The CARE (Collaborative Adolescent Running Experience) Project

Not Applicable

Completed

• Conditions: Depression; Bipolar Disorder; Anxiety; Major Depressive Disorder
• Interventions: Behavioral: Exercise -Running

• Registration Number: NCT05837351
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-19
• Study First Submitted QC: 2023-04-19
• Study First Posted: 2023-05-01
• Study Start: 2023-12-05
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise -Running	Exercise -Running	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in depression severity as reported by The Patient Health Questionnaire for Adolescents (PHQ-A)	Baseline (prior to treatment), 8 weeks (post intervention)	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States