Get ActivE Study for At-risk Youth

Recruiting · NCT06829953 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Pittsburgh

View the official record on ClinicalTrials.gov →

Depression

Interventions studied

GET ActivETreatment As Usual

What this trial is about

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.

Who can take part

Age range

12 Years to 18 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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 is running

2 locations listed across 1 US state.

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

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →