Digitally Enhanced Stepped-Care for Depression in Primary Care

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT07634705
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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 Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Digitally-Enhanced Stepped Care
    Participants randomized to the Digitally-Enhanced Stepped Care condition will be instructed to utilize a Behavioral Activation therapy focused mobile application called "Moodivate" regularly, at least once per day, for the treatment of depressed mood among cancer survivors. Participants in the Digitally-Enhanced Stepped Care group will receive a download code to download the Moodivate mobile application. Moodivate is a mobile app for individuals with elevated symptoms of depression. Within the app, users identify values, create activities, schedule activities, and rate mood daily. Participants will be asked to complete questionnaire measures at baseline and weeks 1, 2, 4, 6, 8, and 12. App engagement will be passively monitored for two weeks following initial download to determine whether care needs to be stepped up to guideline-concordant standard care.
  • Experimental: Moodivate Only
    Participants randomized to the Moodivate condition will be instructed to utilize Moodivate regularly, at least once per day, for the treatment of depressed mood. Participants in the Moodivate group will receive a download code to download the Moodivate mobile application. Moodivate is a mobile app for individuals with elevated symptoms of depression. Within the app, users identify values, create activities, schedule activities, and rate mood daily. Participants will be asked to complete questionnaire measures at baseline and weeks 1, 2, 4, 6, 8, and 12.
  • Active Comparator: Telebehavioral Health
    Participants randomized to the Telebehavioral Health condition will receive 8 sessions of telehealth-delivered Behavioral Activation therapy with a mental health provider over a 10 week period. Participants will be asked to complete questionnaire measures at baseline and weeks 1, 2, 4, 6, 8, and 10.

Primary Outcome Measure

Feasibility of Digitally Enhanced Stepped-Care [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425-

Find similar trials in Charleston, SC

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Medical University of South Carolina· Charleston, SC

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