NCT06829953 · University of Pittsburgh
Get ActivE Study for At-risk Youth
(GetActivE)
What this study is about
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.
View original scientific description
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.
Interventions
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.
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.
Primary outcome measures
GET ActivE Feasibility
Time frame: 3 months
The study will observe high GET ActivE intervention feasibility (50% of eligible youth approached will enroll; completion \>50%; attrition \<20%)
Response to Health coach contacts
Time frame: 3 months
Participants will respond to health coach contacts \>80%
GET ActivE Acceptability
Time frame: Post intervention follow up; up to 3 months
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.
GET ActivE Appropriateness
Time frame: Post intervention follow up; up to 3 months
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
Collaborators
Children's Hospital of Philadelphia, University of Oregon, National Institute of Mental Health (NIMH), Columbia University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations