Get ActivE Study for At-risk Youth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GET ActivE, Treatment As Usual.
- Who it may be relevant to
- Registry conditions: Anhedonia, Depression and Suicide Ideation. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Geospatial and Ecological Momentary Assessment Technology and Activity Engagement for At-risk Youth (Get ActivE)
Overview
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.
Detailed 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.
Interventions
- Behavioral GET 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. - Behavioral Treatment 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.
Primary outcome measures
- GET ActivE Feasibility [Time frame: 3 months]
- Response to Health coach contacts [Time frame: 3 months]
- GET ActivE Acceptability [Time frame: Post intervention follow up; up to 3 months]
- GET ActivE Appropriateness [Time frame: Post intervention follow up; up to 3 months]
Secondary outcome measures (1)
- Anhedonia [Time frame: baseline and follow up timepoints 1 month, 3 months, 6 months, 12 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Children's Hospital of Philadelphia — Philadelphia
- University of Pittsburgh Medical Center — Pittsburgh
Identifiers
NCT: NCT06829953 · STUDY22040034 · P50MH115838