Digitally Enhanced Stepped-Care for Depression in Primary Care

Medical University of South Carolina40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depression

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Feasibility of Digitally Enhanced Stepped-Care

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 meaningful DMHI engagement on continued app use over time, for a duration of \>4 weeks to be comparable to the BA feasibility benchmark. Digitally enhanced stepped-care will be considered feasible if \>75% of participants meet these feasibility benchmarks.

Time frame: 12 weeks

Secondary Outcomes

Change Over Time in Depression Severity

Depression will be assessed via the PHQ-9 at baseline and all follow-ups. The PHQ-9 has high sensitivity and specificity for identifying depression.