Get ActivE Study for At-risk Youth
Purpose
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.
Conditions
- Anhedonia
- Depression and Suicide Ideation
Eligibility
- Eligible Ages
- Between 12 Years and 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- 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
- Masking
- Single (Outcomes Assessor)
- Masking Description
- The outcomes assessor will be blinded to the randomized treatment arm
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Activity Monitoring Alone |
Participants who are eligible for the GET Active Study and are randomly assigned to Treatment As Usual will be asked to download a mobile sensing activity monitoring app called the Effortless Assessment of Risk States (EARS) app which will derive activity data. The activity data will be collated to yield weekly summary measures that will be sent via short messaging services (SMS) text messaging to participants randomized to the control condition for viewing. |
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|
Experimental GET ActivE |
GET ActivE intervention uses the Vira mobile application and a health coach, integrating mobile sensing, self-report assessment, and just-in-time nudges and notifications from a health coach to increase patient activity and promote positive mood cycles. A health coach reinforces Behavioral Activation (BA) principles and encourages engagement with activities by composing and triggering appropriate intervention nudges and messages (by text, phone call, video call, chat, email, etc.) specific to activity patterns and mood ratings highlighted on the Vira app. The health coach reviews the patient's data from the Vira practitioner dashboard and will follow up with patients at least weekly (and caregivers periodically) to reinforce behaviors that are consistent with BA and personally relevant based on the participant's own mobile sensing data and mood ratings. |
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Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of Pittsburgh
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.
