NCT03250156

Brief Summary

This project aims to evaluate the effectiveness of mindfulness training (MT) on cognitive and psychological factors when incorporated to the duty-day schedule of servicemembers (via proctored mindfulness practice). Based on prior literature, it can be hypothesized that the benefits of MT on measures of attention, working memory, and psychological well-being will be greater for servicemembers who engage in proctored mindfulness practice and receive duty-day support compared to servicemembers who practice independently, on their own time, with no structured duty day support.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

July 25, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2017

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

2 months

First QC Date

July 25, 2017

Last Update Submit

September 14, 2018

Conditions

Keywords

MindfulnessAttentionWorking MemoryPsychological Well-BeingProctored Practice

Outcome Measures

Primary Outcomes (2)

  • Change in Sustained Attention to Response Task (SART)

    The SART is used to assess attentional performance and self-reported 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 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.

    Participants will complete the SART at three time points: Pre-intervention baseline (T1), post-intervention up to 2 weeks after the end of the 4-week training (T2), and follow-up up to two months after the end of the training (T3).

  • 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 (Morey et al., 2009) and the neutral images are non-combat scenes.

    Participants will complete the WMDA at three time points: Pre-intervention baseline (T1), post-intervention up to 2 weeks after the end of the 4-week training (T2), and follow-up up to two months after the end of the training (T3).

Secondary Outcomes (2)

  • Change in Positive and Negative Affect Scale (PANAS)

    Pre-intervention baseline (T1), post-intervention up to 2 weeks after the end of the 4-week training (T2), and follow-up up to two months after the end of the training (T3).

  • Change in Perceived Stress Scale (PSS)

    Pre-intervention baseline (T1), post-intervention up to 2 weeks after the end of the 4-week training (T2), and follow-up up to two months after the end of the training (T3).

Other Outcomes (10)

  • Change in Connor-Davidson Resilience Score (CD-RISC)

    Pre-intervention baseline (T1), post-intervention up to 2 weeks after the end of the 4-week training (T2), and follow-up up to two months after the end of the training (T3).

  • Change in Five-Facet Mindfulness Questionnaire (5FMQ)

    Pre-intervention baseline (T1), post-intervention up to 2 weeks after the end of the 4-week training (T2), and follow-up up to two months after the end of the training (T3).

  • Change in Combat Experiences Scale (CES)

    Pre-intervention baseline (T1), post-intervention up to 2 weeks after the end of the 4-week training (T2), and follow-up up to two months after the end of the training (T3).

  • +7 more other outcomes

Study Arms (3)

MBAT with proctored practice

EXPERIMENTAL

Participants will engage in Mindfulness Based Attention Training (MBAT) in 4, 2-hour training classes with 1 class per week. Participants in the proctored practice group will complete assigned, out of class mindfulness exercises during the duty day - for example, as part of their daily physical training (e.g., mindful cooldown, final 15 minutes of PT is spent engaging in a mindfulness exercise using a guided recording).

Behavioral: MBAT with proctored practice

MBAT with non-proctored practice

ACTIVE COMPARATOR

Participants will engage in Mindfulness Based Attention Training (MBAT) in 4, 2-hour training classes with 1 class per week. Participants in the non-proctored practice group will complete assigned, out of class mindfulness exercises on their own time with no structured duty day support.

Behavioral: MBAT with non-proctored practice

No Training Control

NO INTERVENTION

This group will receive no intervention.

Interventions

The training program 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 four central themes: concentration, body awareness, open monitoring, and compassion. Participants will have proctored practice and complete the assigned, out-of-class mindfulness exercises during the duty day as party of their physical training.

MBAT with proctored practice

The training program 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 four central themes: concentration, body awareness, open monitoring, and compassion.Participants will not have proctored practice and will complete the assigned, out-of-class mindfulness exercises on their own.

MBAT with non-proctored practice

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English-speaking
  • Active duty military
  • Able to understand and provide signed informed consent

You may not qualify if:

  • Non-controlled severe medical disease that might interfere with the performance of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Miami

Coral Gables, Florida, 33146, United States

Location

Ft. Drum

Fort Drum, New York, 13602, United States

Location

Related Publications (4)

  • 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, 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: 25671579BACKGROUND
  • 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: 20141302BACKGROUND
  • Jha AP, Witkin JE, Morrison AB, Rostrup N, Stanley E. Short-Form Mindfulness Training Protects Against Working Memory Degradation over High-Demand Intervals. Journal of Cognitive Enhancement 2017 1(2): 154-171. doi:10.1007/s41465-017-0035-2.

    BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

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
Model Details: We aim to recruit three groups. Two groups will receive mindfulness training (MBAT) but will differ in their level of duty day support to engage in daily assigned mindfulness exercises. The Proctored group (n = 45) will receive mindfulness training and complete assigned exercises during the duty day, integrated into their daily physical training. The Non-Proctored group (n = 45) will receive identical mindfulness training, but complete their assigned exercises on their own time. These participants will not receive additional duty day support for their practice. A third group will receive no training and serve as a control group (No-Training Control, n = 45). The design relies on group randomization at the level of individual platoons. This is due to the military requirement that organic unit structure is maintained during testing and course session scheduling. The number of participants is based on prior research (Jha et al., 2017).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 25, 2017

First Posted

August 15, 2017

Study Start

July 25, 2017

Primary Completion

October 5, 2017

Study Completion

October 5, 2017

Last Updated

September 18, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations