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Examining the Effects of a Team-based Running Program

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ClinicalTrials.gov Identifier: NCT03143582
Recruitment Status : Active, not recruiting
First Posted : May 8, 2017
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Juliana Tobon, St. Joseph's Healthcare Hamilton

Brief 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.

Condition or disease Intervention/treatment Phase
Memory Learning Mood Attention Stress Sleep Other: Running Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is an open-label pilot study examining the effects of exercise on mood, learning, memory, attention, stress, and sleeping habits.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Examining the Effects of a Team-based Running Program on the Mental Health and Cognition of Emerging Adults: A Pilot Study
Actual Study Start Date : January 31, 2017
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

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 Name: Exercise




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy enough to participate in physical activity

Exclusion Criteria:

  • NOT excluded on basis of mental health or addiction concerns

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143582


Locations
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Canada, Ontario
Youth Wellness Centre
Hamilton, Ontario, Canada, L8P 4W6
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Investigators
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Principal Investigator: Juliana Tobon, PhD, CPsych St. Joseph's Research Institute - Youth Wellness Centre

Additional Information:
Publications:
RiskAnalytica. The life and economic impact of major mental illnesses in canada. Mental Health Commission of Canada. 2011:2011-2041.
Anderson RJ, Brice S. The mood-enhancing benefits of exercise: Memory biases augment the effect. Psychology of Sport & Exercise. 2011;12(2):79-82. doi: 10.1016/j.psychsport.2010.08.003.
van Oers HM. Exercise effects on mood in breast cancer patients. South African Journal of Sports Medicine. 2013;25(2):55. doi: 10.7196/SAJSM.481.
Quelhas Martins A, Kavussanu M, Willoughby A, Ring C. Moderate intensity exercise facilitates working memory. Psychology of Sport and Exercise. 2013;14(3):323-328. doi: 10.1016/j.psychsport.2012.11.010
Dal Grande E, Taylor A, Wilson D. South australian health and wellbeing survey, december 2000. Centre for Population Studies in Epidemiology. 2002.
Rosenberg M. Society and the adolescent self-image. Princeton, NJ: Univ. Press; 1965.
Bagley C, Bolitho F, Bertrand L. Norms and construct validity of the rosenberg self-esteem scale in canadian high school populations: Implications for counselling. Canadian Journal of Counselling. 1997;31(1):82.
Zimet GD, Dahlem NW, Zimet SG, Farley GK. The multidimensional scale of perceived social support. Journal of Personality Assessment. 1988;52(1):30-41. Accessed Dec 2, 2016. doi: 10.1207/s15327752jpa5201_2.
Michael E. Sobel. Asymptotic confidence intervals for indirect effects in structural equation models. Sociological Methodology. 1982;13:290-312.

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Responsible Party: Juliana Tobon, Psychologist, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT03143582     History of Changes
Other Study ID Numbers: 2785
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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