Examining the Effects of a Team-based Running Program
18 de abril de 2020 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
30
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Ontario
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Hamilton, Ontario, Canadá, L8P 4W6
- Youth Wellness Centre
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
17 anos a 25 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Healthy enough to participate in physical activity
Exclusion Criteria:
- NOT excluded on basis of mental health or addiction concerns
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Running group
13 week, bi-weekly running group
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A 13-week running program where youth run for 30 minutes twice weekly.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Patient Health Questionnaire 9 (PHQ-9)
Prazo: 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.
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Nine-item self-report measure designed to monitor the severity of depressive symptoms using the diagnostic criteria found in the DSM-IV
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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.
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Generalized Anxiety Disorder 7 (GAD-7)
Prazo: 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.
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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
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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.
|
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Kessler Psychological Distress Scale (K-10)
Prazo: 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.
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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.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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PTSD Checklist for DSM-V (PCL-5)
Prazo: 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.
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Twenty-item self-report measure of PTSD based on the DSM-V diagnostic criteria
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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.
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Rosenberg Self-Esteem Scale (RSES)
Prazo: 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.
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Ten-item self-report measure of global feelings of self-worth
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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.
|
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Multidimensional Scale of Perceived Social Support
Prazo: 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.
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Twelve-item self-report measure of perceived support from three sources: Family, friends, and a significant other
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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.
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Work and Social Adjustment Scale (WSAS)
Prazo: 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.
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Five-item self-report measure of impairment in functioning
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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.
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Physical Activity and Sleep
Prazo: Starting 1 month to 2 weeks prior to group auto-recorded ending 6 months after the conclusion of the running group.
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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
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Starting 1 month to 2 weeks prior to group auto-recorded ending 6 months after the conclusion of the running group.
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Delis-Kramer Executive Function Tower Task
Prazo: At baseline and 1-week after exercise program ends.
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Assesses spatial planning, rule learning, and response inhibition
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At baseline and 1-week after exercise program ends.
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Hopkins Verbal Learning Task
Prazo: At baseline and 1-week after exercise program ends.
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Tests participants' memory for a list of 12 nouns drawn from 3 categories, and measures immediate and delayed recall and recognition
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At baseline and 1-week after exercise program ends.
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N-back
Prazo: At baseline and 1-week after exercise program ends.
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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
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At baseline and 1-week after exercise program ends.
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Concentration Memory Task
Prazo: At baseline and 1-week after running program ends.
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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
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At baseline and 1-week after running program ends.
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Town Square
Prazo: At baseline and 1-week after running program ends.
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A test of viewpoint-dependent and -independent spatial memory for a set of visually presented items in a town square
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At baseline and 1-week after running program ends.
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Wechsler Test of Adult Reading
Prazo: At baseline
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A test to assess pre-morbid intellectual functioning by having the participants verbally speak a list of 50 irregular words
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At baseline
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Juliana Tobon, PhD, CPsych, St. Joseph's Research Institute - Youth Wellness Centre
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
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- 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.
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- 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.
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- 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.
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- RiskAnalytica. The life and economic impact of major mental illnesses in canada. Mental Health Commission of Canada. 2011:2011-2041.
- 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.
- 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.
- 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.
- 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.
- 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.
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- 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.
- 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.
- 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
- 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.
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- 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.
- 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.
- 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.
- 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.
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- Michael E. Sobel. Asymptotic confidence intervals for indirect effects in structural equation models. Sociological Methodology. 1982;13:290-312.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
31 de janeiro de 2017
Conclusão Primária (Real)
30 de novembro de 2018
Conclusão do estudo (Real)
30 de novembro de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
28 de abril de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de maio de 2017
Primeira postagem (Real)
8 de maio de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
21 de abril de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de abril de 2020
Última verificação
1 de abril de 2020
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 2785
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Não
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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