The CARE (Collaborative Adolescent Running Experience) Project

Study Overview
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Brief Summary
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This study is being completed to see if participants activity levels may have an impact as a treatment for depression, or depressive symptoms. Eligible participants will be enrolled and have an 8-week running intervention three times each week. The study hypothesizes that adolescents with Psychiatric disorders that are experiencing depressive symptoms will participate in a supported running intervention.

Official Title
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The CARE Project: Collaborative Adolescent Running Experience

Conditions
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Depression, Anxiety, Major Depressive Disorder, Bipolar Disorder

Intervention / Treatment
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* Behavioral: Exercise -Running


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Psychiatric disorders that are experiencing depressive symptoms (defined by the protocol) Must have a smart phone Parents/guardians will be advised to discuss their child's participation in the intervention with the participant's primary care physician Exclusion Criteria: Adolescents with unstable cardiac, pulmonary, endocrine or renal disorders Adolescents with previous injuries or other conditions that may impact the safety of a running intervention

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise -Running<br> | Behavioral: Exercise -Running<br>* At baseline participants will wear a Fitbit for one week and attend the Runner's Assessment. After this the participant will begin to run 3 times per week for eight weeks. Every week, participation in a virtual support group with the physical therapist, research coordinator, and other research staff will be expected. Rest-activity cycles' data will be monitored; if at any point the runner is not able to complete 3 runs per week, participants will be encouraged to contact research staff the issues for this (such as medical problem or scheduling difficulty) and formulate plans to remediate the situation. Participants that would like to continue the treatment for an additional eight weeks will have additional data collected. Participants will also wear the Fitbit through-out the study and complete surveys during the study and have blood drawn.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of completed running sessions | Feasibility and acceptability of the study will be the completion of running sessions based on the Fitbit and or self-report. | weeks 1-8 during treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression severity as reported by The Patient Health Questionnaire for Adolescents (PHQ-A) | This is a self-report questionnaire designed for the purpose of assessing anxiety, mood, eating, and substance use disorders. For the first section (9 questions) the participants will select from Not at all (0) to nearly every day (3). The next section asks if in the past year participants felt depressed or sad most days (yes or no) and if so, not difficult at all to extremely difficult. The last question participants are asked about suicide. Scores of 5, 10, 15, and 20 represent cut points for mild, moderate, moderately severe and severe depression. | Baseline (prior to treatment), 8 weeks (post intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Running, Adolescents