Recruiting

Digitally Enhanced Stepped-Care for Depression in Primary Care

ClinicalTrials.gov IDNCT07634705

PhaseNA

Enrollment40

SponsorMedical University of South Carolina

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

Depression

About this study

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.

Interventions

Behavioral: Behavioral Activation Therapy App — 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.
Behavioral: Telehealth Delivered Behavioral Activation — 8 sessions of telehealth-delivered Behavioral Activation with a mental health provider over a 10-week period.

Primary outcomes

Feasibility of Digitally Enhanced Stepped-Care (12 weeks)

Eligibility information

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

Study locations

Medical University of South Carolina, Charleston, South Carolina 29425 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-26.