Get ActivE Study for At-risk Youth

Not Applicable

Recruiting

• Conditions: Anhedonia; Depression and Suicide Ideation

• Registration Number: NCT06829953
• Lead Sponsor: University of Pittsburgh

Brief Summary

The study will adapt and deploy a digital Behavioral Activation app with mobile sensing, supported by health coaches, that encourages youth to engage in positive activities. The study has the potential to offer a low-cost and scalable behavioral intervention that may decrease risk of suicide among at-risk youth. This research will examine specifically whether an intervention involving an app called Vira, combined with health coaching (GET ActivE) can improve enjoyment for teens coping with depression. Research participants will be randomly assigned to one of two study intervention. One study intervention involves a) downloading an app called Vira and engaging by responding to a daily question, and b) participating in a conversation via text, phone, or messages through an appt with a health coach. The health coach will use the Vira app and principles from evidence-based therapy and behavior change to provide users with insights to sustain well-being and better manage risk factors for suicidal thoughts and behaviors such as depressed mood and behavioral withdrawal. The second study intervention involves downloading an app called EARS and responding to a daily question.

Detailed Description

Aim 3 (Randomized Pilot): To examine implementation outcomes, initial effectiveness, and equity across outcomes in a pilot randomized trial (n=75, 2:1 randomization, 35% Black, 10% Hispanic) of GET ActivE vs. Activity Monitoring Alone. H3a. The study will observe high GET ActivE feasibility (50% of eligible youth approached will enroll; completion \>50%; attrition \<20%; response to health coach contacts \>80%); acceptability (\>80%); and appropriateness (\>80%). H3b. Youth who receive GET ActivE will show greater improvement in anhedonia (primary outcome) and H3c. depression severity and suicidal risk (secondary outcomes). H3d. Outcomes will be equitable by race. H3e. Exploratory (mechanistic): GET ActivE will lead to decreased depression and suicidal risk through increased activity and reward responsiveness.

Study Timeline

• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-11
• Study First Posted: 2025-02-17
• Study Start: 2025-03-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Adolescents age 12-18
• Current moderate to severe depression (PHQ-9-M > 11)
• Current clinically significant anhedonia, operationalized as PHQ-9-M anhedonia item score > 1
• English language fluency and literacy level sufficient to engage in study protocol
• Willing to download the app on their smart phones

Exclusion Criteria

• Evidence of mania, psychosis, or developmental disability precluding comprehension of study procedures per electronic health record review and phone screen.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
GET ActivE Feasibility	3 months	The study will observe high GET ActivE intervention feasibility (50% of eligible youth approached will enroll; completion \>50%; attrition \<20%)
Response to Health coach contacts	3 months	Participants will respond to health coach contacts \>80%
GET ActivE Acceptability	Post intervention follow up; up to 3 months	Acceptability of the GET ActivE intervention will be assessed through the 4 item Acceptability of Intervention Measure (AIM). Individual item scores are summed. Scale values range from 1 to 5. No items are reverse scored. Higher scores indicate greater acceptability. The items include questions to determine if intervention is appealing to, liked by, welcomed by, and approved by study population.
GET ActivE Appropriateness	Post intervention follow up; up to 3 months	Intervention appropriateness of the GET ActivE intervention will be assessed through 4 item Intervention Appropriateness Measure (IAM). Individual item scores are summed. Scale values range from 1 to 5. No items are reverse scored. Higher scores indicate greater appropriateness. The items include questions to determine if intervention is a good match, fitting, suitable, or seems applicable to the study population.

Secondary Outcome Measures

Name	Time	Method
Anhedonia	baseline and follow up timepoints 1 month, 3 months, 6 months, 12 months	Anhedonia will be assessed using the self-reported Behavioral Avoidance/Inhibition (BIS/BAS), 24 item scale. The scoring ranges from 1-4 and response options include: Very true for me (1); somewhat true for me (2); somewhat false for me (3); very false for me (4). Total range of scores possible is 24-96. The lower the score reported on BIS/BAS, the less pleasure or enjoyment a responder feels and more anhedonic symptoms are expressed.

Trial Locations

Locations (2)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States