The CARE (Collaborative Adolescent Running Experience) Project

Depression Clinical Trial

— CARE  

Official title:

The CARE Project: Collaborative Adolescent Running Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05837351
• Other study ID #: HUM00212052
• Status: Completed
• Phase: N/A
• Start date: December 5, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: June 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in depression severity as reported by The Patient Health Questionnaire for Adolescents (PHQ-A)	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.	Baseline (prior to treatment), 8 weeks (post intervention)