Digitally Enhanced Stepped-Care for Depression in Primary Care
Recruiting now · Not applicable
Conditions studied: Depression
In brief
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.
Key facts
- Study ID
- NCT07634705
- Run by
- Medical University of South Carolina
- People needed
- 40
- Starts
- 2026-07-02
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-07-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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