- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06775249
A Quick Mindfulness Training for an Isolated and Confined Environment (MINDFUL-ICE II)
A Quick Mindfulness Training for an Isolated and Confined Environment (MINDFUL-ICE II)
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Antarctica, Antarctica
- Concordia Station
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Winter crew at the Concordia Station, in Antarctica
Exclusion Criteria:
- N/A
Study Plan
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 |
|---|---|
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stress
Time Frame: Up to 12 months.
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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.
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Up to 12 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mindful Attention
Time Frame: Up to 12 months.
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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.
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Up to 12 months.
|
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Langerian Mindfulness
Time Frame: Up to 12 months.
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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.
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Up to 12 months.
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Mindul Creativity
Time Frame: Up to 12 months (baseline and post-mission assessments).
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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.
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Up to 12 months (baseline and post-mission assessments).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Program Engagement
Time Frame: Continuously during the mission, post-mission.
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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.
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Collaborators and Investigators
Publications and helpful links
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
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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