Clinical trial NCT04703296: Mindfulness Training in Special Operations Forces (SOF) Candidates
Official title: Mindfulness Training in Special Operations Forces (SOF) Candidates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Keywords: Stress
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2021-01-11
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


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.

Primary outcomes:
measure: Change in Attentional Performance
timeFrame: Baseline (week 1) to week 6 (after 4-week training interval)
measure: Change in Working Memory Performance
timeFrame: Baseline (week 1) to week 6 (after 4-week training interval)
measure: Change in Cognitive Failures
timeFrame: Baseline (week 1) to week 6 (after 4-week training interval)
Secondary outcomes:
measure: Change in Positive Affect
timeFrame: Baseline (week 1) to week 6 (after 4-week training interval)
measure: Change in Negative Affect
timeFrame: Baseline (week 1) to week 6 (after 4-week training interval)
measure: Change in Perceived Stress
timeFrame: Baseline (week 1) to week 6 (after 4-week training interval)
measure: Change in Psychological Health
timeFrame: Baseline (week 1) to week 6 (after 4-week training interval)
measure: Change in Decentering
timeFrame: Baseline (week 1) to week 6 (after 4-week training interval)
measure: Change in Mind Wandering
timeFrame: Baseline (week 1) to week 6 (after 4-week training interval)
Other outcomes:
measure: Change in Post-Traumatic Stress Disorder (PTSD) symptomatology
timeFrame: Baseline to week 6 and week 11.
measure: Change in Perspective Taking
timeFrame: Baseline (week 1) to week 6 (after 4-week training interval)
measure: Applied Mindfulness Process Scale
timeFrame: post training at at week 6
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Amishi Jha
role: PRINCIPAL_INVESTIGATOR
References: