Pain Clinical Trial
Official title:
Evaluation of Mindfulness and Yoga in Basic Combat Training
Verified date | September 2022 |
Source | Walter Reed Army Institute of Research (WRAIR) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Fort Jackson | Fort Jackson | South Carolina |
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) |
United States,
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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
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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
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 |
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