The CARE (Collaborative Adolescent Running Experience) Project

NCT ID: NCT05837351

Last Updated: 2024-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-05

Study Completion Date

2024-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Depression Anxiety Major Depressive Disorder Bipolar Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise -Running

Group Type EXPERIMENTAL

Exercise -Running

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Richard Dopp

Associate Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Dopp, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00212052

Identifier Type: -

Identifier Source: org_study_id

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