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

January 9, 2025 updated by: Francesco Pagnini, Catholic University of the Sacred Heart

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

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.

Study Overview

Status

Enrolling by invitation

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Antarctica, Antarctica
        • Concordia Station

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Winter crew at the Concordia Station, in Antarctica

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness-Based Training Program
The intervention includes a three-week pre-departure online mindfulness course with bi-weekly booster sessions during the mission. Training focuses on stress reduction and fostering psychological flexibility, openness, and creativity.
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.
No Intervention: Historical data from MINDFUL-ICE I participants
The control group comprises data collected from participants in the MINDFUL-ICE I study (an observational cohort). These participants were winter-over crew members at Concordia Station, Antarctica, during earlier missions and did not receive any mindfulness-based intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months.
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.
Up to 12 months.
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.
Up to 12 months (baseline and post-mission assessments).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

Continuously during the mission, post-mission.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

January 2, 2025

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • CERPS_12-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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