Digital Behavioral Activation for Depression

(GetActivE Trial)

Recruiting at 1 trial location

Overseen By Morgan Rose, BS

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pittsburgh

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jamie Zelazny, PhD, MPH, RN

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for at-risk youth dealing with depression and anhedonia, which means they struggle to feel pleasure in normally enjoyable activities. Participants should be interested in using a digital app and engaging with health coaches to manage their symptoms. Specific eligibility criteria are not provided, but typically these would include age range, mental health status, and willingness to use technology.

Inclusion Criteria

Willing to download the app on their smartphones

English language fluency and literacy level sufficient to engage in study protocol

I am between 12 and 18 years old.

Exclusion Criteria

Evidence of mania, psychosis, or developmental disability precluding comprehension of study procedures per EHR review and phone screen.

Treatment Details

Interventions

• GET ActivE (Behavioral Intervention)

Trial Overview The study tests whether a mobile app called Vira combined with health coaching (GET ActivE) can increase enjoyment of life among teens with depression compared to just using another app called EARS. The GET ActivE intervention includes daily interactions with the Vira app and regular conversations with a health coach aimed at improving well-being.

Participant Groups

Group I: GET ActivE Experimental Treatment 1 Intervention

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.

Group II: Activity Monitoring Alone Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

University of Oregon

Collaborator

Trials

91

Recruited

46,700+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+