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The CARE (Collaborative Adolescent Running Experience) Project

The CARE Project: Collaborative Adolescent Running Experience

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05837351
Acronym
CARE
Enrollment
4
Registered
2023-05-01
Start date
2023-12-05
Completion date
2024-04-30
Last updated
2024-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Bipolar Disorder, Depression, Major Depressive Disorder

Keywords

Running, Adolescents

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.

Interventions

BEHAVIORALExercise -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.

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The number of completed running sessionsweeks 1-8 during treatment periodFeasibility and acceptability of the study will be the completion of running sessions based on the Fitbit and or self-report.

Secondary

MeasureTime frameDescription
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026