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NCT07634705 · ClinicalTrials.gov registry record · NA
Digitally Enhanced Stepped-Care for Depression in Primary Care
A NA study, sponsored by Medical University of South Carolina.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT07634705: Recruiting NA study, sponsored by Medical University of South Carolina.
NCT07634705 is a NA study that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07634705, a NA study, is actively recruiting participants, sponsored by Medical University of South Carolina.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
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.
Primary Outcome
We operationalize feasibility as continued engagement after stepping, defined as either using Moodivate at least once per week for \>4 weeks (for engagers) or attending \>4 telebehavioral health sessions (for non-engagers). We selected 4 treatment sessions as meaningful engagement because all BA concepts are introduced to patients within sessions 1-4, and sessions 5-8 primarily reinforce previous concepts. Because a strength of self-guided DMHIs is highly flexible pacing, we opt to base meaningf
Interventions
- BEHAVIORAL Behavioral Activation Therapy App
- BEHAVIORAL Telehealth Delivered Behavioral Activation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-07-02 |
| Est. Completion | 2027-06 |
| Phase | NA |
What NCT07634705 shows while recruiting
NCT07634705 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Behavioral Activation Therapy App is the first listed.
NCT07634705 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07634705 about?
NCT07634705 is a clinical study titled "Digitally Enhanced Stepped-Care for Depression in Primary Care". 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 Ac...
What is the current status of trial NCT07634705?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2026-07-02. Estimated completion is 2027-06.
What interventions are being tested in trial NCT07634705?
The interventions under investigation include: Behavioral Activation Therapy App (BEHAVIORAL), Telehealth Delivered Behavioral Activation (BEHAVIORAL).
Who is sponsoring clinical trial NCT07634705?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07634705's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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