Mindfulness Training in U.S. Army Cohorts

NCT03310112 | Completed

• 1 other identifier: 20170243
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Stress; Anxiety; Post Traumatic Stress Disorder; Depression; Cognitive Change

Outcome Measures

Primary Outcomes (2)

• Change in Sustained Attention to Response Task (SART)

  The SART is used to assess attentional performance and mind wandering (i.e., off-task thinking which is typically self-generated and compromises the performance of the task at hand). The task uses a continuous performance paradigm involving button presses to frequently presented non-targets (numbers 1, 2, 4, 5, 6, 7, 8, and 9) but requires the participants to withhold their motor response to the infrequent target (number 3). Withholding responses only to infrequent targets encourages a pre-potent response and mind wandering. Real-time subjective experience of mind wandering during SART is assessed through experience-sampling probes randomly presented throughout the task.

  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.

• Change in Working Memory Task with Affective Distraction (WMDA)

  The WMDA is used to assess the ability to hold information in working memory while overcoming emotional reactivity and distraction. Specifically, participants are presented with a memory item that they need to memorize and hold in memory during a delay interval. During the delay, emotionally negative or neutral scene images are presented. The negative images are combat scenes from Iraq or Afghanistan and the neutral images are non-combat scenes.

  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 (18)

• Change in Patient Health Questionnaire depression scale (PHQ)

  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.

• Change in Generalized Anxiety Disorder assessment (GAD-7)

  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.

• Change in PTSD Checklist_Military (PCLM)

  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.

• Change in the Pittsburgh Sleep Quality Index (PSQI)

  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.

• Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)

  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.

Study Arms (3)

4-week MBAT

EXPERIMENTAL

Participants will engage in Mindfulness-Based Attention Training (MBAT) in 4, 2-hour training classes over 4 weeks.

Behavioral: 4-week MBAT

2-week MBAT

ACTIVE COMPARATOR

Participants will engage in Mindfulness-Based Attention Training (MBAT) in 4, 2-hour training classes over 2 weeks.

Behavioral: 2-week MBAT

No training control (NTC)

NO INTERVENTION

Participants will receive no intervention but will be tested before and after a no-training interval.

Interventions

4-week MBAT BEHAVIORAL

The training is known as Mindfulness-Based Attention Training, or MBAT. The MBAT program is based on the principles of Mindfulness-Based Stress Reduction, but contextualized for military personnel using themes relevant to military life. The training content is comprised of four central themes: concentration, body awareness, open monitoring, and compassion. This content will be delivered in 4, 2-hour sessions over 4 weeks. Participants will be assigned homework mindfulness practice during the interval of course delivery as well as for the few weeks following the end of the course.

4-week MBAT

2-week MBAT BEHAVIORAL

The training is known as Mindfulness-Based Attention Training, or MBAT. The MBAT program is based on the principles of Mindfulness-Based Stress Reduction, but contextualized for military personnel using themes relevant to military life. The training content is comprised of four central themes: concentration, body awareness, open monitoring, and compassion. This content will be delivered in 4, 2-hour sessions over 2 weeks. Participants will be assigned homework mindfulness practice during the interval of course delivery as well as for the few weeks following the end of the course.

2-week MBAT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Non-controlled sever medical disease that might interfere with the performance in the study

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

Related Publications (6)

• 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.

  PMID: 25671579 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 17672382 BACKGROUND

• 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.

  PMID: 20141302 BACKGROUND

• 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.

  PMID: 21732031 BACKGROUND

• 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.

  PMID: 30732844 DERIVED

MeSH Terms

Conditions

Stress, Psychological; Anxiety Disorders; Stress Disorders, Post-Traumatic; Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Amishi P Jha, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 16, 2017
• Study Start: October 9, 2017
• Primary Completion: March 27, 2018
• Study Completion: March 27, 2018
• Last Updated: September 18, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)