Clinical trial NCT03143582: Examining the Effects of a Team-based Running Program
Official title: Examining the Effects of a Team-based Running Program on the Mental Health and Cognition of Emerging Adults: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Memory
Learning
Mood
Attention
Stress
Sleep
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 17
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open-label pilot study examining the effects of exercise on mood, learning, memory, attention, stress, and sleeping habits.
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* Healthy enough to participate in physical activity

Exclusion Criteria:

* NOT excluded on basis of mental health or addiction concerns

Primary outcomes:
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: 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.
measure: Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: 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.
measure: Kessler Psychological Distress Scale (K-10)
timeFrame: 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 outcomes:
measure: PTSD Checklist for DSM-V (PCL-5)
timeFrame: 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.
measure: Rosenberg Self-Esteem Scale (RSES)
timeFrame: 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.
measure: Multidimensional Scale of Perceived Social Support
timeFrame: 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.
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: 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.
measure: Physical Activity and Sleep
timeFrame: Starting 1 month to 2 weeks prior to group auto-recorded ending 6 months after the conclusion of the running group.
measure: Delis-Kramer Executive Function Tower Task
timeFrame: At baseline and 1-week after exercise program ends.
measure: Hopkins Verbal Learning Task
timeFrame: At baseline and 1-week after exercise program ends.
measure: N-back
timeFrame: At baseline and 1-week after exercise program ends.
measure: Concentration Memory Task
timeFrame: At baseline and 1-week after running program ends.
measure: Town Square
timeFrame: At baseline and 1-week after running program ends.
measure: Wechsler Test of Adult Reading
timeFrame: At baseline
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Youth Wellness Centre
state: Ontario
Study officials:
affiliation: St. Joseph's Research Institute - Youth Wellness Centre
name: Juliana Tobon, PhD, CPsych
role: PRINCIPAL_INVESTIGATOR
References:
citation: RiskAnalytica. The life and economic impact of major mental illnesses in canada. Mental Health Commission of Canada. 2011:2011-2041.
citation: Lim KL, Jacobs P, Ohinmaa A, Schopflocher D, Dewa CS. A new population-based measure of the economic burden of mental illness in Canada. Chronic Dis Can. 2008;28(3):92-8.
citation: Merikangas KR, Nakamura EF, Kessler RC. Epidemiology of mental disorders in children and adolescents. Dialogues Clin Neurosci. 2009;11(1):7-20. doi: 10.31887/DCNS.2009.11.1/krmerikangas.
citation: Shapiro CM, Bortz R, Mitchell D, Bartel P, Jooste P. Slow-wave sleep: a recovery period after exercise. Science. 1981 Dec 11;214(4526):1253-4. doi: 10.1126/science.7302594.
citation: Dery N, Pilgrim M, Gibala M, Gillen J, Wojtowicz JM, Macqueen G, Becker S. Adult hippocampal neurogenesis reduces memory interference in humans: opposing effects of aerobic exercise and depression. Front Neurosci. 2013 Apr 30;7:66. doi: 10.3389/fnins.2013.00066. eCollection 2013.
citation: 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.
citation: 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.
citation: Prakash RS, Voss MW, Erickson KI, Lewis JM, Chaddock L, Malkowski E, Alves H, Kim J, Szabo A, White SM, Wojcicki TR, Klamm EL, McAuley E, Kramer AF. Cardiorespiratory fitness and attentional control in the aging brain. Front Hum Neurosci. 2011 Jan 14;4:229. doi: 10.3389/fnhum.2010.00229. eCollection 2011.
citation: Chang YK, Pesce C, Chiang YT, Kuo CY, Fong DY. Antecedent acute cycling exercise affects attention control: an ERP study using attention network test. Front Hum Neurosci. 2015 Apr 9;9:156. doi: 10.3389/fnhum.2015.00156. eCollection 2015.
citation: Monti JM, Hillman CH, Cohen NJ. Aerobic fitness enhances relational memory in preadolescent children: the FITKids randomized control trial. Hippocampus. 2012 Sep;22(9):1876-82. doi: 10.1002/hipo.22023. Epub 2012 Apr 23.
citation: 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
citation: Guiney H, Machado L. Benefits of regular aerobic exercise for executive functioning in healthy populations. Psychon Bull Rev. 2013 Feb;20(1):73-86. doi: 10.3758/s13423-012-0345-4.
citation: Snyder JS, Soumier A, Brewer M, Pickel J, Cameron HA. Adult hippocampal neurogenesis buffers stress responses and depressive behaviour. Nature. 2011 Aug 3;476(7361):458-61. doi: 10.1038/nature10287.
citation: van Praag H, Shubert T, Zhao C, Gage FH. Exercise enhances learning and hippocampal neurogenesis in aged mice. J Neurosci. 2005 Sep 21;25(38):8680-5. doi: 10.1523/JNEUROSCI.1731-05.2005.
citation: Hutton CP, Dery N, Rosa E, Lemon JA, Rollo CD, Boreham DR, Fahnestock M, deCatanzaro D, Wojtowicz JM, Becker S. Synergistic effects of diet and exercise on hippocampal function in chronically stressed mice. Neuroscience. 2015 Nov 12;308:180-93. doi: 10.1016/j.neuroscience.2015.09.005. Epub 2015 Sep 7.
citation: Nuechterlein KH, Dawson ME, Ventura J, Gitlin M, Subotnik KL, Snyder KS, Mintz J, Bartzokis G. The vulnerability/stress model of schizophrenic relapse: a longitudinal study. Acta Psychiatr Scand Suppl. 1994;382:58-64. doi: 10.1111/j.1600-0447.1994.tb05867.x.
citation: Alexander SJ, Harrison AG. Cognitive responses to stress, depression, and anxiety and their relationship to ADHD symptoms in first year psychology students. J Atten Disord. 2013 Jan;17(1):29-37. doi: 10.1177/1087054711413071. Epub 2011 Aug 8.
citation: Sinha R. Modeling stress and drug craving in the laboratory: implications for addiction treatment development. Addict Biol. 2009 Jan;14(1):84-98. doi: 10.1111/j.1369-1600.2008.00134.x. Epub 2008 Oct 20.
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
citation: Gilbody S, Richards D, Brealey S, Hewitt C. Screening for depression in medical settings with the Patient Health Questionnaire (PHQ): a diagnostic meta-analysis. J Gen Intern Med. 2007 Nov;22(11):1596-602. doi: 10.1007/s11606-007-0333-y. Epub 2007 Sep 14.
citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
citation: Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SL, Walters EE, Zaslavsky AM. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med. 2002 Aug;32(6):959-76. doi: 10.1017/s0033291702006074.
citation: Dal Grande E, Taylor A, Wilson D. South australian health and wellbeing survey, december 2000. Centre for Population Studies in Epidemiology. 2002.
citation: Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.
citation: Rosenberg M. Society and the adolescent self-image. Princeton, NJ: Univ. Press; 1965.
citation: 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.
citation: Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095.
citation: Canty-Mitchell J, Zimet GD. Psychometric properties of the Multidimensional Scale of Perceived Social Support in urban adolescents. Am J Community Psychol. 2000 Jun;28(3):391-400. doi: 10.1023/A:1005109522457.
citation: Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
citation: Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986 Dec;51(6):1173-82. doi: 10.1037//0022-3514.51.6.1173.
citation: Michael E. Sobel. Asymptotic confidence intervals for indirect effects in structural equation models. Sociological Methodology. 1982;13:290-312.