Get ActivE Study for At-risk Youth

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorUniversity of Pittsburgh

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • GET ActivE
  • Treatment As Usual

Treatment groups

75 Participants
are divided into 2 treatment groups

Locations

2
Children's Hospital of Philadelphia19104, PhiladelphiaPennsylvania, United States
University of Pittsburgh Medical Center15213, PittsburghPennsylvania, United States

Sponsors and collaborators

University of Pittsburgh

Lead sponsor

Children's Hospital of Philadelphia

Collaborator

University of Oregon

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

Columbia University

Collaborator