UMIN-CTR Clinical Trial

Basic information
Public title	The elucidation of the stress mechanism of employees on sick leave due to depression, and the effect of the return-to-work program using cognitive behavior therapy
Acronym	Return-to-work program using Cognitive Behavior Group Therapy for employees on sick leave due to depression
Scientific Title	The elucidation of the stress mechanism of employees on sick leave due to depression, and the effect of the return-to-work program using cognitive behavior therapy
Scientific Title:Acronym	Return-to-work program using Cognitive Behavior Group Therapy for employees on sick leave due to depression
Region	Japan

Condition
Condition	Depression
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify that stress of employees on sick leave due to depression using psychological and biological parameters. We also examine to the efficacy of the cognitive behavior group therapy for the return-to-work of employees on sick leave due to depression using psychological and biological parameters.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Cortisol, CRP
Key secondary outcomes	Montgomery Asberg Depression Rating Scale(MADRS) Patient Health Questionnaire (PHQ-9) Clinical Global Impression(CGI) Behavior Activation for Depression Scale Environmental Reward Observation Scale Dysfunctional Attitude Scale 24(DAS24) Difficulties in Returning to Work Inventory (DRW)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are 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	Coginive behavior group therapy, once a week , 10weeks (about 3 months)
Interventions/Control_2	Treatment as usual(TAU)
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	(a) 20-65 years old male or female, (b) a diagnosis of major depressive disorder for the current or past episode established by a psychiatrist or a clinical psychologist using the Structured Clinical Interview for DSM-4(SCID), (c)Informed consent is obtained, (d)When the persons are under going to other hospital expect Omiya Suzunoki clinic, only them can participate in cognitive behavior group therapy who brings a letter of introduction after permission of participant the treatment by their attending physicians.
Key exclusion criteria	current or previous diagnosis of a psychotic spectrum disorder, evidence of organic brain disorder, mental retardation, personality disorder, current high risk of suicide, substance abuse, or serious somatic disease.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Miki Middle name Last name Matsunaga
Organization	Rikkyo University
Division name	Department of Psychology
Zip code	3528558
Address	1-2-26 Kitano, Niiza-shi, Saitama 352-8558, Japan
TEL	048-471-7069
Email	mikim@rikkyo.ac.jp

Public contact
Name of contact person	1st name Miki Middle name Last name Matsunaga
Organization	Rikkyo University
Division name	Department of Psychology
Zip code	3528558
Address	1-2-26 Kitano, Niiza-shi, Saitama 352-8558, Japan
TEL	048-471-6901
Homepage URL
Email	mikim@rikkyo.ac.jp

Sponsor
Institute	Rikkyo University
Institute
Department

Funding Source
Organization	MEXT
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Rikkyo University
Address	3-34-1, NishiIkebukuro, Toshima, Tokyo
Tel	03-3985-4589
Email	lifescience@rikkyo.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	大宮すずのきクリニック（埼玉県）

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 04 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 05 Month 24 Day
Date of IRB	2018 Year 09 Month 25 Day
Anticipated trial start date	2018 Year 10 Month 04 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 06 Month 30 Day
Date trial data considered complete
Date analysis concluded	2022 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2018 Year 10 Month 04 Day
Last modified on	2022 Year 04 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039181