- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05550610
Evaluation of Mindfulness and Yoga in Basic Combat Training
September 19, 2022 updated by: Walter Reed Army Institute of Research (WRAIR)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
1896
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Carolina
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Fort Jackson, South Carolina, United States, 29702
- Fort Jackson
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Mindfulness and Yoga
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.
|
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.
|
NO_INTERVENTION: Training as Usual
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?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
|
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
|
0-10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
|
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.
|
0, 3-4, 6-7, and 9-10 weeks
|
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.
|
0, 3-4, 6-7, and 9-10 weeks
|
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.
|
0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
|
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.
|
0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
|
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.
|
0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
|
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.
|
0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
|
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.
|
0, 3-4, 6-7, and 9-10 weeks
|
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.
|
0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
|
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.
|
0, 3-4, 6-7, and 9-10 weeks
|
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.
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0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
|
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.
|
3-4, 6-7, and 9-10 weeks
|
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.
|
3-4, 6-7, and 9-10 weeks
|
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.
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3-4, 6-7, and 9-10 weeks
|
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.
|
0, 3-4, 6-7, and 9-10 weeks
|
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.
|
0, 3-4, 6-7, and 9-10 weeks
|
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.
|
3-4, 6-7, and 9-10 weeks
|
Use of Mindfulness following Training
Time Frame: 6-12 month follow-up
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Twenty-five items were developed for the present evaluation to assess use of mindfulness and attitudes towards mindfulness practice following basic combat training.
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6-12 month follow-up
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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.
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6-12 month follow-up
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Use of Mindfulness and Yoga Resources following Training
Time Frame: 6-12 month follow-up
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Nine items were developed for this evaluation to assess receipt and use of mindfulness and yoga resources following training.
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6-12 month follow-up
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Use of Mindfulness during Training: Change Over Time
Time Frame: 3-4 weeks; 9-10 weeks
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Thirteen items were developed for this evaluation to assess use of MBAT during basic combat training.
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3-4 weeks; 9-10 weeks
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Perceived Drill Sergeant Support for Mindfulness during Training: Change Over Time
Time Frame: 3-4 weeks; 9-10 weeks
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Six items were developed for this evaluation to assess trainees' perception of drill sergeant support for MBAT during basic combat training.
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3-4 weeks; 9-10 weeks
|
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.
|
3-4 weeks; 9-10 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 12, 2020
Primary Completion (ACTUAL)
December 16, 2020
Study Completion (ACTUAL)
December 31, 2021
Study Registration Dates
First Submitted
August 2, 2022
First Submitted That Met QC Criteria
September 19, 2022
First Posted (ACTUAL)
September 22, 2022
Study Record Updates
Last Update Posted (ACTUAL)
September 22, 2022
Last Update Submitted That Met QC Criteria
September 19, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WRAIR #2815
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data are available for research upon reasonable request and completion of institute-related agreements.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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