Evaluation of Mindfulness and Yoga in Basic Combat Training

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Mindfulness and Yoga in Basic Combat Training

Conditions
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Depressive Symptoms, Anxiety, Sleep, Emotion Regulation, Pain, Military Operations, Cohesion, Social, Mindfulness, Yoga, Leadership, Health, Subjective, Stress, Mood, Musculoskeletal Injury

Intervention / Treatment
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* Behavioral: Mindfulness Based Attention Training (MBAT) and Yoga


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: U.S. Army soldiers participating in basic combat training from OCT - DEC 2020 at a U.S. Army installation in the southeastern United States. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: group randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness and Yoga<br>Mindfulness-Based Attention Training (MBAT) was delivered in 4, 2-hour sessions over 4 weeks. Yoga was delivered 6 days/week, 30 minutes per day. | Behavioral: Mindfulness Based Attention Training (MBAT) and Yoga<br>* Mindfulness-Based Attention Training (MBAT) was delivered in 4, 2-hour sessions over 4 weeks. Participants also completed 15 minutes of group mindfulness practice 6 days/week and received information on embedded practice during the duty day. Yoga was delivered 6 days/week, 30 minutes per day during warm-up (15 min) and cool-down (15 min) as part of Army physical readiness training.<br>|
| No Intervention: Training as Usual<br>Training as usual included standard exercises 30 minutes per day during warm-up (15 min) and cool-down (15 min) as part of Army physical readiness training. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire (PHQ) Two-Item Version: Change in Scores Over Time | 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. | 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up | 
| ICD-10 Musculoskeletal Diagnoses: Occurrence Over Time | ICD-10 musculoskeletal diagnoses (M group) and associated encounter information drawn from U.S. Army records | 0-10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generalized Anxiety Disorder (GAD) Two Item Version: Change Over Time | The GAD-2 is a validated screening tool for anxiety. The GAD-2 included a single item assessing impairment in functioning attributable to reported symptoms. | 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up | 
| Insomnia Severity Index (ISI): Change Over Time | The ISI is a validated screening tool for insomnia and sleep-related problems. | 0, 3-4, 6-7, and 9-10 weeks | 
| Pittsburgh Sleep Quality Index (PSQI) Sleep Quality Item: Change Over Time | A single item from the PSQI was used to assess overall sleep quality. | 0, 3-4, 6-7, and 9-10 weeks | 
| Defense and Veterans Pain Rating Scale (DVPRS): Change Over Time | The DVPRS is a measure of self-reported pain designed for use in military and veteran populations. The DVPRS was adapted for the present study to assess pain-related interference with training, sleep, mood, and stress. | 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up | 
| Patient Health Questionnaire (PHQ-15): Change Over Time | The PHQ-15 is a validated measure of a range of patient health outcomes. Ten items from the PHQ-15 were used to assess physical pain and assorted medical symptoms. | 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up | 
| Mental Toughness Inventory (MTI): Change Over Time | The MTI is a measure of mental toughness and resilience. Eight items from the MTI were used in the present evaluation: Four items assessed mental toughness during stressful events, and four items assessed mental toughness following stressful events. | 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up | 
| Multidimensional Assessment of Interoceptive Awareness (MAIA): Change Over Time | The MAIA is a measure of interoceptive awareness and mindfulness-related constructs. Ten items from the MAIA were used in the present evaluation: Six items assessed the capacity to not self-distract, and four items assessed capacity for self-regulation. | 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up | 
| Five Facet Mindfulness Questionnaire (FFMQ): Change Over Time | The FFMQ is a measure of engagement in mindful awareness. | 0, 3-4, 6-7, and 9-10 weeks | 
| Brief Difficulties in Emotion Regulation Scale (DERS): Change Over Time | The Brief DERS is a shortened version of a validated measure assessing ability to manage difficult emotions. Subscales assessed difficulties with emotional awareness, impulse control, and engaging in goal-directed behavior. | 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up | 
| Attitudes toward Mindfulness Training: Change Over Time | Four items developed for the current evaluation were used to assess perceived acceptability and utility of mindfulness training. | 0, 3-4, 6-7, and 9-10 weeks | 
| Overall Health: Change Over Time | A single item was used to assess self-rated health. | 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up | 
| Indiscipline: Occurrence Over Time | Seven items developed for the current evaluation were used to assess behaviors that reflect indiscipline and consequences experienced as a result of indiscipline. | 3-4, 6-7, and 9-10 weeks | 
| Satisfaction with Yoga or Preparatory and Recovery Drills: Change Over Time | Eleven items developed for this evaluation were used to assess satisfaction with yoga intervention and preparatory and recovery drills. | 3-4, 6-7, and 9-10 weeks | 
| Unit Cohesion: Change Over Time | A validated three-item measure was used to assess unit cohesion. | 3-4, 6-7, and 9-10 weeks | 
| Self-Reported Medical Visits: Occurrence Over Time | A single item measure developed for this evaluation was used to assess frequency of medical visits. | 0, 3-4, 6-7, and 9-10 weeks | 
| Self-Reported Pain: Change Over Time | Three items were developed for this evaluation assessing the frequency of pain, level of pain, and chronicity of pain. | 0, 3-4, 6-7, and 9-10 weeks | 
| Impact of Injury on Training: Change Over Time | Eight items developed for the present evaluation were used to assess disruption in training due to injury, trainee response to injury, and outcomes associated with experience of injury. | 3-4, 6-7, and 9-10 weeks | 
| Use of Mindfulness following Training | Twenty-five items were developed for the present evaluation to assess use of mindfulness and attitudes towards mindfulness practice following basic combat training. | 6-12 month follow-up | 
| Use of Yoga or Preparatory and Recovery Drills (PRT) following Training | Twenty-three items were developed for the present evaluation to assess use of yoga/PRT drills and attitudes towards yoga/PRT drills following basic combat training. | 6-12 month follow-up | 
| Use of Mindfulness and Yoga Resources following Training | Nine items were developed for this evaluation to assess receipt and use of mindfulness and yoga resources following training. | 6-12 month follow-up | 
| Use of Mindfulness during Training: Change Over Time | Thirteen items were developed for this evaluation to assess use of MBAT during basic combat training. | 3-4 weeks; 9-10 weeks | 
| Perceived Drill Sergeant Support for Mindfulness during Training: Change Over Time | Six items were developed for this evaluation to assess trainees' perception of drill sergeant support for MBAT during basic combat training. | 3-4 weeks; 9-10 weeks | 
| Drill Sergeant Leadership: Change Over Time | Nine items were used to assess participants' perceptions of the quality of drill sergeant's leadership and instruction. | 3-4 weeks; 9-10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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military, basic combat training, drill sergeant, Mindfulness-Based Attention Training, soldier