Get ActivE Study for At-risk Youth

NCT06829953 | Recruiting DMC

• 2 other identifiers: STUDY22040034P50MH115838
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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.

Conditions

Anhedonia; Depression and Suicide Ideation

Keywords

Behavioral Activation; Health Coach; Anhedonia; Minority Youth; Suicide

Outcome Measures

Primary Outcomes (4)

• GET ActivE Feasibility

  The study will observe high GET ActivE intervention feasibility (50% of eligible youth approached will enroll; completion \>50%; attrition \<20%)

  3 months

• Response to Health coach contacts

  Participants will respond to health coach contacts \>80%

  3 months

• GET ActivE Acceptability

  Acceptability of the GET ActivE intervention will be assessed through the 4 item Acceptability of Intervention Measure (AIM). Individual item scores are summed. Scale values range from 1 to 5. No items are reverse scored. Higher scores indicate greater acceptability. The items include questions to determine if intervention is appealing to, liked by, welcomed by, and approved by study population.

  Post intervention follow up; up to 3 months

• GET ActivE Appropriateness

  Intervention appropriateness of the GET ActivE intervention will be assessed through 4 item Intervention Appropriateness Measure (IAM). Individual item scores are summed. Scale values range from 1 to 5. No items are reverse scored. Higher scores indicate greater appropriateness. The items include questions to determine if intervention is a good match, fitting, suitable, or seems applicable to the study population.

  Post intervention follow up; up to 3 months

Secondary Outcomes (1)

• Anhedonia

  baseline and follow up timepoints 1 month, 3 months, 6 months, 12 months

Other Outcomes (1)

• Suicidal thoughts and behaviors

  baseline and follow up timepoints 1 month, 3 months, 6 months, 12 months

Study Arms (2)

Activity Monitoring Alone

ACTIVE COMPARATOR

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.

Behavioral: Treatment As Usual

GET ActivE

EXPERIMENTAL

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.

Behavioral: GET ActivE

Interventions

GET ActivE BEHAVIORAL

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.

GET ActivE

Treatment As Usual BEHAVIORAL

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.

Activity Monitoring Alone

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Evidence of mania, psychosis, or developmental disability precluding comprehension of study procedures per electronic health record review and phone screen.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Children's Hospital of Philadelphia: collaborator
• University of Oregon: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Columbia University: collaborator

Study Sites (2)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Anhedonia; Depression; Suicide

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Self-Injurious Behavior

Study Officials

• Jamie Zelazny, PhD, MPH, RN

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandie George-Milford, MA

CONTACT

412-246-5629; georgeba2@upmc.edu

Morgan Rose, BS

CONTACT

978-799-9419; rosem5@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded to the randomized treatment arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: March 27, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Individual participant data will be available in a deidentified manner through the NIMH Data Archive indefinitely.
• Access Criteria: Verified researchers may request the data through the NIMH Data Archive.

Locations

US (2)