Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
75 participants
INTERVENTIONAL
2025-03-27
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
12 Years
18 Years
ALL
No
Sponsors
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Children's Hospital of Philadelphia
OTHER
University of Oregon
OTHER
National Institute of Mental Health (NIMH)
NIH
Columbia University
OTHER
University of Pittsburgh
OTHER
Responsible Party
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Jamie Zelazny
Assistant Professor
Principal Investigators
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Jamie Zelazny, PhD, MPH, RN
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY22040034
Identifier Type: -
Identifier Source: org_study_id
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