Mindfulness Training for Senior Leaders

Sponsor
University of Miami (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04576832
Collaborator
United States Department of Defense (U.S. Fed)
300
1
2
40
7.5

Study Details

Study Description

Brief Summary

The overarching goal of the project is to investigate if a mindfulness-based attention training (MBAT) program contextualized for Military Senior Leaders (SLs) might benefit SLs in three key domains: (1) cognitive abilities, (2) psychological well-being and self-reported physical health, and (3) strategic leadership skills and ability. The MBAT-SL program will be tested by the training cohorts and compared to the wait-list control cohorts who will receive the training after a no-training interval.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness-Based Attention Training (MBAT) web-course
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Mindfulness Training for U.S. Army Senior Leaders
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2026
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A (MT group)

Participants will receive 4 weeks of mindfulness training.

Behavioral: Mindfulness-Based Attention Training (MBAT) web-course
Pre-recorded weekly sessions for 4 weeks. Each session will consist of approximately 2 hours of video content per week and weekly mindfulness exercises. This video will include MBAT program lectures, pre-recorded testimony from military leaders, and teaching materials. The course will also include 15-min daily mindfulness practice drills.

Active Comparator: Group B (Wait-list group)

Participants will begin with a 4-week no-training interval followed by 4 weeks of mindfulness training.

Behavioral: Mindfulness-Based Attention Training (MBAT) web-course
Pre-recorded weekly sessions for 4 weeks. Each session will consist of approximately 2 hours of video content per week and weekly mindfulness exercises. This video will include MBAT program lectures, pre-recorded testimony from military leaders, and teaching materials. The course will also include 15-min daily mindfulness practice drills.

Outcome Measures

Primary Outcome Measures

  1. Change in Sustained attention to response task (SART) score [Baseline (T1) to week 6 (T2) and week 11 (T3).]

    The SART involves pressing a button to frequently presented non-target trials (numbers 1, 2, 4, 5, 6, 7, 8, and 9) and withholding the button press to the infrequent target trials (number 3). The participants can have a total score between 0 and 100% with a higher score indicating better sustained attention.

Secondary Outcome Measures

  1. Change in the Working Memory Task with Affective Distraction (WMDA) score [Baseline (T1) to week 6 (T2) and week 11 (T3).]

    participants are presented with a memory item that they need to memorize and hold in memory during a delay interval. During the delay, emotionally negative or neutral scene images are presented. he participants can have a total score between 0 and 100% with a higher score indicating better working memory.

  2. Change in 5FMQ scores [Baseline (T1) to week 6 (T2) and week 11 (T3).]

    Five-Facet Mindfulness Questionnaire (5FMQ) is used to assess the five major aspects of mindfulness. The present study will use the 15-item short version. The scores range from 15 to 75, with higher scores indicating greater levels of mindfulness in different aspects of one's life.

  3. Change in PHQ4 scores [Baseline (T1) to week 6 (T2) and week 11 (T3).]

    Patient Health Questionnaire 4 items (PHQ4) is an ultra-brief 4-item measure of depression and anxiety in the general population with the total score ranging from 0 to 12. Higher score indicates higher level of anxiety and depression.

  4. Change in PANAS scores [Baseline (T1) to week 6 (T2) and week 11 (T3).]

    Positive and Negative Affect Scale (PANAS) is a widely used self-reported measure of positive and negative affect. The present study will use the 10-item short version with 5-item positive subscale and 5-item negative subscale. The score for each sub-scale ranges from 5 to 25 with higher score indicating higher positive or negative mood, respectively.

  5. Change in PSS scores [Baseline (T1) to week 6 (T2) and week 11 (T3).]

    Perceived Stress Scale (PSS) is a questionnaire measuring the degree to which situations in one's life are viewed as stressful within the past month. The present study will use the 4-item short version, with the total score ranging from 0 to 16. Higher score indicates higher level of perceived stress.

  6. Change in ISI scores [Baseline (T1) to week 6 (T2) and week 11 (T3).]

    Insomnia Severity Index (ISI) is a self-reported assessment of sleep pattern and quality. The index consists of 7-items and the scores range from 0 to 28, with higher scores indicating severe insomnia.

  7. Change in R-UCLA scores [Baseline (T1) to week 6 (T2) and week 11 (T3).]

    Revised-UCLA Loneliness Scale (R-UCLA) measures one's perceptions of isolation and satisfaction with one's social life. This is a shortened 9-item version of the R-UCLA with scores ranging from 9 to 36. Higher scores indicate greater perceived isolation.

  8. Change in Decentering score [Baseline (T1) to week 6 (T2) and week 11 (T3).]

    Decentering consists of 11 items measuring various thoughts and experiences, and the tendency to distance from those. The decentering score ranges from 1 to 55, with higher score indicating high level of decentering.

  9. Change in Anger score [Baseline (T1) to week 6 (T2) and week 11 (T3).]

    Dimensions of Anger Reactions (DAR-5) is a self-report measure of anger frequency, intensity, duration, aggression, and impact on social functioning over the past 4 weeks. The scale includes 4 items with a score range of 5-25. Higher scores indicate worse symptomatology, and a score equal to or greater than 12 indicates problematic anger levels.

Other Outcome Measures

  1. Change in Marital Satisfaction [Baseline (T1) to week 6 (T2) and week 11 (T3).]

    Marital Satisfaction Questionnaire (MSAT) measures one's satisfaction in their current relationship. The scale includes 4 items with a score range of 3-21. Higher scores indicate greater satisfaction with a current relationship.

  2. Change in Leadership Questionnaire [Baseline (T1) to week 6 (T2) and week 11 (T3).]

    Leadership Questionnaire consists of a set of questions that gather information about the self-reported leadership skills and attitudes of Senior Army leaders.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Individuals who are between 18 and 65 years of age.

  2. Individuals who are fluent English speakers.

  3. Individuals who are active-duty service members

  4. Individuals who are willing and able to consent to participate in the study.

  5. Individuals who participated in the courses provided by the Army War College (AWC).

Exclusion Criteria:
  1. Individuals who have been hospitalized for psychological/mental health issues within the last month

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Miami Coral Gables Florida United States 33146

Sponsors and Collaborators

  • University of Miami
  • United States Department of Defense

Investigators

  • Principal Investigator: Amishi Jha, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amishi Jha, Associate Professor, University of Miami
ClinicalTrials.gov Identifier:
NCT04576832
Other Study ID Numbers:
  • 20201075
  • W911QY-17-C-0101
First Posted:
Oct 6, 2020
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Amishi Jha, Associate Professor, University of Miami

Study Results

No Results Posted as of Aug 25, 2022