Clinical trial NCT03250156: Investigating Train the Trainer Delivery of Mindfulness-based Training
Official title: Investigating Train the Trainer Delivery of Mindfulness-based Training- Ft. Drum Soldiers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resilience
Stress
Keywords: Mindfulness
Attention
Working Memory
Psychological Well-Being
Proctored Practice
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Fort Drum
name: United States Department of Defense
First posted: 2017-08-15
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: BASIC_SCIENCE

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.

Detailed description: Background: Prior research on mindfulness training (MT) in military servicemembers showed that MT can effectively protect against degradation in attention and working memory over high-demand intervals. The benefits of MT in servicemembers were also linked to greater engagement in mindfulness practice. These prior MT programs delivered their training via a direct delivery approach, which involved a mindfulness training expert (TE) providing training to an end-user (e.g., military servicemembers). While successful, these programs are poorly suited for rapid, large-scale dissemination because these programs require direct training from a mindfulness training expert to an end-user and a considerable amount of time dedicated to training. To overcome these issues, the principal investigator together with a mindfulness expert developed a mindfulness training program contextualized for the U.S. Army, known as MBAT (Mindfulness-Based Attention Training), that is amenable to the train-the-train delivery approach and can provide rapid, large-scale dissemination to thousands of individuals. Specifically, Master Resilience Trainer - Performance Expert specialists (PEs), who have extensive experience working with soldiers but no mindfulness experience, were trained to deliver the MBAT course.

Problem: While training PEs to deliver MBAT complies with the U.S. Army time constraints, it remains unclear what is the best way to incorporate daily mindfulness practice into the duty schedule of servicemembers, which has a pivotal contribution to the protection against decline over high-demand intervals.

Project Goal: The aim of the present study is to investigate the impact of proctored vs. non-proctored practice of MBAT delivered by a PE to servicemembers. To investigate this issue, a trained PE will deliver MBAT to two groups of soldiers who will differ in the amount of duty-day support received to complete out-of-class mindfulness exercises. One group will be assigned proctored practice incorporated in the daily physical training (PT) and another group will be assigned non-proctored practice during which participants will perform the exercise independently, on their own.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Non-controlled severe medical disease that might interfere with the performance of the study.
* Any other condition the investigator might deem problematic for the inclusion of the volunteer in a trial of this nature will also be considered.

Primary outcomes:
measure: Change in Sustained Attention to Response Task (SART)
timeFrame: 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).
measure: Change in Working Memory Task with Affective Distraction (WMDA)
timeFrame: 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:
measure: Change in Positive and Negative Affect Scale (PANAS)
timeFrame: 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).
measure: Change in Perceived Stress Scale (PSS)
timeFrame: 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:
measure: Change in Connor-Davidson Resilience Score (CD-RISC)
timeFrame: 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).
measure: Change in Five-Facet Mindfulness Questionnaire (5FMQ)
timeFrame: 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).
measure: Change in Combat Experiences Scale (CES)
timeFrame: 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).
measure: Change in PTSD Checklist_Military (PCLM)
timeFrame: 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).
measure: Change in The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 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).
measure: Change in Interpersonal Reactivity Index (IRI)
timeFrame: 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).
measure: Change in Self-Compassion Scale (SCQ)
timeFrame: 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).
measure: Change in Obsessive Compulsion Index (OCI-R)
timeFrame: 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).
measure: Change in Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: 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).
measure: Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
timeFrame: 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).
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
city: Fort Drum
country: United States
facility: Ft. Drum
state: New York
Study officials:
affiliation: University of Miami
name: Amishi P Jha, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.