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

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 Overview

• Status: Not yet recruiting
• Conditions: Depression
• Intervention / Treatment: Behavioral: Telehealth Delivered Behavioral Activation; Behavioral: Behavioral Activation Therapy App

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noelle Natale; Phone Number: 843-876-9457; Email: natalen@musc.edu
• Study Contact Backup: Name: McKay Lucas; Phone Number: 843-876-2611; Email: lucasmc@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digitally-Enhanced Stepped Care; 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 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.
Experimental: Moodivate Only; 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; 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.
Active Comparator: Telebehavioral Health; 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; 8 sessions of telehealth-delivered Behavioral Activation with a mental health provider over a 10-week period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Jennifer Dahne, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: Pro00150034

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No