Winter Crew At Concordia StationMINDFUL-ICE IINCT06775249
A Quick Mindfulness Training for an Isolated and Confined Environment
A study testing ICE Mindfulness Program in people with Winter Crew At Concordia Station, run by Catholic University of the Sacred Heart at 1 site in Antarctica.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Winter Crew At Concordia Station
- What is being tested?
- ICE Mindfulness Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAntarctica
- Study dates
- 8 Oct 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Winter crew at the Concordia Station, in Antarctica
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Antarctica1 site
Concordia Station
Antarctica
About this study
Official title: 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.
Read the 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.
- Conditions
- Winter Crew At Concordia Station
- Being tested
- ICE Mindfulness Program
- Keywords
- Isolated and Confined Environment, Mindfulness, Antarctica, Space Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICE Mindfulness ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Training Program | Experimental | 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. Receives: Behavioral: ICE Mindfulness Program |
| Historical data from MINDFUL-ICE I participants | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Stress
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.
Measured: Up to 12 months.
Secondary outcomes (3)
Mindful Attention
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.
Measured: Up to 12 months.
Langerian Mindfulness
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.
Measured: Up to 12 months.
Mindul Creativity
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.
Measured: Up to 12 months (baseline and post-mission assessments).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start8 Oct 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Winter Crew At Concordia StationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- ASI Agenzia Spaziale Italiana, European Space Agency (ESA), Programma Nazionale di Ricerche in Antartide (PNRA), Institut Polaire Français Paul-Emile Victor (IPEV)
- Responsible party
- Principal investigator, Francesco Pagnini, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775249
- Sponsor's protocol ID
- CERPS_12-24
- Acronym
- MINDFUL-ICE II
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quick Mindfulness Training for an Isolated and Confined Environment (MINDFUL-ICE II)
- ClinicalTrials.gov ID
- NCT06775249
- Acronym / sponsor ID
- MINDFUL-ICE II / CERPS_12-24
- Conditions
- Winter Crew At Concordia Station
- Keywords
- Isolated and Confined Environment, Mindfulness, Antarctica, Space Psychology
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- ASI Agenzia Spaziale Italiana, European Space Agency (ESA), Programma Nazionale di Ricerche in Antartide (PNRA), Institut Polaire Français Paul-Emile Victor (IPEV)
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Training Program | Experimental | Behavioral: ICE Mindfulness ProgramThe 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. |
| Historical data from MINDFUL-ICE I participants | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Winter crew at the Concordia Station, in Antarctica
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICE Mindfulness ProgramThe 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. | Behavioural | Mindfulness-Based Training Program |
Primary outcome
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.
3 secondary outcomes
Mindful Attention
Time frame: Up to 12 months.
Langerian Mindfulness
Time frame: Up to 12 months.
Mindul Creativity
Time frame: Up to 12 months (baseline and post-mission assessments).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- BackgroundPagnini, 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICE Mindfulness Program in people with Winter Crew At Concordia Station, run by Catholic University of the Sacred Heart at 1 site in Antarctica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Antarctica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress (time frame: Up to 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06775249, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.