Mindfulness Training in Special Operations Forces (SOF) Candidates

• ClinicalTrials.gov Identifier: NCT04703296
• Recruitment Status: Not yet recruiting
• First Posted: January 11, 2021
• Last Update Posted: February 11, 2022
• Sponsor: University of Miami
• Collaborator: United States Department of Defense
• Information provided by (Responsible Party): Amishi Jha, University of Miami

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Cognitive Change	Behavioral: MBAT course	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Mindfulness Training in Special Operations Forces (SOF) Candidates
• Estimated Study Start Date: March 14, 2022
• Estimated Primary Completion Date: May 1, 2025
• Estimated Study Completion Date: May 1, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group A: Mindfulness training (MT) group; Receives 4 weeks of mindfulness training followed by a testing session. Then, 4 weeks of no-training interval 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.
Experimental: Group B: Wait-list control (WLC) group; Receives 4 weeks of no-training interval followed by a testing session. Then, 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.

Outcome Measures

Primary Outcome Measures :

1. Change in Attentional Performance [ Time Frame: Baseline to week 6 and week 11. ]
   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 to week 6 and week 11. ]
   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 to week 6 and week 11. ]
   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 Outcome Measures :

1. Change in Positive Affect [ Time Frame: Baseline to week 6 and week 11. ]
   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 to week 6 and week 11. ]
   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 to week 6 and week 11. ]
   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 to week 6 and week 11. ]
   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 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.
6. Change in Perspective Taking [ Time Frame: Baseline to week 6 and week 11. ]
   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.
7. Change in Decentering [ Time Frame: Baseline to week 6 and week 11. ]
   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.
8. Change in Mind Wandering [ Time Frame: Baseline to week 6 and week 11. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Contacts

Contact: Ekaterina Denkova; 3052848148; exn67@miami.edu

Locations

United States, Florida

University of Miami

Coral Gables, Florida, United States, 33146

Contact: Ekaterina Denkova 305-284-8148 exn67@miami.edu

Principal Investigator: Amishi Jha

Sponsors and Collaborators

University of Miami

United States Department of Defense

Investigators

• Principal Investigator: Amishi Jha; University of Miami

More Information

• Responsible Party: Amishi Jha, Associate Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT04703296
• Other Study ID Numbers: 20201488; W81XWH20C0065 ( Other Grant/Funding Number: Department of Defense )
• First Posted: January 11, 2021
• Last Update Posted: February 11, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amishi Jha, University of Miami:

Stress