- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03310112
Mindfulness Training in U.S. Army Cohorts
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Coral Gables, Florida, United States, 33146
- University of Miami
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 4-week MBAT
Participants will engage in Mindfulness-Based Attention Training (MBAT) in 4, 2-hour training classes over 4 weeks.
|
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.
|
|
Active Comparator: 2-week MBAT
Participants will engage in Mindfulness-Based Attention Training (MBAT) in 4, 2-hour training classes over 2 weeks.
|
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.
|
|
No Intervention: No training control (NTC)
Participants will receive no intervention but will be tested before and after a no-training interval.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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)
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.
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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)
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.
|
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)
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.
|
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)
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.
|
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)
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.
|
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 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.
|
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 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.
|
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 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.
|
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 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.
|
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 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.
|
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 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.
|
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 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.
|
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 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.
|
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 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
|
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 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
|
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 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.
|
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.
|
|
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.
|
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.
|
|
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
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amishi P Jha, Ph.D., University of Miami
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20170243
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
Massachusetts General HospitalRecruitingDepression | Depression - Major Depressive Disorder | Depression Chronic | Depression in Adults | Depression Disorders | Depression DisorderUnited States
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Active, not recruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
ProgenaBiomeWithdrawnDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RecruitingAnxiety | Anxiety Depression | Depression Anxiety Disorder | Depression - Major Depressive DisorderNorway
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Lipocine Inc.CompletedDepression, Postpartum | Postnatal Depression | Peripartum Depression | Depression, Post-Partum | Postpartum Depression (PPD) | Post-Natal DepressionUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryActive, not recruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Kolby Walker, DO; Brittany KimbleRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of CincinnatiNational Center for Complementary and Integrative Health (NCCIH)RecruitingMild DepressionUnited States
-
Fondation FondaMentalGYNOVNot yet recruitingDepression | Depression in Adults | Depression DisorderFrance
Clinical Trials on 4-week MBAT
-
University of MiamiUnited States Department of DefenseCompleted
-
University of PennsylvaniaAdvanced Medical ElectronicsCompleted
-
University of MiamiUnited States Department of Defense; Fort DrumCompletedStress | ResilienceUnited States
-
University of MiamiUnited States Department of DefenseCompleted
-
Pamela Gonzalez Sr Director Clinical Research OfficeCompletedInpatient Attending Physician Staffing ModelUnited States
-
International Centre for Diarrhoeal Disease Research...Completed
-
Töölö HospitalTampere University HospitalCompletedAnkle Fracture | Postoperative Treatment
-
Macao Polytechnic UniversityRecruitingHigh-altitude Training Adaptations in Adolescent Male RowersChina
-
University of MiamiUnited States Department of DefenseTerminated