Clinical trial NCT06775249: A Quick Mindfulness Training for an Isolated and Confined Environment
Official title: A Quick Mindfulness Training for an Isolated and Confined Environment (MINDFUL-ICE II)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Winter Crew At Concordia Station
Keywords: Isolated and Confined Environment
Mindfulness
Antarctica
Space Psychology
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
Collaborators: name: ASI Agenzia Spaziale Italiana
name: European Space Agency (ESA)
name: Programma Nazionale di Ricerche in Antartide (PNRA)
name: Institut Polaire Français Paul-Emile Victor (IPEV)
First posted: 2025-01-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will use a quasi-experimental design with a quali-quantitative approach. Specifically, two winter-over crews will receive the mindfulness training, before and during the mission (experimental group). They will be assessed for stress, mindfulness, and psychosocial adaptation during the whole mission. Results will be compared with those collected during the MINDFUL-ICE study representing the control group. Moreover, participants will be monitored during the mission for their use of the intervention and will provide qualitative data about the usability and the efficacy of the mindfulness intervention.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Winter crew at the Concordia Station, in Antarctica

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Stress
timeFrame: Up to 12 months.
Secondary outcomes:
measure: Mindful Attention
timeFrame: Up to 12 months.
measure: Langerian Mindfulness
timeFrame: Up to 12 months.
measure: Mindul Creativity
timeFrame: Up to 12 months (baseline and post-mission assessments).
Other outcomes:
measure: Program Engagement
timeFrame: Continuously during the mission, post-mission.
Locations:
city: Antarctica
country: Antarctica
facility: Concordia Station
Study officials:
References:
citation: Pagnini, F., Thoolen, S., Smith, N., Van Ombergen, A., Grosso, F., Langer, E., & Phillips, D. (2024). Mindfulness disposition as a protective factor against stress in Antarctica: A potential countermeasure for long-duration spaceflight?. Journal of Environmental Psychology, 94, 102254.