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Clinical Trials/NCT05837351
NCT05837351CompletedNot Applicable

The CARE Project: Collaborative Adolescent Running Experience

University of Michigan1 site in 1 country4 target enrollmentStarted: December 5, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
4
Locations
1
Primary Endpoint
The number of completed running sessions

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
13 Years to 17 Years (Child)
Sex
All
Accepts 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

Arms & Interventions

Exercise -Running

Experimental

Intervention: Exercise -Running (Behavioral)

Outcomes

Primary Outcomes

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

  • Change in depression severity as reported by The Patient Health Questionnaire for Adolescents (PHQ-A)(Baseline (prior to treatment), 8 weeks (post intervention))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Richard Dopp

Associate Professor of Psychiatry

University of Michigan

Study Sites (1)

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