UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061947 |
|---|---|
| Receipt number | R000070883 |
| Scientific Title | A Pilot Study on Stress Coping Ability and Group Adaptation among Human Spaceflight Program Mission Controllers |
| Date of disclosure of the study information | 2026/06/17 |
| Last modified on | 2026/06/17 19:11:17 |
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Basic information
Public title
A Pilot Study on Stress Coping Ability and Group Adaptation among Human Spaceflight Program Mission Controllers
Acronym
A Study on the Characteristics and Conditions of Space Mission Controllers
Scientific Title
A Pilot Study on Stress Coping Ability and Group Adaptation among Human Spaceflight Program Mission Controllers
Scientific Title:Acronym
A Study on the Characteristics and Conditions of Space Mission Controllers
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Through a questionnaire survey, this study aims to understand both individual characteristics such as personality traits and coping characteristics and team related characteristics, including psychological safety and conflict, among mission controllers engaged in the unique work environment of spaceflight operations, which requires multitasking, teamwork, and specialized expertise.
Basic objectives2
Others
Basic objectives -Others
By implementing an intervention program, the Salutogenic Cafe, this study aims to examine its effectiveness by investigating how individual characteristics, specifically the Sense of Coherence, which reflects stress coping ability, and work engagement, an indicator of work related well being and motivation, change following participation in the program.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sense of Coherence scale
Key secondary outcomes
Utrecht Work Engagement Scale (UWES)
Workplace Social Capital Scale
Psychological Safety Scale
Tri-Axial Coping Scale-24 (TAC-24)
Humor Coping Scale
General Health Questionnaire-12 (GHQ-12)
Athens Insomnia Scale (AIS)
Conflict-related Questions
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The Salutogenic Cafe program will be conducted. The program consists of one cycle of three sessions. The purpose of this format is to help participants gain objective insights by engaging in discussions with different members in each session.
During the sessions participants will be provided with examples of positive reframing. For example instead of saying Please be careful not to spill your coffee participants may say Please enjoy this delicious coffee until the very last sip. This approach is intended to encourage participants to consider and discuss the themes from multiple perspectives.
Participants will be assigned to either the early intervention group or the delayed intervention group, which serves as a waitlist control. Participants in Control 1 will receive the intervention first.
Interventions/Control_2
The Salutogenic Cafe program will be conducted. The program consists of one cycle of three sessions. The purpose of this format is to help participants gain objective insights by engaging in discussions with different members in each session.
During the sessions participants will be provided with examples of positive reframing. For example instead of saying Please be careful not to spill your coffee participants may say Please enjoy this delicious coffee until the very last sip. This approach is intended to encourage participants to consider and discuss the themes from multiple perspectives.
Participants will be assigned to either the early intervention group or Control 2, the delayed intervention group. Participants in Control 2 will receive the intervention after the waiting period.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults aged 18 years or older
Key exclusion criteria
Not applicable
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shin-ichiro |
| Middle name | |
| Last name | Sasahara |
Organization
University of Tsukuba
Division name
Institute of Medicine, Occupational and Aerospace Psychiatry Group
Zip code
305-8575
Address
Occupational and Aerospace Psychiatry Group, Tennodai 1-1-1 , Tsukuba, Ibaraki , Japan
TEL
029-853-6025
s-sshara@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Shin-ichiro |
| Middle name | |
| Last name | Sasahara |
Organization
University of Tsukuba
Division name
Institute of Medicine, Occupational and Aerospace Psychiatry Group
Zip code
305-8575
Address
Occupational and Aerospace Psychiatry Group, Tennodai 1-1-1 , Tsukuba, Ibaraki , Japan
TEL
029-853-6025
Homepage URL
s-sshara@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba Medical Ethics Committee
Address
Tennodai 1-1-1 , Tsukuba, Ibaraki , Japan
Tel
029-853-3545
t-credo.adm@un.tsukuba.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
36
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 17 | Day |
Last modified on
| 2026 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070883
