Mindfulness Training in Special Operations Forces (SOF) Candidates

Cognitive Change Clinical Trial

Official title:

Mindfulness Training in Special Operations Forces (SOF) Candidates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04703296
• Other study ID #: 20201488
• Secondary ID: W81XWH20C0065
• Status: Completed
• Phase: N/A
• Start date: March 16, 2022
• Est. completion date: January 9, 2023

Study information

• Verified date: January 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: January 9, 2023
• Est. primary completion date: December 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Change

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Coral Gables	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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)
Other	Applied Mindfulness Process Scale	Applied Mindfulness Process Scale measures how often people apply mindfulness practice in daily life.	post training at at week 6
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)