Digitally Enhanced Stepped-Care for Depression in Primary Care

This pilot, three‐arm randomized clinical trial (N=40; 2:1:1) will evaluate thefeasibility and preliminary efficacy of a digitally enhanced stepped‐care approach fordepression treatment in primary care. Participants will be randomized to: (1)stepped‐care beginning with a self‐guided Behavioral Activation app (Moodivate), withstepping to clinician‐delivered telebehavioral health Behavioral Activation at Week 2based on app engagement and early PHQ‐9 change; (2) telebehavioral health BehavioralActivation; or (3) Moodivate alone. The primary endpoint is feasibility of thestepped‐care approach, defined as continued engagement after stepping (≥1 Moodivateuse/week for >4 weeks or ≥4 therapy sessions). The secondary endpoint is change in PHQ‐9scores from baseline through Week 12. The study will be conducted within MUSC PrimaryCare clinics across South Carolina using remote screening, e‐consent, and REDCapassessments.