NCT04703296

Brief Summary

The overarching goal of this study is to develop, deliver, and investigate the utility and feasibility of train-the-trainer delivery of mindfulness training (MT) in support of improved readiness (across cognitive, affective, and social domains of the human dimension) and improve retention of candidates in the SOF qualification pipeline at the U.S. Army John F. Kennedy Special Warfare Center and School (referred to as SWCS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
245

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

March 16, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2023

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

9 months

First QC Date

January 7, 2021

Last Update Submit

January 11, 2023

Conditions

Keywords

Stress

Outcome Measures

Primary Outcomes (3)

  • Change in Attentional Performance

    Attentional Performance as measured by the Sustained Attention Response Task (SART). SART has a range of scores from 0 to 1 with a higher score indicating better accuracy of completing the task.

    Baseline (week 1) to week 6 (after 4-week training interval)

  • Change in Working Memory Performance

    Working Memory Performance as measured by the Working Memory Task with Affective Distracters (WMDA). WMDA has a range of scores from 0 to 100%, with higher scores indicating better accuracy on the task.

    Baseline (week 1) to week 6 (after 4-week training interval)

  • Change in Cognitive Failures

    Cognitive Failures will be measured by the Cognitive Failures Questionnaire (CFQ). CFQ has total score ranging from 0 to 100, with a higher score indicating more cognitive failures.

    Baseline (week 1) to week 6 (after 4-week training interval)

Secondary Outcomes (6)

  • Change in Positive Affect

    Baseline (week 1) to week 6 (after 4-week training interval)

  • Change in Negative Affect

    Baseline (week 1) to week 6 (after 4-week training interval)

  • Change in Perceived Stress

    Baseline (week 1) to week 6 (after 4-week training interval)

  • Change in Psychological Health

    Baseline (week 1) to week 6 (after 4-week training interval)

  • Change in Decentering

    Baseline (week 1) to week 6 (after 4-week training interval)

  • +1 more secondary outcomes

Other Outcomes (3)

  • Change in Post-Traumatic Stress Disorder (PTSD) symptomatology

    Baseline to week 6 and week 11.

  • Change in Perspective Taking

    Baseline (week 1) to week 6 (after 4-week training interval)

  • Applied Mindfulness Process Scale

    post training at at week 6

Study Arms (2)

Mindfulness training (MT) group

EXPERIMENTAL

Receives 4 weeks of mindfulness training followed by a testing session.

Behavioral: MBAT course

No-training control (NTC) group

NO INTERVENTION

Receives 4 weeks of no mindfulness training followed by a testing session.

Interventions

MBAT courseBEHAVIORAL

The MBAT will involve: (i) 4 weekly 1.5-hour course sessions. The sessions will provide guided exercises, didactic information, and discussions to promote greater mindfulness. (ii) Daily mindfulness practice that will be facilitated by the Measuring Mindfulness App (MMA) and/or instructor-delivered mindfulness practices. The daily mindfulness practice will require about 15 minutes to complete.

Mindfulness training (MT) 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.
  • Men and women of all races and ethnicities.
  • Individuals who are willing and able to consent to participate in the study.
  • Individuals who are attending Special Warfare Center and School (SWCS).

You may not qualify if:

  • Individuals who have a medical or neurological condition that might interfere with performance on the task in the study (e.g., epilepsy)
  • Individuals with a history of hospitalization for psychological/mental health issues within the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

Study Officials

  • Amishi Jha

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 11, 2021

Study Start

March 16, 2022

Primary Completion

December 7, 2022

Study Completion

January 9, 2023

Last Updated

January 12, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations