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临床试验/NCT05550610
NCT05550610已完成不适用

Evaluation of Mindfulness and Yoga in Basic Combat Training

Walter Reed Army Institute of Research (WRAIR)2 个研究点 分布在 1 个国家目标入组 1,896 人开始时间: 2020年10月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,896
试验地点
2
主要终点
Patient Health Questionnaire (PHQ) Two-Item Version: Change in Scores Over Time

研究概览

简要总结

The present study is a group randomized trial assessing the impact of mindfulness and yoga training on the health, performance, and well-being of soldiers in Basic Combat Training (BCT). Randomization occurred at the platoon level, and platoons received either a combined mindfulness and yoga regimen or training as usual.

详细描述

This program evaluation assessed a training initiative developed and implemented by the U.S. Army Training and Doctrine Command. Four surveys were conducted with soldiers in all participating platoons over the course of BCT, and two additional surveys were administered with those soldiers in the mindfulness and yoga intervention condition. A follow-up survey was distributed to all participants 6-12 months after BCT. In addition, two surveys were conducted with BCT cadre and drill sergeants. Army data reflecting performance, attrition, and health were also obtained for analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

All participants were aware whether they were assigned to receive mindfulness and yoga or training as usual.

入排标准

年龄范围
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • U.S. Army soldiers participating in basic combat training from OCT - DEC 2020 at a U.S. Army installation in the southeastern United States.

排除标准

  • 未提供

结局指标

主要结局

Patient Health Questionnaire (PHQ) Two-Item Version: Change in Scores Over Time

时间窗: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up

The PHQ-2 is a validated screening tool for depression. The PHQ-2 included a single item assessing impairment in functioning attributable to reported symptoms.

ICD-10 Musculoskeletal Diagnoses: Occurrence Over Time

时间窗: 0-10 weeks

ICD-10 musculoskeletal diagnoses (M group) and associated encounter information drawn from U.S. Army records

次要结局

  • Insomnia Severity Index (ISI): Change Over Time(0, 3-4, 6-7, and 9-10 weeks)
  • Pittsburgh Sleep Quality Index (PSQI) Sleep Quality Item: Change Over Time(0, 3-4, 6-7, and 9-10 weeks)
  • Patient Health Questionnaire (PHQ-15): Change Over Time(0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up)
  • Multidimensional Assessment of Interoceptive Awareness (MAIA): Change Over Time(0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up)
  • Satisfaction with Yoga or Preparatory and Recovery Drills: Change Over Time(3-4, 6-7, and 9-10 weeks)
  • Self-Reported Pain: Change Over Time(0, 3-4, 6-7, and 9-10 weeks)
  • Use of Mindfulness following Training(6-12 month follow-up)
  • Perceived Drill Sergeant Support for Mindfulness during Training: Change Over Time(3-4 weeks; 9-10 weeks)
  • Generalized Anxiety Disorder (GAD) Two Item Version: Change Over Time(0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up)
  • Unit Cohesion: Change Over Time(3-4, 6-7, and 9-10 weeks)
  • Self-Reported Medical Visits: Occurrence Over Time(0, 3-4, 6-7, and 9-10 weeks)
  • Use of Mindfulness and Yoga Resources following Training(6-12 month follow-up)
  • Mental Toughness Inventory (MTI): Change Over Time(0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up)
  • Five Facet Mindfulness Questionnaire (FFMQ): Change Over Time(0, 3-4, 6-7, and 9-10 weeks)
  • Indiscipline: Occurrence Over Time(3-4, 6-7, and 9-10 weeks)
  • Use of Mindfulness during Training: Change Over Time(3-4 weeks; 9-10 weeks)
  • Attitudes toward Mindfulness Training: Change Over Time(0, 3-4, 6-7, and 9-10 weeks)
  • Overall Health: Change Over Time(0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up)
  • Impact of Injury on Training: Change Over Time(3-4, 6-7, and 9-10 weeks)
  • Use of Yoga or Preparatory and Recovery Drills (PRT) following Training(6-12 month follow-up)
  • Drill Sergeant Leadership: Change Over Time(3-4 weeks; 9-10 weeks)
  • Defense and Veterans Pain Rating Scale (DVPRS): Change Over Time(0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up)
  • Brief Difficulties in Emotion Regulation Scale (DERS): Change Over Time(0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up)

研究者

发起方
Walter Reed Army Institute of Research (WRAIR)
申办方类型
Fed
责任方
Sponsor

研究点 (2)

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