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Completed

NCT Number: NCT04703296

Mindfulness Training in Special Operations Forces (SOF) Candidates

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).

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Key information

Conditions

Cognitive Change

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Coral Gables, Florida, 33146, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

MBAT course

Behavioral

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.

Primary outcomes

  1. Change in Attentional Performance

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

    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.

  2. Change in Working Memory Performance

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

    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.

  3. Change in Cognitive Failures

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

    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.

Secondary outcomes

  1. Change in Positive Affect

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

    Positive Affect will be measured by the Positive and Negative Affect Schedule (PANAS-10). The PANAS Positive has a range of scores from 5 to 25, with higher score indicating higher positive mood.

  2. Change in Negative Affect

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

    Negative Affect will be measured by the Positive and Negative Affect Schedule (PANAS-10). The PANAS Negative has a range of scores from 5 to 25, with higher score indicating higher negative mood.

  3. Change in Perceived Stress

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

    The short version of the Perceived Stress Scale (PSS) will be used assess perceived stress. The 4-item PSS has a range of scores from 0 to 16, with higher score indicating higher level of perceived stress.

  4. Change in Psychological Health

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

    Patient Health Questionnaire (PHQ-4) will be used to assess depression and anxiety. PHQ-4 has a range of scores from 0 to 12, with higher scores indicating higher level of depression and anxiety.

  5. Change in Decentering

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

    EQ Decentering is an 11-item sub-scale 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 high level of decentering.

  6. Change in Mind Wandering

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

    Four Factor Mind Wandering (4FMW) Questionnaire is a 16-item scale that asks participants to indicate how often they experience a situation described in the form of a statement on a 5-point Likert-type scale from never (1) to always (5). 4FMW has a range of scores from 16 to 80, with higher scores indicating greater mind wandering.

Other outcomes

  1. Change in Post-Traumatic Stress Disorder (PTSD) symptomatology

    Time frame: Baseline to week 6 and week 11.

    Post-traumatic Stress Disorder Checklist for military populations (PCL-M) will be used to measure symptoms of PTSD. PCL-M has a range of scores from 17 to 85, with higher scores indicating more PTSD symptoms.

  2. Change in Perspective Taking

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

    The Perspective Taking (PT) Subscale from the Interpersonal Reactivity Index (IRI) will be used to assess perspective-taking. The PT Subscale score ranges from 0 to 28, with a higher score indicating greater perspective-taking.

  3. Applied Mindfulness Process Scale

    Time frame: post training at at week 6

    Applied Mindfulness Process Scale measures how often people apply mindfulness practice in daily life.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • United States Department of Defense

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 11, 2021
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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