- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03143582
Examining the Effects of a Team-based Running Program
2020년 4월 18일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ontario
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Hamilton, Ontario, 캐나다, L8P 4W6
- Youth Wellness Centre
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
17년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Healthy enough to participate in physical activity
Exclusion Criteria:
- NOT excluded on basis of mental health or addiction concerns
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient Health Questionnaire 9 (PHQ-9)
기간: 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)
기간: 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)
기간: 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
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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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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PTSD Checklist for DSM-V (PCL-5)
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Juliana Tobon, PhD, CPsych, St. Joseph's Research Institute - Youth Wellness Centre
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 1월 31일
기본 완료 (실제)
2018년 11월 30일
연구 완료 (실제)
2018년 11월 30일
연구 등록 날짜
최초 제출
2017년 4월 28일
QC 기준을 충족하는 최초 제출
2017년 5월 3일
처음 게시됨 (실제)
2017년 5월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 4월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 4월 18일
마지막으로 확인됨
2020년 4월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2785
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
스트레스에 대한 임상 시험
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