Medical University of South Carolina
This pilot, three-arm randomized clinical trial (N=40; 2:1:1) will evaluate the feasibility and preliminary efficacy of a digitally enhanced stepped-care approach for depression treatment in primary care. Participants will be randomized to: (1) stepped-care beginning with a self-guided Behavioral Activation app (Moodivate), with stepping to clinician-delivered telebehavioral health Behavioral Activation at Week 2 based on app engagement and early PHQ-9 change; (2) telebehavioral health Behavioral Activation; or (3) Moodivate alone. The primary endpoint is feasibility of the stepped-care approach, defined as continued engagement after stepping (≥1 Moodivate use/week for \>4 weeks or ≥4 therapy sessions). The secondary endpoint is change in PHQ-9 scores from baseline through Week 12. The study will be conducted within MUSC Primary Care clinics across South Carolina using remote screening, e-consent, and REDCap assessments.
Inclusion Criteria: * elevated depression symptoms (score of \>=10 on the PHQ-9) * age \>=18 years * owns an iOS or Android smartphone * willing to use Moodivate * willing to engage in telehealth depression treatment * access to email or text messaging (for assessments) * English fluency Exclusion Criteria: * current receipt of psychosocial depression treatment (e.g., individual or group therapy) * current suicidal ideation, defined as a response \>=1 ("several days") on PHQ-9 item nine * does not live in the state of South Carolina
Moodivate focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood. Participants will be asked to complete questionnaire measures at baseline and weeks 1, 2, 4, 6, 8, and 12.
8 sessions of telehealth-delivered Behavioral Activation with a mental health provider over a 10-week period.
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