Get ActivE Study for At-risk Youth
NCT06829953 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2026-03-19
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.
Conditions
- Anhedonia
- Depression and Suicide Ideation
Interventions
- BEHAVIORAL
-
GET ActivE
The GET ActivE health coach will review data from the Vira app and send nudges to the participant with insights encouraging them to engage in activities that bring enjoyment or pleasure.
- BEHAVIORAL
-
Treatment As Usual
Participants randomized to Treatment As Usual may have access to activity data from an app and receive summary information about activity patterns at the end of their participation.
Sponsors & Collaborators
-
Children's Hospital of Philadelphia
collaborator OTHER -
University of Oregon
collaborator OTHER -
National Institute of Mental Health (NIMH)
collaborator NIH - collaborator OTHER
-
University of Pittsburgh
lead OTHER
Principal Investigators
-
Jamie Zelazny, PhD, MPH, RN · University of Pittsburgh
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-27
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- United States
Study Locations
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