UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037662 |
|---|---|
| Receipt number | R000042947 |
| Scientific Title | Analysis research of existing questionnaire and medical record data by return to work intervention |
| Date of disclosure of the study information | 2019/08/10 |
| Last modified on | 2022/08/11 14:58:50 |
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Basic information
Public title
Analysis research of existing questionnaire and medical record data by return to work intervention
Acronym
Analysis research of existing questionnaire and medical record data by return to work intervention
Scientific Title
Analysis research of existing questionnaire and medical record data by return to work intervention
Scientific Title:Acronym
Analysis research of existing questionnaire and medical record data by return to work intervention
Region
| Japan |
Condition
Condition
depressive disorder
social anxiety disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study retrospectively examined the outcomes of patients on sick leave who participated in return-to-work interventions for depression at a psychiatric outpatient clinic.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) BDI-2 (Beck Depression Inventory-Second Edition)
2) SASS (Social Adaptation Self-evaluation Scale)
3) LSAS (Liebowitz Social Anxiety Scale)
4) FFMQ (Five Facet Mindfulness Questionnaire)
pre and post intervention
Key secondary outcomes
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
| Behavior,custom |
Interventions/Control_1
return-to-work intervention
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) Enrolled in the return-to-work intervention from April 1, 2008 to September 30, 2017.
2) Consented to the use of personal medical information in the study.
4) Pre-data of BDI-II, SASS, and LSAS (FAS) are available.
Key exclusion criteria
1) Ongoing participation in the return-to-work intervention.2) No consent provided for using personal medical information in the study and chose to opt out of the study.
3) No pre-data of BDI-II, SASS, or LSAS, are available.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Graduate School of Medicine Chiba University
Division name
Department of Cognitive Behavioral Physiology
Zip code
260-8670
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Okamoto |
Organization
Graduate School of Medicine Chiba University
Division name
Department of Cognitive Behavioral Physiology
Zip code
260-8670
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
TEL
043-226-2027
Homepage URL
yoko-okamoto@chiba-u.jp
Sponsor or person
Institute
Graduate School of Medicine Chiba University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare Scientific Research Expenses
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Medicine Chiba University
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
Tel
043-226-2501
igaku-rinri@office.chiba-u.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
| 2019 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
186
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
| 2016 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 10 | Day |
Last modified on
| 2022 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042947
