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Digitally Enhanced Stepped-Care for Depression in Primary Care

RecruitingNAAges 18 Years - anyAllMedical University of South Carolina
NCT07634705 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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,

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📋 Eligibility rules (as published)
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
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What it tests

  • Behavioral Activation Therapy App
  • Telehealth Delivered Behavioral Activation
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Where

1 site
Medical University of South Carolina
Charleston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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