Evaluation of Mindfulness and Yoga in Basic Combat Training
Primary Purpose
Depressive Symptoms, Anxiety, Sleep
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Attention Training (MBAT) and Yoga
Sponsored by

About this trial
This is an interventional prevention trial for Depressive Symptoms focused on measuring military, basic combat training, soldier, drill sergeant, Mindfulness-Based Attention Training
Eligibility Criteria
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
Sites / Locations
- Fort Jackson
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mindfulness and Yoga
Training as Usual
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
ICD-10 Musculoskeletal Diagnoses: Occurrence Over Time
ICD-10 musculoskeletal diagnoses (M group) and associated encounter information drawn from U.S. Army records
Secondary Outcome Measures
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.
Insomnia Severity Index (ISI): Change Over Time
The ISI is a validated screening tool for insomnia and sleep-related problems.
Pittsburgh Sleep Quality Index (PSQI) Sleep Quality Item: Change Over Time
A single item from the PSQI was used to assess overall sleep quality.
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.
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.
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.
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.
Five Facet Mindfulness Questionnaire (FFMQ): Change Over Time
The FFMQ is a measure of engagement in mindful awareness.
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.
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.
Overall Health: Change Over Time
A single item was used to assess self-rated health.
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.
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.
Unit Cohesion: Change Over Time
A validated three-item measure was used to assess unit cohesion.
Self-Reported Medical Visits: Occurrence Over Time
A single item measure developed for this evaluation was used to assess frequency of medical visits.
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.
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.
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.
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.
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.
Use of Mindfulness during Training: Change Over Time
Thirteen items were developed for this evaluation to assess use of MBAT during basic combat training.
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.
Drill Sergeant Leadership: Change Over Time
Nine items were used to assess participants' perceptions of the quality of drill sergeant's leadership and instruction.
Full Information
NCT ID
NCT05550610
First Posted
August 2, 2022
Last Updated
September 19, 2022
Sponsor
Walter Reed Army Institute of Research (WRAIR)
Collaborators
U.S. Army Medical Research and Development Command, U.S. Army Training and Doctrine Command (TRADOC)
1. Study Identification
Unique Protocol Identification Number
NCT05550610
Brief Title
Evaluation of Mindfulness and Yoga in Basic Combat Training
Official Title
Evaluation of Mindfulness and Yoga in Basic Combat Training
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 12, 2020 (Actual)
Primary Completion Date
December 16, 2020 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Walter Reed Army Institute of Research (WRAIR)
Collaborators
U.S. Army Medical Research and Development Command, U.S. Army Training and Doctrine Command (TRADOC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Anxiety, Sleep, Emotion Regulation, Pain, Military Operations, Cohesion, Social, Mindfulness, Yoga, Leadership, Health, Subjective, Stress, Mood, Musculoskeletal Injury
Keywords
military, basic combat training, soldier, drill sergeant, Mindfulness-Based Attention Training
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
group randomized trial
Masking
None (Open Label)
Masking Description
All participants were aware whether they were assigned to receive mindfulness and yoga or training as usual.
Allocation
Randomized
Enrollment
1896 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness and Yoga
Arm Type
Experimental
Arm Description
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.
Arm Title
Training as Usual
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Attention Training (MBAT) and Yoga
Intervention Description
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 Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ) Two-Item Version: Change in Scores Over Time
Description
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.
Time Frame
0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
Title
ICD-10 Musculoskeletal Diagnoses: Occurrence Over Time
Description
ICD-10 musculoskeletal diagnoses (M group) and associated encounter information drawn from U.S. Army records
Time Frame
0-10 weeks
Secondary Outcome Measure Information:
Title
Generalized Anxiety Disorder (GAD) Two Item Version: Change Over Time
Description
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.
Time Frame
0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
Title
Insomnia Severity Index (ISI): Change Over Time
Description
The ISI is a validated screening tool for insomnia and sleep-related problems.
Time Frame
0, 3-4, 6-7, and 9-10 weeks
Title
Pittsburgh Sleep Quality Index (PSQI) Sleep Quality Item: Change Over Time
Description
A single item from the PSQI was used to assess overall sleep quality.
Time Frame
0, 3-4, 6-7, and 9-10 weeks
Title
Defense and Veterans Pain Rating Scale (DVPRS): Change Over Time
Description
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.
Time Frame
0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
Title
Patient Health Questionnaire (PHQ-15): Change Over Time
Description
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.
Time Frame
0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
Title
Mental Toughness Inventory (MTI): Change Over Time
Description
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.
Time Frame
0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
Title
Multidimensional Assessment of Interoceptive Awareness (MAIA): Change Over Time
Description
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.
Time Frame
0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
Title
Five Facet Mindfulness Questionnaire (FFMQ): Change Over Time
Description
The FFMQ is a measure of engagement in mindful awareness.
Time Frame
0, 3-4, 6-7, and 9-10 weeks
Title
Brief Difficulties in Emotion Regulation Scale (DERS): Change Over Time
Description
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.
Time Frame
0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
Title
Attitudes toward Mindfulness Training: Change Over Time
Description
Four items developed for the current evaluation were used to assess perceived acceptability and utility of mindfulness training.
Time Frame
0, 3-4, 6-7, and 9-10 weeks
Title
Overall Health: Change Over Time
Description
A single item was used to assess self-rated health.
Time Frame
0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
Title
Indiscipline: Occurrence Over Time
Description
Seven items developed for the current evaluation were used to assess behaviors that reflect indiscipline and consequences experienced as a result of indiscipline.
Time Frame
3-4, 6-7, and 9-10 weeks
Title
Satisfaction with Yoga or Preparatory and Recovery Drills: Change Over Time
Description
Eleven items developed for this evaluation were used to assess satisfaction with yoga intervention and preparatory and recovery drills.
Time Frame
3-4, 6-7, and 9-10 weeks
Title
Unit Cohesion: Change Over Time
Description
A validated three-item measure was used to assess unit cohesion.
Time Frame
3-4, 6-7, and 9-10 weeks
Title
Self-Reported Medical Visits: Occurrence Over Time
Description
A single item measure developed for this evaluation was used to assess frequency of medical visits.
Time Frame
0, 3-4, 6-7, and 9-10 weeks
Title
Self-Reported Pain: Change Over Time
Description
Three items were developed for this evaluation assessing the frequency of pain, level of pain, and chronicity of pain.
Time Frame
0, 3-4, 6-7, and 9-10 weeks
Title
Impact of Injury on Training: Change Over Time
Description
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.
Time Frame
3-4, 6-7, and 9-10 weeks
Title
Use of Mindfulness following Training
Description
Twenty-five items were developed for the present evaluation to assess use of mindfulness and attitudes towards mindfulness practice following basic combat training.
Time Frame
6-12 month follow-up
Title
Use of Yoga or Preparatory and Recovery Drills (PRT) following Training
Description
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.
Time Frame
6-12 month follow-up
Title
Use of Mindfulness and Yoga Resources following Training
Description
Nine items were developed for this evaluation to assess receipt and use of mindfulness and yoga resources following training.
Time Frame
6-12 month follow-up
Title
Use of Mindfulness during Training: Change Over Time
Description
Thirteen items were developed for this evaluation to assess use of MBAT during basic combat training.
Time Frame
3-4 weeks; 9-10 weeks
Title
Perceived Drill Sergeant Support for Mindfulness during Training: Change Over Time
Description
Six items were developed for this evaluation to assess trainees' perception of drill sergeant support for MBAT during basic combat training.
Time Frame
3-4 weeks; 9-10 weeks
Title
Drill Sergeant Leadership: Change Over Time
Description
Nine items were used to assess participants' perceptions of the quality of drill sergeant's leadership and instruction.
Time Frame
3-4 weeks; 9-10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Fort Jackson
City
Fort Jackson
State/Province
South Carolina
ZIP/Postal Code
29702
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data are available for research upon reasonable request and completion of institute-related agreements.
Citations:
PubMed Identifier
30394773
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.
Results Reference
background
PubMed Identifier
29364935
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.
Results Reference
background
PubMed Identifier
29705463
Citation
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.
Results Reference
background
PubMed Identifier
20141302
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.
Results Reference
background
PubMed Identifier
30999122
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.
Results Reference
background
PubMed Identifier
30732844
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.
Results Reference
background
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Evaluation of Mindfulness and Yoga in Basic Combat Training
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