NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Medical University of South Carolina
Conditions: Depression
Interventions: Behavioral Activation Therapy App, Telehealth Delivered Behavioral Activation
Countries: United States
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: Yes
Study type: INTERVENTIONAL
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- Charleston, South Carolina, United States