UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029885 |
|---|---|
| Receipt number | R000034132 |
| Scientific Title | Mindfulness Training in Return-to-Work Program |
| Date of disclosure of the study information | 2017/11/08 |
| Last modified on | 2019/08/16 14:40:38 |
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Basic information
Public title
Mindfulness Training in Return-to-Work Program
Acronym
Mindfulness Training in Return-to-Work Program
Scientific Title
Mindfulness Training in Return-to-Work Program
Scientific Title:Acronym
Mindfulness Training in Return-to-Work Program
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to study the effectiveness of mindfulness training in return-to-work
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
GHQ,Work-Life-Blance
Key secondary outcomes
self-compassion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
| Other |
Interventions/Control_1
Mindfulness Training
Interventions/Control_2
Non-intervention
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
to get informed consent
Key exclusion criteria
nothing
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Nakagawa |
Organization
Kobe Gakuin Univ.
Division name
department of Psychology
Zip code
651-2180
Address
518 Arise,Ikawadani-cho,Nishi-ku,Kobe
TEL
078-974-1551
h-nakagawa@psy.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Nakagawa |
Organization
Kobe Gakuin Univ.
Division name
department of Psychology
Zip code
651-2180
Address
518 Arise,Ikawadani-cho,Nishi-ku,Kobe
TEL
078-974-1551
Homepage URL
h-nakagawa@human.kobegakuin.ac.jp
Sponsor or person
Institute
Kobe Gakuin Univ.
Institute
Department
Personal name
Funding Source
Organization
Kobe Gakuin Univ.
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
Kobe Gakuin Univ.
Address
518 Arise,Ikawadani-cho,Nishi-ku,Kobe
Tel
078-974-1551
kenkyu@j.kobegakuin.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
| 2017 | Year | 11 | Month | 08 | 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
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
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 | 08 | Day |
Last modified on
| 2019 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034132
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
