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Completed

NCT Number: NCT03310112

Mindfulness Training in U.S. Army Cohorts

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.

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Key information

Conditions

Psychological Stress Anxiety Anxiety Disorders Behavior Behavioral Symptoms Cognitive Change Depression Mental Disorders Post Traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Stress, Psychological Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Coral Gables, Florida, 33146, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Sustained Attention to Response Task (SART)

    Time frame: 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.

    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.

  2. Change in Working Memory Task with Affective Distraction (WMDA)

    Time frame: 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.

    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.

Secondary outcomes

  1. Change in Patient Health Questionnaire depression scale (PHQ)

    Time frame: 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.

    PHQ is used as a valid diagnostic and severity measure for depressive disorders.

  2. Change in Generalized Anxiety Disorder assessment (GAD-7)

    Time frame: 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.

    GAD is used as a screening tool and severity measure for generalized anxiety disorder.

  3. Change in PTSD Checklist_Military (PCLM)

    Time frame: 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.

    PCLM assesses the symptoms of Post-Traumatic Stress Disorder in military personnel.

  4. Change in the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

    PSQI assesses sleep quality and disturbances in seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.

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

    Time frame: 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.

    AUDIT-C allows to identify people who are hazardous drinkers or have active alcohol use disorders.

  6. Change in Brief Resilience Scale (BRS)

    Time frame: 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.

    BRS assesses the ability to bounce back or recover from stress.

  7. Change in Perceived Stress Scale (PSS)

    Time frame: 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.

    PSS assesses the degree to which situations in one's life are viewed as stressful within the past month. Individual items assess feelings of stress, nervousness, irritation at life's hassles, and perceptions of one's own coping and control over a situation.

  8. Change in Positive and Negative Affect Scale (PANAS)

    Time frame: 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.

    PANAS assesses positive and negative affect. It consists of a list of descriptors of positive (e.g., 'interested', 'enthusiastic') and negative (e.g., 'irritable', 'upset') affects. Items are rated on a 5-point scale (1 = very slightly or not at all, 5 = extremely), according to how participants feel. The Positive Affect scale reflects the extent to which a person feels enthusiastic, active, and alert; the Negative Affect scale reflects unpleasant mood states, such as anger, disgust, and fear.

  9. Change in Adult Decision-Making Competence scale (Sunk Costs questionnaire)

    Time frame: 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.

    Sunk Costs assesses resistance to framing, recognizing social norms, under/overconfidence, applying decision rules, risk perception, resistance to sunk costs, and path independence. A variant of this measure assessing resistance to sunk costs in a military context may be used.

  10. Change in Cognitive Failures Questionnaire (CFQ)

    Time frame: 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.

    CFQ assesses the frequency of committing minor, everyday mistakes.

  11. Change in Five-Facet Mindfulness Questionnaire (5FMQ)

    Time frame: 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.

    5FMQ assesses five major measures of mindfulness, including non-judgment of experience, non-reactivity to inner experience, observing emotions, acting with awareness, and describing feelings in words.

  12. Change in Emotion Regulation Questionnaire (ERQ)

    Time frame: 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.

    ERQ assesses individual differences in two emotion regulation strategies: expressive suppression and cognitive reappraisal.

  13. Change in Combat Experiences Scale (CES)

    Time frame: 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.

    CES assesses how many different experiences someone had while deployed and in combat.

  14. Change in Rumination and Response Scale (RRS)

    Time frame: 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.

    RRS assesses two aspects of rumination: brooding and reflective pondering

  15. Change in Self-Compassion Questionnaire (SCQ)

    Time frame: 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.

    SCQ assesses various facets of self-compassion

  16. Change in Mind Wandering Questionnaire (MWQ)

    Time frame: 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.

    MWQ assesses common experiences related to distraction and mind-wandering.

  17. Practice logs

    Time frame: 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.

    Practice logs will be used to keep track of participants daily mindfulness practice.

  18. Motivation

    Time frame: 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.

    Five questions regarding motivation to complete the testing session

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 16, 2017
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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