Get ActivE Study for At-risk Youth

Last updated: April 2, 2025
Sponsor: University of Pittsburgh
Overall Status: Active - Recruiting

Phase

N/A

Condition

Suicide

Treatment

GET ActivE

Treatment As Usual

Clinical Study ID

NCT06829953
STUDY22040034
P50MH115838
  • Ages 12-18
  • All Genders

Study 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

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 itemscore > 1

  • English language fluency and literacy level sufficient to engage in study protocol

  • Willing to download the app on their smart phones

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 75
Treatment Group(s): 2
Primary Treatment: GET ActivE
Phase:
Study Start date:
March 27, 2025
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

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