NCT05550610

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,896

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

2 months

First QC Date

August 2, 2022

Last Update Submit

September 19, 2022

Conditions

Depressive SymptomsAnxietySleepEmotion RegulationPainMilitary OperationsCohesion, SocialMindfulnessYogaLeadershipHealth, SubjectiveStressMoodMusculoskeletal Injury

Keywords

militarybasic combat trainingsoldierdrill sergeantMindfulness-Based Attention Training

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (23)

  • Generalized Anxiety Disorder (GAD) Two Item Version: Change Over Time

    0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up

  • Insomnia Severity Index (ISI): Change Over Time

    0, 3-4, 6-7, and 9-10 weeks

  • Pittsburgh Sleep Quality Index (PSQI) Sleep Quality Item: Change Over Time

    0, 3-4, 6-7, and 9-10 weeks

  • Defense and Veterans Pain Rating Scale (DVPRS): Change Over Time

    0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up

  • Patient Health Questionnaire (PHQ-15): Change Over Time

    0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up

  • +18 more secondary outcomes

Study Arms (2)

Mindfulness and Yoga

EXPERIMENTAL

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

Training as Usual

NO INTERVENTION

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.

Interventions

Mindfulness Based Attention Training (MBAT) and YogaBEHAVIORAL

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.

Mindfulness and Yoga

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • U.S. Army soldiers participating in basic combat training from OCT - DEC 2020 at a U.S. Army installation in the southeastern United States.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fort Jackson

Fort Jackson, South Carolina, 29702, United States

Location

Related Publications (8)

  • 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.

    PMID: 30394773BACKGROUND

  • 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.

    PMID: 29364935BACKGROUND

  • 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.

    PMID: 29705463BACKGROUND

  • 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.

    PMID: 20141302BACKGROUND

  • 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.

    PMID: 30999122BACKGROUND

  • 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.

    PMID: 30732844BACKGROUND

  • Nassif TH, Gutierrez IA, Smith CD, Jha AP, Adler AB. The Effect of a Combined Mindfulness and Yoga Intervention on Soldier Mental Health in Basic Combat Training: A Cluster Randomized Controlled Trial. Depress Anxiety. 2023 Dec 1;2023:6869543. doi: 10.1155/2023/6869543. eCollection 2023.

    PMID: 40224611DERIVED

  • Smith CD, Gutierrez IA, Nassif TH, Jordan KL, Taylor KM, Jha AP, Adler AB. Impact of mindfulness training and yoga on injury and pain-related impairment: a group randomized trial in basic combat training. Front Psychol. 2023 Oct 6;14:1214039. doi: 10.3389/fpsyg.2023.1214039. eCollection 2023.

    PMID: 37868598DERIVED

MeSH Terms

Conditions

DepressionAnxiety DisordersEmotional RegulationPain

Interventions

Yoga

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersSelf-ControlSocial BehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
All participants were aware whether they were assigned to receive mindfulness and yoga or training as usual.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: group randomized trial
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2022

First Posted

September 22, 2022

Study Start

October 12, 2020

Primary Completion

December 16, 2020

Study Completion

December 31, 2021

Last Updated

September 22, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Data are available for research upon reasonable request and completion of institute-related agreements.

Locations

US(1)