NCT04576832

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.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 6, 2020

Completed
2.1 years until next milestone

Study Start

First participant enrolled

November 10, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2023

Completed
Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

5 months

First QC Date

September 30, 2020

Last Update Submit

June 26, 2024

Conditions

Cognitive Change

Keywords

mindfulness trainingpsychological health

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in 5FMQ scores

    Baseline (T1) to post-4-week training interval (T2).

  • Change in Decentering score

    Baseline (T1) to post-4-week training interval (T2).

  • Change in PANAS positive affect score

    Baseline (T1) to post-4-week training interval (T2).

  • Change in PANAS negative affect score

    Baseline (T1) to post-4-week training interval (T2).

  • Change in PSS score

    Baseline (T1) to post-4-week training interval (T2).

  • +1 more secondary outcomes

Other Outcomes (4)

  • Change in Leadership Questionnaire

    Baseline (T1) to post-4-week training interval (T2).

  • Change in Anger score

    Baseline (T1) to post-4-week training interval (T2).

  • Change in Marital Satisfaction

    Baseline (T1) to post-4-week training interval (T2).

  • +1 more other outcomes

Study Arms (2)

Group A (MT group)

EXPERIMENTAL

Participants will receive 4 weeks of mindfulness training during the first training interval between the first (T1) and second (T2) assessment sessions.

Behavioral: Mindfulness-Based Attention Training (MBAT) web-course

Group B (Wait-list group)

ACTIVE COMPARATOR

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.

Behavioral: Mindfulness-Based Attention Training (MBAT) web-course

Interventions

Mindfulness-Based Attention Training (MBAT) web-courseBEHAVIORAL

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.

Group A (MT group)Group B (Wait-list group)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • \. Individuals who have been hospitalized for psychological/mental health issues within the last month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Amishi Jha

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 30, 2020

First Posted

October 6, 2020

Study Start

November 10, 2022

Primary Completion

April 20, 2023

Study Completion

April 20, 2023

Last Updated

June 28, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)