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临床试验/NCT06775249
NCT06775249
Enrolling By Invitation
不适用

A Quick Mindfulness Training for an Isolated and Confined Environment (MINDFUL-ICE II)

Catholic University of the Sacred Heart1 个研究点 分布在 1 个国家目标入组 24 人2024年10月8日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
未指定
发起方
Catholic University of the Sacred Heart
入组人数
24
试验地点
1
主要终点
Stress
状态
Enrolling By Invitation
最后更新
去年

概览

简要总结

The MINDFUL-ICE II project explores the significance of mindfulness as a psychological trait crucial for extended missions in isolated and confined environments (ICEs). Previous data from the MINDFUL-ICE study with Concordia base crews validated a link between dispositional mindfulness and reduced stress. However, the efficacy of a mindfulness-based intervention in mitigating distress and fostering psychological adaptation within such environments remains untested. This project aims to assess a specific mindfulness training program's efficacy, feasibility, and usability for Concordia base crews over a two-year assignment. The pre-departure online mindfulness training, tailored for the pre-mission period, will feature minimal time commitments. Bi-weekly booster sessions during the mission, conducted by the ESA MD, will support the training. Using a quasi-experimental design, crews receiving this intervention will be compared with the first MINDFUL-ICE study's results. Stress, mindfulness, and psychological data will be tracked throughout the winter-over mission, aligning with the assessment approach of the initial study. Participants will report program usage, acquired knowledge, and engage in post-mission qualitative interviews. Both quantitative and qualitative findings will be crucial in gauging the intervention's effectiveness and usability for future long-duration and ICE space missions.

详细描述

Long-duration space missions introduce unique stressors, including isolation, confinement, communication delays, and environmental monotony, which can negatively affect mood, cognition, and performance. This study addresses the need for countermeasures by testing a mindfulness-based training program developed specifically for such environments. The intervention includes: Pre-departure Training: A three-week, self-paced online course delivered via the Qualtrics platform, featuring videos, audio content, and exercises. Participants engage in daily activities averaging 15-30 minutes, focusing on mindfulness principles such as awareness, flexibility, and creativity. Mission Phase: Bi-weekly booster sessions led by the ESA physician, supplemented by ongoing access to training materials. Content is tailored to address the challenges of ICE settings and can be accessed on-demand. Assessment: Stress and mindfulness levels are measured at multiple time points (pre-departure, mid-mission, and post-mission). Additional qualitative feedback will explore participant experiences, training usability, and psychological adaptation. The quasi-experimental design compares the outcomes of MINDFUL-ICE II participants with data from the previous observational MINDFUL-ICE study, which serves as a control group. This approach leverages matched cohorts to evaluate the program's efficacy in reducing stress and fostering adaptive psychological responses. Data will be collected using validated psychometric tools, including the Perceived Stress Scale (PSS), Mindful Attention Awareness Scale (MAAS), and Langer Mindfulness Scale (LMS), alongside qualitative interviews and thematic analysis. Insights gained will contribute to the development of psychological interventions for future space exploration missions and other high-stress, isolated environments.

注册库
clinicaltrials.gov
开始日期
2024年10月8日
结束日期
2026年10月
最后更新
去年
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Francesco Pagnini

Professor of Clinical Psychology

Catholic University of the Sacred Heart

入排标准

入选标准

  • Winter crew at the Concordia Station, in Antarctica

排除标准

  • 未提供

结局指标

主要结局

Stress

时间窗: Up to 12 months.

Stress will be assessed using the Perceived Stress Scale, a validated 10-item self-report measure. Individual scores on the scale can range from 0 to 40 with higher scores indicating higher perceived.

次要结局

  • Mindful Attention(Up to 12 months.)
  • Langerian Mindfulness(Up to 12 months.)
  • Mindul Creativity(Up to 12 months (baseline and post-mission assessments).)

研究点 (1)

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