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Mindfulness Training in U.S. Army Cohorts

Primary Purpose

Psychological Stress, Anxiety, Post Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
4-week MBAT
2-week MBAT
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psychological Stress

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

4-week MBAT

2-week MBAT

No training control (NTC)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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 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.

Secondary Outcome Measures

Change in Patient Health Questionnaire depression scale (PHQ)
PHQ is used as a valid diagnostic and severity measure for depressive disorders.
Change in Generalized Anxiety Disorder assessment (GAD-7)
GAD is used as a screening tool and severity measure for generalized anxiety disorder.
Change in PTSD Checklist_Military (PCLM)
PCLM assesses the symptoms of Post-Traumatic Stress Disorder in military personnel.
Change in the Pittsburgh Sleep Quality Index (PSQI)
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.
Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
AUDIT-C allows to identify people who are hazardous drinkers or have active alcohol use disorders.
Change in Brief Resilience Scale (BRS)
BRS assesses the ability to bounce back or recover from stress.
Change in Perceived Stress Scale (PSS)
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.
Change in Positive and Negative Affect Scale (PANAS)
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.
Change in Adult Decision-Making Competence scale (Sunk Costs questionnaire)
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.
Change in Cognitive Failures Questionnaire (CFQ)
CFQ assesses the frequency of committing minor, everyday mistakes.
Change in Five-Facet Mindfulness Questionnaire (5FMQ)
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.
Change in Emotion Regulation Questionnaire (ERQ)
ERQ assesses individual differences in two emotion regulation strategies: expressive suppression and cognitive reappraisal.
Change in Combat Experiences Scale (CES)
CES assesses how many different experiences someone had while deployed and in combat.
Change in Rumination and Response Scale (RRS)
RRS assesses two aspects of rumination: brooding and reflective pondering
Change in Self-Compassion Questionnaire (SCQ)
SCQ assesses various facets of self-compassion
Change in Mind Wandering Questionnaire (MWQ)
MWQ assesses common experiences related to distraction and mind-wandering.
Practice logs
Practice logs will be used to keep track of participants daily mindfulness practice.
Motivation
Five questions regarding motivation to complete the testing session

Full Information

First Posted
October 3, 2017
Last Updated
September 14, 2018
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT03310112
Brief Title
Mindfulness Training in U.S. Army Cohorts
Official Title
Mindfulness Training in U.S. Army Cohorts
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 9, 2017 (Actual)
Primary Completion Date
March 27, 2018 (Actual)
Study Completion Date
March 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress, Anxiety, Post Traumatic Stress Disorder, Depression, Cognitive Change

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4-week MBAT
Arm Type
Experimental
Arm Description
Participants will engage in Mindfulness-Based Attention Training (MBAT) in 4, 2-hour training classes over 4 weeks.
Arm Title
2-week MBAT
Arm Type
Active Comparator
Arm Description
Participants will engage in Mindfulness-Based Attention Training (MBAT) in 4, 2-hour training classes over 2 weeks.
Arm Title
No training control (NTC)
Arm Type
No Intervention
Arm Description
Participants will receive no intervention but will be tested before and after a no-training interval.
Intervention Type
Behavioral
Intervention Name(s)
4-week MBAT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
2-week MBAT
Intervention Description
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 Outcome Measure Information:
Title
Change in Sustained Attention to Response Task (SART)
Description
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.
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.
Title
Change in Working Memory Task with Affective Distraction (WMDA)
Description
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.
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.
Secondary Outcome Measure Information:
Title
Change in Patient Health Questionnaire depression scale (PHQ)
Description
PHQ is used as a valid diagnostic and severity measure for depressive disorders.
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.
Title
Change in Generalized Anxiety Disorder assessment (GAD-7)
Description
GAD is used as a screening tool and severity measure for generalized anxiety disorder.
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.
Title
Change in PTSD Checklist_Military (PCLM)
Description
PCLM assesses the symptoms of Post-Traumatic Stress Disorder in military personnel.
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.
Title
Change in the Pittsburgh Sleep Quality Index (PSQI)
Description
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.
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.
Title
Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
Description
AUDIT-C allows to identify people who are hazardous drinkers or have active alcohol use disorders.
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.
Title
Change in Brief Resilience Scale (BRS)
Description
BRS assesses the ability to bounce back or recover from stress.
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.
Title
Change in Perceived Stress Scale (PSS)
Description
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.
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.
Title
Change in Positive and Negative Affect Scale (PANAS)
Description
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.
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.
Title
Change in Adult Decision-Making Competence scale (Sunk Costs questionnaire)
Description
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.
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.
Title
Change in Cognitive Failures Questionnaire (CFQ)
Description
CFQ assesses the frequency of committing minor, everyday mistakes.
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.
Title
Change in Five-Facet Mindfulness Questionnaire (5FMQ)
Description
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.
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.
Title
Change in Emotion Regulation Questionnaire (ERQ)
Description
ERQ assesses individual differences in two emotion regulation strategies: expressive suppression and cognitive reappraisal.
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.
Title
Change in Combat Experiences Scale (CES)
Description
CES assesses how many different experiences someone had while deployed and in combat.
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.
Title
Change in Rumination and Response Scale (RRS)
Description
RRS assesses two aspects of rumination: brooding and reflective pondering
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.
Title
Change in Self-Compassion Questionnaire (SCQ)
Description
SCQ assesses various facets of self-compassion
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.
Title
Change in Mind Wandering Questionnaire (MWQ)
Description
MWQ assesses common experiences related to distraction and mind-wandering.
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.
Title
Practice logs
Description
Practice logs will be used to keep track of participants daily mindfulness practice.
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.
Title
Motivation
Description
Five questions regarding motivation to complete the testing session
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amishi P Jha, Ph.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25671579
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
17672382
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.
Results Reference
background
PubMed Identifier
20141302
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.
Results Reference
background
PubMed Identifier
21732031
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.
Results Reference
background
PubMed Identifier
30732844
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.
Results Reference
derived

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Mindfulness Training in U.S. Army Cohorts

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