UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057217 |
|---|---|
| Receipt number | R000065396 |
| Scientific Title | The feasibility study of the mindfulness-based therapy workshop (Teaching Foundation) for healthcare professionals. |
| Date of disclosure of the study information | 2025/03/05 |
| Last modified on | 2025/03/05 20:19:17 |
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Basic information
Public title
The feasibility study of the mindfulness-based therapy workshop (Teaching Foundation) for healthcare professionals.
Acronym
The feasibility study of the mindfulness-based therapy workshop for healthcare professionals.
Scientific Title
The feasibility study of the mindfulness-based therapy workshop (Teaching Foundation) for healthcare professionals.
Scientific Title:Acronym
The feasibility study of the mindfulness-based therapy workshop for healthcare professionals.
Region
| Japan |
Condition
Condition
healthcare professionals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility of the mindfulness-based therapy workshop (Teaching Foundation) for healthcare professionals.
Basic objectives2
Others
Basic objectives -Others
feasibility
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Since this study is a feasibility study, the primary outcome measures are:
Recruitment rate,
Dropout rate,
Program attendance rate, and
Average time spent on homework, including their mean values and standard deviations.
Specifically:
Recruitment rate is defined as the proportion of applicants who were successfully enrolled in the study.
Dropout rate refers to the proportion of enrolled participants who attended fewer than three out of the four program days.
Program attendance rate represents the actual attendance rate of the program.
Homework time is defined as the amount of time participants spent on recommended meditation and inquiry practices between the first and second halves of the workshop.
Key secondary outcomes
The study will assess the mean values and standard deviations at both baseline (pre-workshop) and post-workshop, as well as the mean change scores and their standard errors for the following measures:
-Measures of acceptability, appropriateness, and feasibility of the intervention:
Acceptability of Intervention Measure (AIM)
Intervention Appropriateness Measure (IAM)
Feasibility of Intervention Measure (FIM)
-Measures of mindfulness skills:
Five Facet Mindfulness Questionnaire (FFMQ)
Experience Questionnaire (EQ)
-Measure of work engagement:
Utrecht Work Engagement Scale (UWES)
-Measures of well-being:
Satisfaction With Life Scale (SWLS)
Flourishing Scale (FS)
Scale of Positive and Negative Experience (SPANE)
ICEpop CAPability measure for Adults (ICECAP-A)
-Measure of stress:
Perceived Stress Scale (PSS)
-Other measures:
Adverse event scale
Meditation practice
Meditation instruction
Time spent on inquiry practice
A comparison of mean values before and after the workshop will be conducted.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Mindfulness-Based Therapy Workshop (Teaching Foundation)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. have at least two years of experience in mental health care and be primarily employed at a medical institution as a physician, nurse, public health nurse, psychiatric social worker, licensed psychologist, or clinical psychologist.
2. have previously completed a mindfulness-based therapy program, such as the basic workshop for the mindfulness based program, Mindfulness-Based Cognitive Therapy (MBCT), or Mindfulness-Based Stress Reduction (MBSR), or possess equivalent experience.
3. be able to participate in both the first half (two days) and the second half (two days) of the Teaching Foundation Workshop, as well as complete the self-report questionnaires administered during the workshop.
4. be able to engage in ongoing meditation and other assigned practices between the first and second halves of the workshop.
5. be in good physical and mental health to perform regular work duties.
6. be able to obtain a recommendation from a workplace supervisor at the time of application.
7. be able to provide informed consent to participate in the study.
Note: After receiving the acceptance notification, participants will be required to submit a recommendation letter signed and stamped by their recommender.
Key exclusion criteria
1. Individuals whom the principal investigator deems inappropriate for inclusion in the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Sado |
Organization
Keio University
Division name
Department of Neuropsychiatry, School of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
0333531211
mitsusado@keio.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Sado |
Organization
Keio University
Division name
Department of Neuropsychiatry, School of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
0333531211
Homepage URL
mitsusado@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Mitsuhiro Sado
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
0333531211
med-rinri-jimu@adst.keio.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
| 2025 | Year | 03 | Month | 05 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 05 | Day |
Last modified on
| 2025 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065396
