The CARE (Collaborative Adolescent Running Experience) Project

Sponsor

University of Michigan (Other)

Overall Status

Recruiting

CT.gov ID

NCT05837351

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Anxiety Major Depressive Disorder Bipolar Disorder	Behavioral: Exercise -Running	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The CARE Project: Collaborative Adolescent Running Experience

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise -Running	Behavioral: Exercise -Running 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.

Arm

Intervention/Treatment

Experimental: Exercise -Running

Behavioral: Exercise -Running

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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