Digitally Enhanced Stepped-Care for Depression in Primary Care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot, three-arm randomized trial will enroll 40 adults with elevated depressive symptoms from MUSC primary care clinics in South Carolina. Participants are randomized 2:1:1 to: 1) a stepped-care approach starting with the Moodivate self-guided Behavioral Activation app and stepping to clinician-delivered telebehavioral therapy at week 2 based on engagement and early PHQ-9 change; 2) telebehavioral activation delivered via telehealth; or 3) Moodivate alone. Feasibility is defined by continued engagement after stepping or a minimum level of use and therapy sessions over 12 weeks, with secondary outcomes including change in PHQ-9 from baseline to week 12. Remote screening, electronic consent, and REDCap assessments will be used, with the study conducted across MUSC primary care sites in South Carolina. Primary care clinicians and digital tools are integrated to assess whether a digitally enhanced stepped-care model is workable in real-world settings.

Why it matters

Who can join: the full rules

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

Where it's running

• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting

Study contacts

• Principal investigator: Jennifer Dahne, PhD — Medical University of South Carolina
• Study coordinator: Noelle Natale
• Email: natalen@musc.edu
• Phone: 843-876-9457

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.