UMIN-CTR Clinical Trial

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
Email	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
Email	yoko-okamoto@chiba-u.jp

Sponsor
Institute	Graduate School of Medicine Chiba University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042947