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Completed

NCT Number: NCT05550610

Evaluation of Mindfulness and Yoga in Basic Combat Training

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Based Attention Training (MBAT) and Yoga

Behavioral

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.

Primary outcomes

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

    Time frame: 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.

  2. ICD-10 Musculoskeletal Diagnoses: Occurrence Over Time

    Time frame: 0-10 weeks

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

Secondary outcomes

  1. Generalized Anxiety Disorder (GAD) Two Item Version: Change Over Time

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

    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.

  2. Insomnia Severity Index (ISI): Change Over Time

    Time frame: 0, 3-4, 6-7, and 9-10 weeks

    The ISI is a validated screening tool for insomnia and sleep-related problems.

  3. Pittsburgh Sleep Quality Index (PSQI) Sleep Quality Item: Change Over Time

    Time frame: 0, 3-4, 6-7, and 9-10 weeks

    A single item from the PSQI was used to assess overall sleep quality.

  4. Defense and Veterans Pain Rating Scale (DVPRS): Change Over Time

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

    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.

  5. Patient Health Questionnaire (PHQ-15): Change Over Time

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

    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.

  6. Mental Toughness Inventory (MTI): Change Over Time

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

    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.

  7. Multidimensional Assessment of Interoceptive Awareness (MAIA): Change Over Time

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

    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.

  8. Five Facet Mindfulness Questionnaire (FFMQ): Change Over Time

    Time frame: 0, 3-4, 6-7, and 9-10 weeks

    The FFMQ is a measure of engagement in mindful awareness.

  9. Brief Difficulties in Emotion Regulation Scale (DERS): Change Over Time

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

    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.

  10. Attitudes toward Mindfulness Training: Change Over Time

    Time frame: 0, 3-4, 6-7, and 9-10 weeks

    Four items developed for the current evaluation were used to assess perceived acceptability and utility of mindfulness training.

  11. Overall Health: Change Over Time

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

    A single item was used to assess self-rated health.

  12. Indiscipline: Occurrence Over Time

    Time frame: 3-4, 6-7, and 9-10 weeks

    Seven items developed for the current evaluation were used to assess behaviors that reflect indiscipline and consequences experienced as a result of indiscipline.

  13. Satisfaction with Yoga or Preparatory and Recovery Drills: Change Over Time

    Time frame: 3-4, 6-7, and 9-10 weeks

    Eleven items developed for this evaluation were used to assess satisfaction with yoga intervention and preparatory and recovery drills.

  14. Unit Cohesion: Change Over Time

    Time frame: 3-4, 6-7, and 9-10 weeks

    A validated three-item measure was used to assess unit cohesion.

  15. Self-Reported Medical Visits: Occurrence Over Time

    Time frame: 0, 3-4, 6-7, and 9-10 weeks

    A single item measure developed for this evaluation was used to assess frequency of medical visits.

  16. Self-Reported Pain: Change Over Time

    Time frame: 0, 3-4, 6-7, and 9-10 weeks

    Three items were developed for this evaluation assessing the frequency of pain, level of pain, and chronicity of pain.

  17. Impact of Injury on Training: Change Over Time

    Time frame: 3-4, 6-7, and 9-10 weeks

    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.

  18. Use of Mindfulness following Training

    Time frame: 6-12 month follow-up

    Twenty-five items were developed for the present evaluation to assess use of mindfulness and attitudes towards mindfulness practice following basic combat training.

  19. Use of Yoga or Preparatory and Recovery Drills (PRT) following Training

    Time frame: 6-12 month follow-up

    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.

  20. Use of Mindfulness and Yoga Resources following Training

    Time frame: 6-12 month follow-up

    Nine items were developed for this evaluation to assess receipt and use of mindfulness and yoga resources following training.

  21. Use of Mindfulness during Training: Change Over Time

    Time frame: 3-4 weeks; 9-10 weeks

    Thirteen items were developed for this evaluation to assess use of MBAT during basic combat training.

  22. Perceived Drill Sergeant Support for Mindfulness during Training: Change Over Time

    Time frame: 3-4 weeks; 9-10 weeks

    Six items were developed for this evaluation to assess trainees' perception of drill sergeant support for MBAT during basic combat training.

  23. Drill Sergeant Leadership: Change Over Time

    Time frame: 3-4 weeks; 9-10 weeks

    Nine items were used to assess participants' perceptions of the quality of drill sergeant's leadership and instruction.

Sponsors and collaborators

Lead sponsor

Walter Reed Army Institute of Research (WRAIR)

Fed

Collaborators

  • U.S. Army Medical Research and Development Command
  • U.S. Army Training and Doctrine Command (TRADOC)

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Sep 22, 2022
Registry last updated
Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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