Digitally Enhanced Stepped-Care for Depression in Primary Care

NCT07634705 | Not Yet Recruiting DMC

• 1 other identifier: Pro00150034
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

• Change Over Time in Depression Severity

  12 weeks

Study Arms (3)

Digitally-Enhanced Stepped Care

EXPERIMENTAL

Participants randomized to the Digitally-Enhanced Stepped Care condition will be instructed to utilize a Behavioral Activation therapy focused mobile application called "Moodivate" regularly, at least once per day, for the treatment of depressed mood among cancer survivors. Participants in the Digitally-Enhanced Stepped Care group will receive a download code to download the Moodivate mobile application. Moodivate is a mobile app for individuals with elevated symptoms of depression. Within the app, users identify values, create activities, schedule activities, and rate mood daily. Participants will be asked to complete questionnaire measures at baseline and weeks 1, 2, 4, 6, 8, and 12. App engagement will be passively monitored for two weeks following initial download to determine whether care needs to be stepped up to guideline-concordant standard care.

Behavioral: Behavioral Activation Therapy App

Moodivate Only

EXPERIMENTAL

Participants randomized to the Moodivate condition will be instructed to utilize Moodivate regularly, at least once per day, for the treatment of depressed mood. Participants in the Moodivate group will receive a download code to download the Moodivate mobile application. Moodivate is a mobile app for individuals with elevated symptoms of depression. Within the app, users identify values, create activities, schedule activities, and rate mood daily. Participants will be asked to complete questionnaire measures at baseline and weeks 1, 2, 4, 6, 8, and 12.

Behavioral: Behavioral Activation Therapy App

Telebehavioral Health

ACTIVE COMPARATOR

Participants randomized to the Telebehavioral Health condition will receive 8 sessions of telehealth-delivered Behavioral Activation therapy with a mental health provider over a 10 week period. Participants will be asked to complete questionnaire measures at baseline and weeks 1, 2, 4, 6, 8, and 10.

Behavioral: Telehealth Delivered Behavioral Activation

Interventions

Behavioral Activation Therapy App BEHAVIORAL

Moodivate focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood. Participants will be asked to complete questionnaire measures at baseline and weeks 1, 2, 4, 6, 8, and 12.

Digitally-Enhanced Stepped Care; Moodivate Only

Telehealth Delivered Behavioral Activation BEHAVIORAL

8 sessions of telehealth-delivered Behavioral Activation with a mental health provider over a 10-week period.

Telebehavioral Health

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jennifer Dahne, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noelle Natale

CONTACT

843-876-9457; natalen@musc.edu

McKay Lucas

CONTACT

843-876-2611; lucasmc@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

US (1)