Enrolling by Invitation

NCT Number: NCT06775249

A Quick Mindfulness Training for an Isolated and Confined Environment

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.

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Key information

Conditions

Winter Crew At Concordia Station

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Concordia Station

Antarctica

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Winter crew at the Concordia Station, in Antarctica

Exclusion criteria

Treatment and study plan

ICE Mindfulness Program

Behavioral

The ICE Mindfulness Program is a tailored, self-paced intervention designed for crew members in isolated and confined environments. It includes a three-week pre-departure online course with videos, audio, and cognitive exercises promoting mindfulness, flexibility, and creativity, requiring 15-30 minutes daily. Delivered via email, it blends elements from Mindfulness-Based Stress Reduction and the Langerian approach. Participants receive new content daily, focusing on stress reduction and adaptation in extreme settings. Pre-departure, the PI leads a 1.5-hour interactive session with group meditation. During the mission, bi-weekly booster sessions are conducted by the ESA MD, supplemented by ongoing access to training materials. Exercises include meditations, mindful discussions, and cognitive tasks, with flexibility to fit participant schedules. The program will be available in Italian, French, and English.

Primary outcomes

Stress

Time frame: 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.

Secondary outcomes

Mindful Attention

Time frame: Up to 12 months.

The Mindful Attention Awareness Scale: A 15-item self-report measure designed to assess a core characteristic of mindfulness, namely one's receptive awareness of and attention to what is taking place in the present. It has been validated in multiple languages, including Italian and French. The measure takes 5 minutes or less to complete. Based on a mean of all items, MAAS scores can range from 1 to 6. Higher scores indicate greater mindfulness.
Langerian Mindfulness

Time frame: Up to 12 months.

The Langer Mindfulness Scale: A 21-item questionnaire that assesses three domains describing mindful thinking: novelty seeking, engagement, flexibility, and novelty producing. It has been translated and validated in Italian, and the French validation is currently ongoing. The LMS can be completed in less than 5 minutes. The score ranges from to 21 to 147, with higher scores reflecting higher mindfulness.
Mindul Creativity

Time frame: Up to 12 months (baseline and post-mission assessments).

The Triangle Task assesses creative mindful thinking by asking participants to identify connections between abstract and concrete concepts (e.g., a "triangle" and related items). Scores reflect cognitive flexibility and openness. Scores range from 0 to 50, with higher scores reflecting higher mindful creativity.

Other outcomes

Program Engagement

Time frame: Continuously during the mission, post-mission.

The usage of the mindfulness exercises and other contents from the program will be continually monitored by (anonymously) tracking the access to the platform and with open-ended questions at every assessment time. These open-ended questions will ask how the participants used the mindfulness exercises and how they applied any mindset changes suggested by the training.

An in-depth interview via video-call will be scheduled at the end of the mission to explore the perceived usefulness of the program and the qualitative impact of its contents. For example, participants will be asked if and how they applied contents and strategies from the program. They will also be asked how they dealt with possible crises, and whether they discussed some program contents with the fellow crewmembers.

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Collaborators

ASI Agenzia Spaziale Italiana
European Space Agency (ESA)
Institut Polaire Français Paul-Emile Victor (IPEV)
Programma Nazionale di Ricerche in Antartide (PNRA)

Registry information

Official study title

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

Acronym: MINDFUL-ICE II

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Jan 15, 2025
Registry last updated: Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.