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The CARE (Collaborative Adolescent Running Experience) Project (CARE)

Primary Purpose

Depression, Anxiety, Major Depressive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise -Running
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Running, Adolescents

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise -Running

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 19, 2023
Last Updated
October 11, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05837351
Brief Title
The CARE (Collaborative Adolescent Running Experience) Project
Acronym
CARE
Official Title
The CARE Project: Collaborative Adolescent Running Experience
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Major Depressive Disorder, Bipolar Disorder
Keywords
Running, Adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise -Running
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Exercise -Running
Intervention Description
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 Outcome Measure Information:
Title
The number of completed running sessions
Description
Feasibility and acceptability of the study will be the completion of running sessions based on the Fitbit and or self-report.
Time Frame
weeks 1-8 during treatment period
Secondary Outcome Measure Information:
Title
Change in depression severity as reported by The Patient Health Questionnaire for Adolescents (PHQ-A)
Description
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.
Time Frame
Baseline (prior to treatment), 8 weeks (post intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Gach
Phone
734-232-2901
Email
ejgach@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Dopp, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Gach
Phone
734-232-2901
Email
ejgach@umich.edu
First Name & Middle Initial & Last Name & Degree
Richard Dopp, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The CARE (Collaborative Adolescent Running Experience) Project

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