Digital Behavioral Activation for At-risk Youth
Geospatial and Ecological Momentary Assessment Technology and Activity Engagement for At-risk Youth (Get ActivE)
NA · University of Pittsburgh · NCT06829953
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | University of Pittsburgh (other) |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Trial ID | NCT06829953 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12-18 who are experiencing moderate to severe depression and clinically significant anhedonia.
Not a fit: Patients with evidence of mania, psychosis, or developmental disabilities that hinder comprehension of study procedures will not benefit from this study.
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 performed: Other studies have shown promise with similar digital behavioral interventions, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Philadelphia, Pennsylvania and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anhedonia, Depression and Suicide Ideation, Behavioral Activation, Health Coach, Minority Youth, Suicide