Get ActivE Study for At-risk Youth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorUniversity of Pittsburgh
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Evidence of mania, psychosis, or developmental disability precluding comprehension of study procedures per electronic health record review and phone screen.
Trial design
Design model
Parallel
Treatments tested in this trial
GET ActivE
BehavioralThe 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
BehavioralParticipants 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.
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: Activity Monitoring AloneActive comparator 1 intervention
Group B: GET ActivEExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
GET ActivE Feasibility
The study will observe high GET ActivE intervention feasibility (50% of eligible youth approached will enroll; completion \>50%; attrition \<20%)
Time frame
3 months2
Response to Health coach contacts
Participants will respond to health coach contacts \>80%
Time frame
3 months3
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.
Time frame
Post intervention follow up; up to 3 months4
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.
Time frame
Post intervention follow up; up to 3 monthsSecondary outcomes
1
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.
Time frame
baseline and follow up timepoints 1 month, 3 months, 6 months, 12 monthsOther outcomes
1
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.
Time frame
baseline and follow up timepoints 1 month, 3 months, 6 months, 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
Children's Hospital of Philadelphia
Collaborator
University of Oregon
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Columbia University
Collaborator
Source ClinicalTrials.gov