- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04576832
Mindfulness Training for Senior Leaders
June 26, 2024 updated by: Amishi Jha, University of Miami
Mindfulness Training for U.S. Army Senior Leaders
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
91
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
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Coral Gables, Florida, United States, 33146
- University of Miami
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Individuals who are between 18 and 65 years of age.
- Individuals who are fluent English speakers.
- Individuals who are active-duty service members
- Individuals who are willing and able to consent to participate in the study.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A (MT group)
Participants will receive 4 weeks of mindfulness training during the first training interval between the first (T1) and second (T2) assessment sessions.
|
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 not receive 4 weeks of mindfulness training during the first training interval; they will receive 4 weeks of mindfulness training during the second training interval between the second (T2) and third (T3) assessment sessions.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Sustained attention to response task (SART) score
Time Frame: Baseline (T1) to post-4-week training interval (T2).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in 5FMQ scores
Time Frame: Baseline (T1) to post-4-week training interval (T2).
|
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).
|
|
Change in Decentering score
Time Frame: Baseline (T1) to post-4-week training interval (T2).
|
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).
|
|
Change in PANAS positive affect score
Time Frame: Baseline (T1) to post-4-week training interval (T2).
|
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).
|
|
Change in PANAS negative affect score
Time Frame: Baseline (T1) to post-4-week training interval (T2).
|
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).
|
|
Change in PSS score
Time Frame: Baseline (T1) to post-4-week training interval (T2).
|
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).
|
|
Change in PHQ4 scores
Time Frame: Baseline (T1) to post-4-week training interval (T2).
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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).
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Applied Mindfulness Practice
Time Frame: Post-4-week training interval 1 (T2) and post-4-week training interval 2 (T3).
|
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).
|
|
Change in Leadership Questionnaire
Time Frame: Baseline (T1) to post-4-week training interval (T2).
|
Leadership Questionnaire consists of a set of questions that gather information about the self-reported leadership skills and attitudes of Senior Army leaders.
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Baseline (T1) to post-4-week training interval (T2).
|
|
Change in Anger score
Time Frame: Baseline (T1) to post-4-week training interval (T2).
|
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.
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Baseline (T1) to post-4-week training interval (T2).
|
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Change in Marital Satisfaction
Time Frame: Baseline (T1) to post-4-week training interval (T2).
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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.
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Baseline (T1) to post-4-week training interval (T2).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Amishi Jha, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 10, 2022
Primary Completion (Actual)
April 20, 2023
Study Completion (Actual)
April 20, 2023
Study Registration Dates
First Submitted
September 30, 2020
First Submitted That Met QC Criteria
September 30, 2020
First Posted (Actual)
October 6, 2020
Study Record Updates
Last Update Posted (Actual)
June 28, 2024
Last Update Submitted That Met QC Criteria
June 26, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20201075
- W911QY-17-C-0101 (Other Grant/Funding Number: Department of Defense)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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