NCT06775249

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Oct 2024Oct 2026

Study Start

First participant enrolled

October 8, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

January 2, 2025

Last Update Submit

January 9, 2025

Conditions

Keywords

Isolated and Confined EnvironmentMindfulnessAntarcticaSpace Psychology

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 12 months.

Secondary Outcomes (3)

  • Mindful Attention

    Up to 12 months.

  • Langerian Mindfulness

    Up to 12 months.

  • Mindul Creativity

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

Other Outcomes (1)

  • Program Engagement

    Continuously during the mission, post-mission.

Study Arms (2)

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.

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.

Interventions

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.

Mindfulness-Based Training Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Winter crew at the Concordia Station, in Antarctica

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Concordia Station

Antarctica, Antarctica

Location

Related Publications (1)

  • 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.

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Psychology

Study Record Dates

First Submitted

January 2, 2025

First Posted

January 15, 2025

Study Start

October 8, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

January 15, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations