Mindfulness Training for Senior Leaders

Cognitive Change Clinical Trial

Official title:

Mindfulness Training for U.S. Army Senior Leaders

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04576832
• Other study ID #: 20201075
• Secondary ID: W911QY-17-C-0101
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 10, 2022
• Est. completion date: February 2026

Study information

• Verified date: March 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Change

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Coral Gables	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Leadership Questionnaire	Leadership Questionnaire consists of a set of questions that gather information about the self-reported leadership skills and attitudes of Senior Army leaders.	Baseline (T1) to post-4-week training interval (T2).
Other	Change in Anger score	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 greater anger levels.	Baseline (T1) to post-4-week training interval (T2).
Other	Change in Marital Satisfaction	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.	Baseline (T1) to post-4-week training interval (T2).
Other	Applied Mindfulness Practice	The Applied Mindfulness Process Scale (AMPS) measures one's daily enactment of mindfulness in daily life. Total score ranges from 0 to 60: a higher score indicates a greater application of mindfulness in everyday life.	Post-4-week training interval 1 (T2) and post-4-week training interval 2 (T3).
Primary	Change in Sustained attention to response task (SART) score	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.	Baseline (T1) to post-4-week training interval (T2).
Secondary	Change in 5FMQ scores	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.	Baseline (T1) to post-4-week training interval (T2).
Secondary	Change in Decentering score	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 a higher score indicating a high level of decentering.	Baseline (T1) to post-4-week training interval (T2).
Secondary	Change in PANAS positive affect score	Positive and Negative Affect Scale (PANAS) is a widely used self-reported measure of positive and negative affect. The present study will use a short version with a 5-item positive subscale. The score ranges from 5 to 25 with a higher score indicating a higher positive mood.	Baseline (T1) to post-4-week training interval (T2).
Secondary	Change in PANAS negative affect score	Positive and Negative Affect Scale (PANAS) is a widely used self-reported measure of positive and negative affect. The present study will use a short version with a 5-item negative subscale. The score ranges from 5 to 25 with a higher score indicating a higher negative mood.	Baseline (T1) to post-4-week training interval (T2).
Secondary	Change in PSS score	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, with a higher score indicating a higher level of perceived stress.	Baseline (T1) to post-4-week training interval (T2).
Secondary	Change in PHQ4 scores	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.	Baseline (T1) to post-4-week training interval (T2).