Clinical trial NCT05550610: Evaluation of Mindfulness and Yoga in Basic Combat Training
Official title: Evaluation of Mindfulness and Yoga in Basic Combat Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Walter Reed Army Institute of Research (WRAIR)
Sponsor class: FED
Collaborators: name: U.S. Army Medical Research and Development Command
name: U.S. Army Training and Doctrine Command (TRADOC)
First posted: 2022-09-22
Enrollment: 1896
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group randomized trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Patient Health Questionnaire (PHQ) Two-Item Version: Change in Scores Over Time
timeFrame: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
measure: ICD-10 Musculoskeletal Diagnoses: Occurrence Over Time
timeFrame: 0-10 weeks
Secondary outcomes:
measure: Generalized Anxiety Disorder (GAD) Two Item Version: Change Over Time
timeFrame: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
measure: Insomnia Severity Index (ISI): Change Over Time
timeFrame: 0, 3-4, 6-7, and 9-10 weeks
measure: Pittsburgh Sleep Quality Index (PSQI) Sleep Quality Item: Change Over Time
timeFrame: 0, 3-4, 6-7, and 9-10 weeks
measure: Defense and Veterans Pain Rating Scale (DVPRS): Change Over Time
timeFrame: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
measure: Patient Health Questionnaire (PHQ-15): Change Over Time
timeFrame: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
measure: Mental Toughness Inventory (MTI): Change Over Time
timeFrame: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA): Change Over Time
timeFrame: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
measure: Five Facet Mindfulness Questionnaire (FFMQ): Change Over Time
timeFrame: 0, 3-4, 6-7, and 9-10 weeks
measure: Brief Difficulties in Emotion Regulation Scale (DERS): Change Over Time
timeFrame: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
measure: Attitudes toward Mindfulness Training: Change Over Time
timeFrame: 0, 3-4, 6-7, and 9-10 weeks
measure: Overall Health: Change Over Time
timeFrame: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
measure: Indiscipline: Occurrence Over Time
timeFrame: 3-4, 6-7, and 9-10 weeks
measure: Satisfaction with Yoga or Preparatory and Recovery Drills: Change Over Time
timeFrame: 3-4, 6-7, and 9-10 weeks
measure: Unit Cohesion: Change Over Time
timeFrame: 3-4, 6-7, and 9-10 weeks
measure: Self-Reported Medical Visits: Occurrence Over Time
timeFrame: 0, 3-4, 6-7, and 9-10 weeks
measure: Self-Reported Pain: Change Over Time
timeFrame: 0, 3-4, 6-7, and 9-10 weeks
measure: Impact of Injury on Training: Change Over Time
timeFrame: 3-4, 6-7, and 9-10 weeks
measure: Use of Mindfulness following Training
timeFrame: 6-12 month follow-up
measure: Use of Yoga or Preparatory and Recovery Drills (PRT) following Training
timeFrame: 6-12 month follow-up
measure: Use of Mindfulness and Yoga Resources following Training
timeFrame: 6-12 month follow-up
measure: Use of Mindfulness during Training: Change Over Time
timeFrame: 3-4 weeks; 9-10 weeks
measure: Perceived Drill Sergeant Support for Mindfulness during Training: Change Over Time
timeFrame: 3-4 weeks; 9-10 weeks
measure: Drill Sergeant Leadership: Change Over Time
timeFrame: 3-4 weeks; 9-10 weeks
Other outcomes:
Locations:
city: Fort Jackson
country: United States
facility: Fort Jackson
state: South Carolina
Study officials:
References:
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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.