Clinical trial NCT03310112: Mindfulness Training in U.S. Army Cohorts
Official title: Mindfulness Training in U.S. Army Cohorts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Stress
Anxiety
Post Traumatic Stress Disorder
Depression
Cognitive Change
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-10-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned into three groups: (i) a 4-week MT group (MT4, n = 40) that will receive MBAT in 4, 2-hour sessions over 4 weeks; (ii) a 2-week MT group (MT2, n = 40) that will receive MBAT in 4, 2-hour sessions over 2 weeks; (iii) a no-training control group that will be tested before and after a no-training interval (NTC4, n = 40). After the end of the course sessions, participants from the training groups will still be assigned homework exercises until third testing session (T3). Hence, the MBAT program consists of delivery of the MBAT course, including homework mindfulness practice, and followed by an interval of homework mindfulness practice without course meetings.

The design relies on group randomization at the level of individual military cohort units. This is due to the military requirement that organic unit structure can be maintained during testing and course session scheduling.
Primary purpose: BASIC_SCIENCE

Brief summary: This project aims to contextualize delivery of mindfulness training to U.S. Army personnel, evaluate its effectiveness on measures of executive functions and psychological well-being, and determine best practices for its delivery.

Detailed description: Background: An individual's success in the U.S. Army relies on many factors including the integrity of executive functions (EFs). EFs comprise a complex, multi-faceted brain system necessary to pay attention, overcome habitual and automatic behaviors, regulate mood, and ensure that current behavior is in line with short and long-term goals.Yet, protracted periods of high uncertainty, high demands, and high stress can lead to decreases in the efficiency and availability of EFs. Given the high demands and psychological vulnerabilities that U.S. Army personnel may face, it is critical to provide them with training programs to protect against degradation of EFs (particularly attention and working memory) over high-stress, high-demand intervals. Prior research on mindfulness training (MT) in civilians and military servicemembers showed that MT can effectively protect against degradation in attention and working memory and benefit psychological well-being over high-demand intervals.

Problem: While being successful, prior MT programs required a considerable amount of time dedicated to training (e.g., 24-hour training) and it is challenging to integrate these long programs into the busy schedule of the U.S. Army personnel. To accommodate the time constraints, the principal investigator together with a mindfulness expert developed a short-form mindfulness training program contextualized for the U.S. Army; the program consists of 8-hour training and is known as MBAT, Mindfulness-Based Attention Training.

Project Goal: The present study aims to investigate the best practices for delivery of a short-form mindfulness training to U.S. Army Cohorts. Specifically, the present study will examine the best delivery structure for the MBAT by comparing MBAT course delivered in 2 weeks vs. 4 weeks.

Eligibility criteria: Inclusion Criteria:

* English-speaking
* U.S. Army personnel
* Able to understand and provide signed informed consent

Exclusion Criteria

* Non-controlled sever medical disease that might interfere with the performance in the study
* Any other condition that the investigator might deem problematic for the inclusion of the volunteer in a training study of this nature

Primary outcomes:
measure: Change in Sustained Attention to Response Task (SART)
timeFrame: Change from the pre-intervention baseline (testing 1) to the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
measure: Change in Working Memory Task with Affective Distraction (WMDA)
timeFrame: Change from the pre-intervention baseline (testing 1) to the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
Secondary outcomes:
measure: Change in Patient Health Questionnaire depression scale (PHQ)
timeFrame: Change from the pre-intervention baseline (testing 1) to the immediate post-intervention (testing 2; either 2 weeks or 4 weeks according to the group) and the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
measure: Change in Generalized Anxiety Disorder assessment (GAD-7)
timeFrame: Change from the pre-intervention baseline (testing 1) to the immediate post-intervention (testing 2; either 2 weeks or 4 weeks according to the group) and the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
measure: Change in PTSD Checklist_Military (PCLM)
timeFrame: Change from the pre-intervention baseline (testing 1) to the immediate post-intervention (testing 2; either 2 weeks or 4 weeks according to the group) and the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
measure: Change in the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from the pre-intervention baseline (testing 1) to the immediate post-intervention (testing 2; either 2 weeks or 4 weeks according to the group) and the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
measure: Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
timeFrame: Change from the pre-intervention baseline (testing 1) to the immediate post-intervention (testing 2; either 2 weeks or 4 weeks according to the group) and the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
measure: Change in Brief Resilience Scale (BRS)
timeFrame: Change from the pre-intervention baseline (testing 1) to the immediate post-intervention (testing 2; either 2 weeks or 4 weeks according to the group) and the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
measure: Change in Perceived Stress Scale (PSS)
timeFrame: Change from the pre-intervention baseline (testing 1) to the immediate post-intervention (testing 2; either 2 weeks or 4 weeks according to the group) and the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
measure: Change in Positive and Negative Affect Scale (PANAS)
timeFrame: Change from the pre-intervention baseline (testing 1) to the immediate post-intervention (testing 2; either 2 weeks or 4 weeks according to the group) and the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
measure: Change in Adult Decision-Making Competence scale (Sunk Costs questionnaire)
timeFrame: Change from the pre-intervention baseline (testing 1) to the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
measure: Change in Cognitive Failures Questionnaire (CFQ)
timeFrame: Change from the pre-intervention baseline (testing 1) to the immediate post-intervention (testing 2; either 2 weeks or 4 weeks according to the group) and the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
measure: Change in Five-Facet Mindfulness Questionnaire (5FMQ)
timeFrame: Change from the pre-intervention baseline (testing 1) to the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
measure: Change in Emotion Regulation Questionnaire (ERQ)
timeFrame: Change from the pre-intervention baseline (testing 1) to the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
measure: Change in Combat Experiences Scale (CES)
timeFrame: Change from the pre-intervention baseline (testing 1) to the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
measure: Change in Rumination and Response Scale (RRS)
timeFrame: Change from the pre-intervention baseline (testing 1) to the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
measure: Change in Self-Compassion Questionnaire (SCQ)
timeFrame: Change from the pre-intervention baseline (testing 1) to the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
measure: Change in Mind Wandering Questionnaire (MWQ)
timeFrame: Change from the pre-intervention baseline (testing 1) to the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
measure: Practice logs
timeFrame: Participants will complete paper practice logs tracking their daily practice (i.e., minutes) from the beginning of the MBAT through study completion (testing 3), which is an average of 8 weeks after beginning of the intervention.
measure: Motivation
timeFrame: Participants answer the motivation questions during the long-term post-intervention (testing 3) testing session, which is an average of 8 weeks from the baseline.
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Amishi P Jha, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jha AP, Morrison AB, Dainer-Best J, Parker S, Rostrup N, Stanley EA. Minds "at attention": mindfulness training curbs attentional lapses in military cohorts. PLoS One. 2015 Feb 11;10(2):e0116889. doi: 10.1371/journal.pone.0116889. eCollection 2015.
citation: Jha, AP, Morrison, AB, Parker, SC, & Stanley, EA. Practice is protective: Mindfulness training promotes cognitive resilience in high-stress cohorts. Mindfulness. 2016; 7(1), 1-13. doi: 10.1007/s12671-015-0465-9.
citation: Jha AP, Krompinger J, Baime MJ. Mindfulness training modifies subsystems of attention. Cogn Affect Behav Neurosci. 2007 Jun;7(2):109-19. doi: 10.3758/cabn.7.2.109.
citation: Jha AP, Stanley EA, Kiyonaga A, Wong L, Gelfand L. Examining the protective effects of mindfulness training on working memory capacity and affective experience. Emotion. 2010 Feb;10(1):54-64. doi: 10.1037/a0018438.
citation: van Vugt MK, Jha AP. Investigating the impact of mindfulness meditation training on working memory: a mathematical modeling approach. Cogn Affect Behav Neurosci. 2011 Sep;11(3):344-53. doi: 10.3758/s13415-011-0048-8.
citation: Zanesco AP, Denkova E, Rogers SL, MacNulty WK, Jha AP. Mindfulness training as cognitive training in high-demand cohorts: An initial study in elite military servicemembers. Prog Brain Res. 2019;244:323-354. doi: 10.1016/bs.pbr.2018.10.001. Epub 2018 Nov 27.