: 10 weeks post-randomization
Montgomery-Åsberg Depression Rating Scale (MADRS)
A validated 10 item observer-rated scale with total scores between 0 and 60 where higher scores indicate greater severity
Time frame: 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
Time frame: 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
Time frame: 10 weeks post-randomization
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