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).

Study Overview

• Status: Completed
• Conditions: Cognitive Change
• Intervention / Treatment: Behavioral: MBAT course

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness training (MT) group; Receives 4 weeks of mindfulness training followed by a testing session.	Behavioral: MBAT course; 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.
No Intervention: No-training control (NTC) group; Receives 4 weeks of no mindfulness training followed by a testing session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Positive Affect	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.	Baseline (week 1) to week 6 (after 4-week training interval)
Change in Negative Affect	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.	Baseline (week 1) to week 6 (after 4-week training interval)
Change in Perceived Stress	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.	Baseline (week 1) to week 6 (after 4-week training interval)
Change in Psychological Health	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.	Baseline (week 1) to week 6 (after 4-week training interval)
Change in Decentering	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.	Baseline (week 1) to week 6 (after 4-week training interval)
Change in Mind Wandering	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.	Baseline (week 1) to week 6 (after 4-week training interval)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Post-Traumatic Stress Disorder (PTSD) symptomatology	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.	Baseline to week 6 and week 11.
Change in Perspective Taking	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.	Baseline (week 1) to week 6 (after 4-week training interval)
Applied Mindfulness Process Scale	Applied Mindfulness Process Scale measures how often people apply mindfulness practice in daily life.	post training at at week 6

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Amishi Jha, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2022
• Primary Completion (Actual): December 7, 2022
• Study Completion (Actual): January 9, 2023

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Stress
• Other Study ID Numbers: 20201488; W81XWH20C0065 (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