Skip to main content
OpenTrials
Completed

NCT Number: NCT05837351

The CARE (Collaborative Adolescent Running Experience) Project

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Depressive Disorder, Major Major Depressive Disorder Mental Disorders Mood Disorders

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise -Running

Behavioral

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.

Primary outcomes

  1. The number of completed running sessions

    Time frame: 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 outcomes

  1. Change in depression severity as reported by The Patient Health Questionnaire for Adolescents (PHQ-A)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

The CARE Project: Collaborative Adolescent Running Experience

Acronym: CARE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 1, 2023
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.