Get ActivE Study for At-risk Youth (GetActivE)

University of Pittsburgh

Status: Enrolling

Conditions: Depression and Suicide Ideation; Anhedonia

Treatments: Behavioral: Treatment As Usual; Behavioral: GET ActivE

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06829953

STUDY22040034

P50MH115838 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 2 patient groups

Activity Monitoring Alone

Active Comparator group

Description:

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.

Treatment:

Behavioral: Treatment As Usual

GET ActivE

Experimental group

Description:

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.

Treatment:

Behavioral: GET ActivE