跳至主要内容
临床试验/NCT03310112
NCT03310112已完成不适用

Mindfulness Training in U.S. Army Cohorts

University of Miami2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年10月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Change in Working Memory Task with Affective Distraction (WMDA)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Change in Working Memory Task with Affective Distraction (WMDA)

时间窗: 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 in Sustained Attention to Response Task (SART)

时间窗: 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.

次要结局

  • Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)(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)(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 Patient Health Questionnaire depression scale (PHQ)(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)(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)(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)(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)(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)(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)(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(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.)
  • Change in Perceived Stress Scale (PSS)(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 Rumination and Response Scale (RRS)(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 Positive and Negative Affect Scale (PANAS)(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 Cognitive Failures Questionnaire (CFQ)(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 Combat Experiences Scale (CES)(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)(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)(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.)
  • Motivation(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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amishi Jha

Associate Professor

University of Miami

研究点 (2)

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