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Digitally Enhanced Stepped-Care for Depression in Primary Care

Medical University of South Carolina · NCT07634705

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
40
US sites recruiting
1
Study start
July 2, 2026
Record last updated
July 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Behavioral Activation Therapy App; Telehealth Delivered Behavioral Activation

Conditions: Depression

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Medical University of South Carolina

    Charleston, SC 29425

    Site contact: Jennifer Dahne, PhD · 843-876-2280 · dahne@musc.edu

Study contacts (from the official record)

  • Noelle Natale · 843-876-9457 · natalen@musc.edu
  • McKay Lucas · 843-876-2611 · lucasmc@musc.edu
All mental health studies in South Carolina →
Digitally Enhanced Stepped-Care for Depression in Primary Care (NCT07634705) | Bored Studies