Recruiting

ActivE

Sponsor:

University of Pittsburgh

Code:

NCT06829953

Conditions

Anhedonia

Depression and Suicide Ideation

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

GET ActivE

Treatment As Usual

Study Details

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

Study ID

NCT06829953

Start date

Mar 27, 2025

Status verified date

Jun, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

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

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • GET ActivE Feasibility [ Time Frame: 3 months ]
  • Response to Health coach contacts [ Time Frame: 3 months ]
  • GET ActivE Acceptability [ Time Frame: Post intervention follow up; up to 3 months ]
  • GET ActivE Appropriateness [ Time Frame: Post intervention follow up; up to 3 months ]

Central Contacts and Locations

Central contacts

Brandie George-Milford, MA

412-246-5629georgeba2@upmc.edu

Morgan Rose, BS

978-799-9419rosem5@upmc.edu

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Jami Young, PhD

267-425-1328youngjf@chop.edu

Rhonda Boyd, PhD

215-590-7555boydr@chop.edu

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Jamie Zelazny, PhD

412-624-9647jmz22@pitt.edu

Brandie George-Milford, MA

412-246-5629georgeba2@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-06-04.