- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03143582
Examining the Effects of a Team-based Running Program
18 kwietnia 2020 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
30
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
Ontario
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Hamilton, Ontario, Kanada, L8P 4W6
- Youth Wellness Centre
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
17 lat do 25 lat (Dziecko, Dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Healthy enough to participate in physical activity
Exclusion Criteria:
- NOT excluded on basis of mental health or addiction concerns
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Patient Health Questionnaire 9 (PHQ-9)
Ramy czasowe: 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
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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)
Ramy czasowe: 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
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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)
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
PTSD Checklist for DSM-V (PCL-5)
Ramy czasowe: 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)
Ramy czasowe: 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.
|
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Multidimensional Scale of Perceived Social Support
Ramy czasowe: 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.
|
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Work and Social Adjustment Scale (WSAS)
Ramy czasowe: 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
|
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
Ramy czasowe: 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
|
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
Ramy czasowe: 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
Ramy czasowe: 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.
|
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N-back
Ramy czasowe: 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.
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Concentration Memory Task
Ramy czasowe: 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
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At baseline and 1-week after running program ends.
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Town Square
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Juliana Tobon, PhD, CPsych, St. Joseph's Research Institute - Youth Wellness Centre
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
31 stycznia 2017
Zakończenie podstawowe (Rzeczywisty)
30 listopada 2018
Ukończenie studiów (Rzeczywisty)
30 listopada 2018
Daty rejestracji na studia
Pierwszy przesłany
28 kwietnia 2017
Pierwszy przesłany, który spełnia kryteria kontroli jakości
3 maja 2017
Pierwszy wysłany (Rzeczywisty)
8 maja 2017
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
21 kwietnia 2020
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
18 kwietnia 2020
Ostatnia weryfikacja
1 kwietnia 2020
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 2785
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Nie
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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