UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055739 |
|---|---|
| Receipt number | R000063651 |
| Scientific Title | Developing a blief Mindfulness and Self-compassion program for health care professionals:A mixed method approach |
| Date of disclosure of the study information | 2024/10/11 |
| Last modified on | 2025/09/10 10:12:41 |
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Basic information
Public title
Developing a blief Mindfulness and Self-compassion program for health care professionals:A mixed method approach
Acronym
Developing a blief Mindfulness and Self-compassion program for health care professionals
Scientific Title
Developing a blief Mindfulness and Self-compassion program for health care professionals:A mixed method approach
Scientific Title:Acronym
Developing a blief Mindfulness and Self-compassion program for health care professionals
Region
| Japan |
Condition
Condition
health care professionals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to preliminarily examine the effectiveness of a brief combined mindfulness and self-compassion program developed for healthcare professionals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SCS-J-SF(Japanese version of the 12-item Self-Compassion Scale)
Key secondary outcomes
J-MAAS(Japanese version of the Mindful Attention Awareness Scale),SWLS(The Satisfaction With Life Scale),SHS(Subjective Happiness Scale),
JBS(Japanese Burnout Scale),Quality of patient care
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A brief combined Mindfulness and Self-compassion program for health care professionals(MSCP-HCP) is a three-week program consisting of three 90-minute sessions per session, a four-hour retreat (8.5 hours total), and home work of no more than 20 minutes each day.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Full-time medical staff (occupational therapists, physical therapists, speech therapists, clinical psychologists, licensed psychologists, doctors, nurses, administrative staff, and other medical staff involved in medical services).
2)Have not received training in mindfulness based stress reduction (MBSR) or other methods of stress reduction
Key exclusion criteria
1)Part-time or part-time worker.
2)Have a history of mental illness such as depression.
3)Currently undergoing outpatient treatment for a diagnosed mental disorder.
4)Have received training in MBSR, etc.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Hisano |
Organization
Graduate School of Prefectural University of Hiroshima
Division name
Graduate School of Comprehensive Scientific of Research
Zip code
723-0053
Address
1-1,Gakuen-cho,Mihara-City,Hiroshima
TEL
0848-60-1120
hisano@pu-hiroshima.ac.jp
Public contact
Name of contact person
| 1st name | Kotomi |
| Middle name | |
| Last name | Matsufuji |
Organization
Graduate School of Prefectural University of Hiroshima
Division name
First semester of the doctoral course, Program in Health and Welfare
Zip code
723-0053
Address
1-1,Gakuen-cho,Mihara-City,Hiroshima
TEL
0848-60-1239
Homepage URL
r424017zg@ed.pu-hiroshima.ac.jp
Sponsor or person
Institute
Prefectural University of Hiroshima
Institute
Department
Personal name
Shinya Hisano
Funding Source
Organization
Prefectural University of Hiroshima
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
Prefectural University of Hiroshima
Address
1-1,Gakuen-cho,Mihara-City,Hiroshima
Tel
0848-60-1239
hisano@pu-hiroshima.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
| 2024 | Year | 10 | Month | 11 | 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
23
Results
Quantitative data analysis revealed significant increases in the SCS-J-SF with moderate to large effect sizes between pre-intervention and post-intervention, and between post-intervention and 2 months post-intervention. SHS and JBS showed significant increases with small to moderate effect sizes between pre-intervention and 2 months post-intervention. Qualitative data analysis revealed seven concepts. Qualitative analysis findings generally supported the quantitative analysis results.
Results date posted
| 2025 | Year | 09 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The analysis included 23 participants (mean age 38.7 years, SD = 8.2; 12 women, 11 men; mean years of experience 14.6 years, SD=7.6; occupational breakdown: 20 occupational therapists, 3 clinical psychologists).
Participant flow
Twenty-four individuals participated in this program, and one dropped out.
Adverse events
Outcome measures
Self-compassion: SCS-J-SF
Mindfulness: J-MAAS
Subjective Well-being: SWLS, SHS
Burnout: JBS
Subjective experiences: Semi-structured interview
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 04 | Day |
Last modified on
| 2025 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063651
