Evaluation of Mindfulness and Yoga in Basic Combat Training

Pain Clinical Trial

Official title:

Evaluation of Mindfulness and Yoga in Basic Combat Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05550610
• Other study ID #: WRAIR #2815
• Status: Completed
• Phase: N/A
• Start date: October 12, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2022
• Source: Walter Reed Army Institute of Research (WRAIR)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1896
• Est. completion date: December 31, 2021
• Est. primary completion date: December 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms
• Emotion Regulation
• Health, Subjective
• Leadership
• Military Operations
• Mindfulness
• Mood
• Musculoskeletal Injury
• Pain
• Sleep
• Stress
• Yoga

Intervention

Behavioral:
• Mindfulness Based Attention Training (MBAT) and Yoga
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.

Locations

Country	Name	City	State
United States	Fort Jackson	Fort Jackson	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Walter Reed Army Institute of Research (WRAIR)	U.S. Army Medical Research and Development Command, U.S. Army Training and Doctrine Command (TRADOC)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Domingues RB. Modern postural yoga as a mental health promoting tool: A systematic review. Complement Ther Clin Pract. 2018 May;31:248-255. doi: 10.1016/j.ctcp.2018.03.002. Epub 2018 Mar 10. Review. — View Citation

Janssen M, Heerkens Y, Kuijer W, van der Heijden B, Engels J. Effects of Mindfulness-Based Stress Reduction on employees' mental health: A systematic review. PLoS One. 2018 Jan 24;13(1):e0191332. doi: 10.1371/journal.pone.0191332. eCollection 2018. Review. — View Citation

Jha AP, Denkova E, Zanesco AP, Witkin JE, Rooks J, Rogers SL. Does mindfulness training help working memory 'work' better? Curr Opin Psychol. 2019 Aug;28:273-278. doi: 10.1016/j.copsyc.2019.02.012. Epub 2019 Mar 6. Review. — View Citation

Jha AP, Stanley EA, Kiyonaga A, Wong L, Gelfand L. Examining the protective effects of mindfulness training on working memory capacity and affective experience. Emotion. 2010 Feb;10(1):54-64. doi: 10.1037/a0018438. — View Citation

Nassif TH, Start AR, Toblin RL, Adler AB. Self-reported mindfulness and soldier health following a combat deployment. Psychol Trauma. 2019 May;11(4):466-474. doi: 10.1037/tra0000413. Epub 2018 Nov 5. — View Citation

Zanesco AP, Denkova E, Rogers SL, MacNulty WK, Jha AP. Mindfulness training as cognitive training in high-demand cohorts: An initial study in elite military servicemembers. Prog Brain Res. 2019;244:323-354. doi: 10.1016/bs.pbr.2018.10.001. Epub 2018 Nov 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Unit Cohesion: Change Over Time	A validated three-item measure was used to assess unit cohesion.	3-4, 6-7, and 9-10 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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