Examining the Effects of a Team-based Running Program

April 18, 2020 updated by: Juliana Tobon, St. Joseph's Healthcare Hamilton

Examining the Effects of a Team-based Running Program on the Mental Health and Cognition of Emerging Adults: A Pilot Study

The investigators are interested in finding accessible interventions for youth and young adults that help promote long-term positive mental health functioning. They will be investigating the effects of Team Unbreakable, a 13-week, twice weekly running group, on mental health symptoms, memory, and attention. This intervention will hopefully improve mental health functioning in youth aged 17-25 that are at high risk of developing mental health disorders. Sessions will consist of 30 minutes of running under the supervision of group leaders and coaches. The group will steadily increase the distance and time spent running versus walking, with the goal of having everyone run a 5 km race together at the end of 13 weeks. Once a week, youth will be provided with education on a variety of topics related to health and running. Youth will complete measures before, during, and after the program to assess outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8P 4W6
        • Youth Wellness Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy enough to participate in physical activity

Exclusion Criteria:

  • NOT excluded on basis of mental health or addiction concerns

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Running group
13 week, bi-weekly running group
Other: Running
A 13-week running program where youth run for 30 minutes twice weekly.
Other Names:
  • Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire 9 (PHQ-9)
Time Frame: Starting 1 month to 2 weeks prior to group. Administered on a bi-weekly schedule ending 6 months after the conclusion of the running group.
Nine-item self-report measure designed to monitor the severity of depressive symptoms using the diagnostic criteria found in the DSM-IV
Starting 1 month to 2 weeks prior to group. Administered on a bi-weekly schedule ending 6 months after the conclusion of the running group.
Generalized Anxiety Disorder 7 (GAD-7)
Time Frame: Starting 1 month to 2 weeks prior to group. Administered on a bi-weekly schedule ending 6 months after the conclusion of the running group.
Seven-item self-report anxiety questionnaire designed to monitor and assess the severity of generalized anxiety disorder (GAD) symptoms, using the prominent diagnostic features found in the DSM-IV
Starting 1 month to 2 weeks prior to group. Administered on a bi-weekly schedule ending 6 months after the conclusion of the running group.
Kessler Psychological Distress Scale (K-10)
Time Frame: Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.
Ten-item self-report measure of global psychological distress
Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD Checklist for DSM-V (PCL-5)
Time Frame: Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.
Twenty-item self-report measure of PTSD based on the DSM-V diagnostic criteria
Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.
Rosenberg Self-Esteem Scale (RSES)
Time Frame: Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.
Ten-item self-report measure of global feelings of self-worth
Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.
Multidimensional Scale of Perceived Social Support
Time Frame: Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.
Twelve-item self-report measure of perceived support from three sources: Family, friends, and a significant other
Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.
Work and Social Adjustment Scale (WSAS)
Time Frame: Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.
Five-item self-report measure of impairment in functioning
Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.
Physical Activity and Sleep
Time Frame: Starting 1 month to 2 weeks prior to group auto-recorded ending 6 months after the conclusion of the running group.
Participants will use a Fitbit to monitor their overall activity (e.g., steps, distance, active minutes, etc.) and sleep patterns before, during, and after treatment
Starting 1 month to 2 weeks prior to group auto-recorded ending 6 months after the conclusion of the running group.
Delis-Kramer Executive Function Tower Task
Time Frame: At baseline and 1-week after exercise program ends.
Assesses spatial planning, rule learning, and response inhibition
At baseline and 1-week after exercise program ends.
Hopkins Verbal Learning Task
Time Frame: At baseline and 1-week after exercise program ends.
Tests participants' memory for a list of 12 nouns drawn from 3 categories, and measures immediate and delayed recall and recognition
At baseline and 1-week after exercise program ends.
N-back
Time Frame: At baseline and 1-week after exercise program ends.
A test of executive function (working memory), requiring the participant to observe a sequence of items and click on targets that are repeats n items ago
At baseline and 1-week after exercise program ends.
Concentration Memory Task
Time Frame: At baseline and 1-week after running program ends.
A test of high interference spatial memory. Participants search for pairs of matching cards and are periodically tested on which of two locations an item appeared in most recently
At baseline and 1-week after running program ends.
Town Square
Time Frame: At baseline and 1-week after running program ends.
A test of viewpoint-dependent and -independent spatial memory for a set of visually presented items in a town square
At baseline and 1-week after running program ends.
Wechsler Test of Adult Reading
Time Frame: At baseline
A test to assess pre-morbid intellectual functioning by having the participants verbally speak a list of 50 irregular words
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph's Healthcare Hamilton

Investigators

  • Principal Investigator: Juliana Tobon, PhD, CPsych, St. Joseph's Research Institute - Youth Wellness Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2017

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

November 30, 2018

Study Registration Dates

First Submitted

April 28, 2017

First Submitted That Met QC Criteria

May 3, 2017

First Posted (Actual)

May 8, 2017

Study Record Updates

Last Update Posted (Actual)

April 21, 2020

Last Update Submitted That Met QC Criteria

April 18, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2785

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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