UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029791 |
|---|---|
| Receipt number | R000034039 |
| Scientific Title | The effect of mindfulness-based stress reduction program for workers |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2018/06/11 11:46:02 |
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Basic information
Public title
The effect of mindfulness-based stress reduction program for workers
Acronym
Mindfulness program for workers
Scientific Title
The effect of mindfulness-based stress reduction program for workers
Scientific Title:Acronym
Mindfulness program for workers
Region
| Japan |
Condition
Condition
Worker
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the effect of mindfulness-based stress reduction program for workers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Depression and anxiety (Baseline and 8 weeks after starting intervention)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Eight weeks mindfulness program (90 min/session)
Interventions/Control_2
8 weeks usual life
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Worker
Key exclusion criteria
serious psychiatric/neurological/internal disease, pregnant women, under any psychotherapy or counseling, and to judge industrial physicians as undesirable for this research
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin Fukudo |
Organization
Tohoku University
Division name
Department of Behavioral Medicine
Zip code
Address
2-1 Seiryo, Aoba-Ku, Sendai
TEL
022-717-8214
sfukudo@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiko Muratsubaki |
Organization
Tohoku University
Division name
Department of Behavioral Medicine
Zip code
Address
2-1 Seiryo, Aoba-Ku, Sendai
TEL
022-717-8162
Homepage URL
t-mura@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Corporation
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
Address
Tel
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
| 2017 | Year | 11 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 01 | Day |
Last modified on
| 2018 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034039
