Clinical trial Recruiting at 2 sites Interventional Ages 12 to 18

Digital Behavioral Activation for At-risk Youth

Official title: Geospatial and Ecological Momentary Assessment Technology and Activity Engagement for At-risk Youth (Get ActivE)

Run by University of Pittsburgh · NCT06829953 · Data updated 2026-11-12

This study is testing a new app called Vira, along with help from health coaches, to see if it can encourage at-risk teens to engage in positive activities and improve their mood and mental health.

Quick facts

Study typeInterventional
Ages12 Years to 18 Years
SexAll
Enrollment75 (estimated)
SponsorUniversity of Pittsburgh
Academic / other
Locations2 sites (Philadelphia, Pennsylvania and 1 other locations)
StatusRecruiting
StartedMarch 27, 2025
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedJune 4, 2026
Trial IDNCT06829953 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adolescents aged 12-18 who are experiencing moderate to severe depression and clinically significant anhedonia.

Probably not a fit

Patients with evidence of mania, psychosis, or developmental disabilities that hinder comprehension of study procedures will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to implement a digital Behavioral Activation app called Vira, combined with support from health coaches, to encourage at-risk youth to engage in positive activities. Participants will be randomly assigned to either the GET ActivE intervention or an Activity Monitoring Alone group. The study will assess the feasibility, acceptability, and effectiveness of the intervention in improving anhedonia, depression severity, and reducing suicidal risk among adolescents aged 12-18. The research will also focus on ensuring equitable outcomes across different racial groups.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the risk of suicide and improve mental health outcomes for at-risk youth.

How similar studies have gone: Other studies have shown promise with similar digital behavioral interventions, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania, United States
    Recruiting
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania, United States
    Recruiting

Study contacts

  • Principal investigator: Jamie Zelazny, PhD, MPH, RN — University of Pittsburgh
  • Study coordinator: Brandie George-Milford, MA
  • Email: georgeba2@upmc.edu
  • Phone: 412-246-5629

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.