Get ActivE Study for At-risk Youth (GetActivE)

Geospatial and Ecological Momentary Assessment Technology and Activity Engagement for At-risk Youth (Get ActivE)

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.

Study Overview

• Status: Recruiting
• Conditions: Anhedonia; Depression and Suicide Ideation
• Intervention / Treatment: Behavioral: Treatment As Usual; Behavioral: GET ActivE

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brandie George-Milford, MA; Phone Number: 412-246-5629; Email: georgeba2@upmc.edu
• Study Contact Backup: Name: Morgan Rose, BS; Phone Number: 978-799-9419; Email: rosem5@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Children's Hospital of Philadelphia
      • Contact: Jami Young, PhD; Phone Number: 267-425-1328; Email: youngjf@chop.edu
      • Contact: Rhonda Boyd, PhD; Phone Number: 215-590-7555; Email: boydr@chop.edu
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh Medical Center
      • Contact: Brandie George-Milford, MA; Phone Number: 412-246-5629; Email: georgeba2@upmc.edu
      • Contact: Jamie Zelazny, PhD; Phone Number: 412-624-9647; Email: jmz22@pitt.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anhedonia	Anhedonia will be assessed using the self-reported Behavioral Avoidance/Inhibition (BIS/BAS), 24 item scale. The scoring ranges from 1-4 and response options include: Very true for me (1); somewhat true for me (2); somewhat false for me (3); very false for me (4). Total range of scores possible is 24-96. The lower the score reported on BIS/BAS, the less pleasure or enjoyment a responder feels and more anhedonic symptoms are expressed.	baseline and follow up timepoints 1 month, 3 months, 6 months, 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suicidal thoughts and behaviors	Suicidal attempt & ideation will be measured through the Columbia Suicide Severity Rating Scale (C-SSRS). Assign score of 0 if no ideation/behavior present and assign a score of 1 if ideation/behavior present. A "yes" answer any time during treatment to any 1 of the 5 suicidal behavior questions (Categories 7-10) on the C-SSRS. C-SSRS Categories 7-10 are as follows: 7-Aborted Attempt 8-Interrupted Attempt 9-Actual Attempt (non-fatal) 10-Completed Suicide. Any score greater than 0 is important/may indicate need for intervention.	baseline and follow up timepoints 1 month, 3 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: University of Oregon; National Institute of Mental Health (NIMH); Children's Hospital of Philadelphia; Columbia University
• Investigators: Principal Investigator: Jamie Zelazny, PhD, MPH, RN, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): February 17, 2025

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Behavioral Activation; Suicide; Anhedonia; Health Coach; Minority Youth
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Behavioral Symptoms; Neurobehavioral Manifestations; Self-Injurious Behavior; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Suicide; Depression; Anhedonia; Therapeutics
• Other Study ID Numbers: STUDY22040034; P50MH115838 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Consistent with the NIMH's data sharing and data use policies this research study and clinical trial will be compliant with requirements for depositing data with the NIMH Data Archive (NDA) in the National Database for Clinical Trials Related to Mental Illness (NDCT). Specific statements will be added to the consent forms to allow for data sharing. The final completely de-identified dataset(s) will include demographic and clinical data at baseline, and primary and secondary outcomes for all studies.
• IPD Sharing Time Frame: Individual participant data will be available in a deidentified manner through the NIMH Data Archive indefinitely.
• IPD Sharing Access Criteria: Verified researchers may request the data through the NIMH Data Archive.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No