Examining the Effects of a Team-based Running Program
2020年4月18日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
30
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Ontario
-
Hamilton、Ontario、カナダ、L8P 4W6
- Youth Wellness Centre
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
17年～25年 (子、大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Healthy enough to participate in physical activity
Exclusion Criteria:
- NOT excluded on basis of mental health or addiction concerns
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Running group
13 week, bi-weekly running group
|
A 13-week running program where youth run for 30 minutes twice weekly.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient Health Questionnaire 9 (PHQ-9)
時間枠：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)
時間枠：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)
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
PTSD Checklist for DSM-V (PCL-5)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：At baseline
|
A test to assess pre-morbid intellectual functioning by having the participants verbally speak a list of 50 irregular words
|
At baseline
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Juliana Tobon, PhD, CPsych、St. Joseph's Research Institute - Youth Wellness Centre
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年1月31日
一次修了 (実際)
2018年11月30日
研究の完了 (実際)
2018年11月30日
試験登録日
最初に提出
2017年4月28日
QC基準を満たした最初の提出物
2017年5月3日
最初の投稿 (実際)
2017年5月8日
学習記録の更新
投稿された最後の更新 (実際)
2020年4月21日
QC基準を満たした最後の更新が送信されました
2020年4月18日
最終確認日
2020年4月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2785
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。