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Recruiting NCT06829953

NCT06829953 Get ActivE Study for At-risk Youth

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Clinical Trial Summary
NCT ID NCT06829953
Status Recruiting
Phase
Sponsor University of Pittsburgh
Condition Anhedonia
Study Type INTERVENTIONAL
Enrollment 75 participants
Start Date 2025-03-27
Primary Completion 2026-12-31

Eligibility & Interventions

Sex All sexes
Min Age 12 Years
Max Age 18 Years
Study Type INTERVENTIONAL
Interventions
GET ActivETreatment As Usual

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 75 participants in total. It began in 2025-03-27 with a primary completion date of 2026-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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.

Contact & Investigator

Central Contact

Brandie George-Milford, MA

✉ georgeba2@upmc.edu

📞 412-246-5629

Principal Investigator

Jamie Zelazny, PhD, MPH, RN

PRINCIPAL INVESTIGATOR

University of Pittsburgh

Frequently Asked Questions

Who can join the NCT06829953 clinical trial?

This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Anhedonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06829953 currently recruiting?

Yes, NCT06829953 is actively recruiting participants. Contact the research team at georgeba2@upmc.edu for enrollment information.

Where is the NCT06829953 trial being conducted?

This trial is being conducted at Philadelphia, United States, Pittsburgh, United States.

Who is sponsoring the NCT06829953 clinical trial?

NCT06829953 is sponsored by University of Pittsburgh. The principal investigator is Jamie Zelazny, PhD, MPH, RN at University of Pittsburgh. The trial plans to enroll 75 participants.

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