Mindfulness Training in Special Operations Forces (SOF) Candidates

Study Overview
=================
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).

Official Title
-----------------
Mindfulness Training in Special Operations Forces (SOF) Candidates

Conditions
-----------------
Cognitive Change

Intervention / Treatment
-----------------
* Behavioral: MBAT course


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stress