Clinical trial NCT06829953: Get ActivE Study for At-risk Youth
Official title: Geospatial and Ecological Momentary Assessment Technology and Activity Engagement for At-risk Youth (Get ActivE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anhedonia
Depression and Suicide Ideation
Keywords: Behavioral Activation
Health Coach
Anhedonia
Minority Youth
Suicide
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: University of Oregon
name: National Institute of Mental Health (NIMH)
name: Columbia University
First posted: 2025-02-17
Enrollment: 75
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Examination of implementation outcomes, target engagement, and preliminary effectiveness of GET ActivE via a randomized trial with 75 adolescents (age 12-18, 35% Black, 10% Hispanic) at risk for suicide (moderate-severe depression) and with difficulties with anhedonic symptoms identified in primary care.
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: GET ActivE Feasibility
timeFrame: 3 months
measure: Response to Health coach contacts
timeFrame: 3 months
measure: GET ActivE Acceptability
timeFrame: Post intervention follow up; up to 3 months
measure: GET ActivE Appropriateness
timeFrame: Post intervention follow up; up to 3 months
Secondary outcomes:
measure: Anhedonia
timeFrame: baseline and follow up timepoints 1 month, 3 months, 6 months, 12 months
Other outcomes:
measure: Suicidal thoughts and behaviors
timeFrame: baseline and follow up timepoints 1 month, 3 months, 6 months, 12 months
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jamie Zelazny, PhD, MPH, RN
role: PRINCIPAL_INVESTIGATOR
References: