UMIN-CTR Clinical Trial

Public title

Feasibility study of the basic workshop for the mindfulness based program for healthcare professionals

Acronym

Feasibility study of the basic workshop for the mindfulness based program for healthcare professionals

Scientific Title

Feasibility study of the basic workshop for the mindfulness based program for healthcare professionals

Scientific Title:Acronym

Feasibility study of the basic workshop for the mindfulness based program for healthcare professionals

Region

Japan

Condition

healthcare professionals

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess the feasibility of the basic workshop of the mindfulness based program for the healthcare professionals.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I

Primary outcomes

Since this is a feasibility study, the primary outcomes are 1) study inclusion rate, 2) dropout rate, 3) program attendance rate, 4) homework practicing time, and 5) mean and standard deviation after follow-up of the following assessment measures.

Key secondary outcomes

The comparison of the mean values of the FFMQ, UWES, SWLS, FS, SPANE, EQ, PSS, ICECAP-A, and meditation practice time between the study entry and after follow-up. Other evaluation items will include the collection of basic data such as demographics and information from open-ended questionnaires.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Basic workshop for the mindfulness based program

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Must be a physician, nurse, public health nurse, psychiatric social worker, licensed psychologist, or clinical psychologist with at least two years of experience in psychiatric work and whose primary place of employment is a medical institution.
Must be able to participate in both the workshop (2 days face-to-face) and the follow-up (half-day online). Be able to participate in the evaluation (following questionnaire) conducted as part of the validation project.
Must be able to work on ongoing meditation and other assignments (10-15 minutes per day) between the workshop and follow-up.
Must currently be in good physical condition to work a normal workday.
Must be able to obtain a recommendation from a supervisor at work at the time of application
Must be able to give consent to participate in the study

Key exclusion criteria

Those who have previously undergone an 8-week mindfulness based program, such as mindfulness based cognitive therapy or mindfulness based stress reduction, or those who are deemed to have equivalent experience.
Other persons whom the principal investigator determines are not appropriate for inclusion in the study.

Target sample size

30

Name of lead principal investigator

1st name	Mitsuhiro
Middle name
Last name	Sado

Organization

Keio University

Division name

School of Medicine

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

0333531211

Email

mitsusado@keio.jp

Name of contact person

1st name	Mitsuhiro
Middle name
Last name	Sado

Organization

Department of Neuropsychiatry, Keio University School of Medicine

Division name

Department of Neuropsychiatry, Keio University School of Medicine

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

0333531211

Homepage URL

Email

mitsusado@keio.jp

Institute

Keio University

Institute

Department

Personal name

Mitsuhiro Sado

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Keio University School of Medicine

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

Tel

+81-03-3353-1211

Email

med-rinri-jimu@adst.keio.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

11

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

10

Month

31

Day

Date of IRB

2023

Year

10

Month

31

Day

Anticipated trial start date

2023

Year

11

Month

15

Day

Last follow-up date

2023

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

11

Month

14

Day

Last modified on

2023

Year

11

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060255