The CARE (Collaborative Adolescent Running Experience) Project

NCT05837351 | Completed

• 1 other identifier: HUM00212052
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; Major Depressive Disorder; Bipolar Disorder

Keywords

Running; Adolescents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Baseline (prior to treatment), 8 weeks (post intervention)

Study Arms (1)

Exercise -Running

EXPERIMENTAL

Behavioral: Exercise -Running

Interventions

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.

Exercise -Running

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Depressive Disorder, Major; Bipolar Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Depressive Disorder; Mood Disorders; Bipolar and Related Disorders

Study Officials

• Richard Dopp, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 1, 2023
• Study Start: December 5, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)