Examining the Effects of a Team-based Running Program

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143582
• Other study ID #: 2785
• Status: Completed
• Phase: N/A
• Start date: January 31, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: April 2020
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 25 Years

Eligibility

Inclusion Criteria:

• Healthy enough to participate in physical activity

Exclusion Criteria:

• NOT excluded on basis of mental health or addiction concerns

Related Conditions & MeSH terms

• Attention
• Learning
• Memory
• Mood
• Sleep
• Stress

Intervention

Other:
• Running
A 13-week running program where youth run for 30 minutes twice weekly.

Locations

Country	Name	City	State
Canada	Youth Wellness Centre	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire 9 (PHQ-9)	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.
Primary	Generalized Anxiety Disorder 7 (GAD-7)	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.
Primary	Kessler Psychological Distress Scale (K-10)	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	PTSD Checklist for DSM-V (PCL-5)	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.
Secondary	Rosenberg Self-Esteem Scale (RSES)	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.
Secondary	Multidimensional Scale of Perceived Social Support	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.
Secondary	Work and Social Adjustment Scale (WSAS)	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.
Secondary	Physical Activity and Sleep	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.
Secondary	Delis-Kramer Executive Function Tower Task	Assesses spatial planning, rule learning, and response inhibition	At baseline and 1-week after exercise program ends.
Secondary	Hopkins Verbal Learning Task	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.
Secondary	N-back	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.
Secondary	Concentration Memory Task	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.
Secondary	Town Square	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.
Secondary	Wechsler Test of Adult Reading	A test to assess pre-morbid intellectual functioning by having the participants verbally speak a list of 50 irregular words	At baseline

External Links

•   Fast facts about mental illness.
•   Greenspace Mental Health Ltd.
•   Mental and substance use disorders in canada.
•   PTSD checklist for DSM-5 (PCL-5) made available from the National Center for PTSD.