RecruitingNot ApplicableNCT06829953

Get ActivE Study for At-risk Youth

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


Sponsor

University of Pittsburgh

Enrollment

75 participants

Start Date

Mar 27, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 YearsMax Age: 18 Years

Inclusion Criteria5

  • 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 Criteria1

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

Interventions

BEHAVIORALGET 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.

BEHAVIORALTreatment 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.


Locations(2)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

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NCT06829953


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