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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1896

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • South Carolina
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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.
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
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
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.
6-12 month follow-up
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.
6-12 month follow-up
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.
3-4 weeks; 9-10 weeks
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Walter Reed Army Institute of Research (WRAIR)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
U.S. Army Medical Research and Development Command
U.S. Army Training and Doctrine Command (TRADOC)

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 12, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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