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Digitally Enhanced Stepped-Care for Depression in Primary Care

Digitally Enhanced Stepped-Care for Depression in Primary Care: A Pilot Randomized Clinical Trial to Support Scalable Deployment and Commercialization

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests depression care that starts with Moodivate, a self-guided phone app, and may add video therapy after 2 weeks. It compares this approach with video therapy alone and the app alone to see if people keep using treatment and if symptoms improve. It is for adults with depression symptoms who live in South Carolina and is run through MUSC primary care clinics.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Score of 10 or higher on the PHQ-9, a questionnaire about depression symptoms.
  • Own an iPhone or Android smartphone.
  • Willing to use the Moodivate app.
  • Willing to receive depression care through telehealth, or remote visits.
  • Have access to email or text messages for study questionnaires.
  • Fluent in English.

Who can't join

  • Currently getting talk therapy for depression, such as individual or group therapy.
  • Report thoughts of death or self-harm on the PHQ-9 at least “several days.”
  • Do not live in South Carolina.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

SC