UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of modified Re-work program: Work focused CBT and workplace consultation
Acronym	Effectiveness of modified Re-work program: Work focused CBT and workplace consultation
Scientific Title	Effectiveness of modified Re-work program: Work focused CBT and workplace consultation
Scientific Title:Acronym	Effectiveness of modified Re-work program: Work focused CBT and workplace consultation
Region	Japan

Condition
Condition	Major Depressive Disorder, Persistent Depressive Disorder, Unspecified Depressive Disorder, Specific Phobia, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Generalized Anxiety Disorder, Unspecified Anxiety Disorder, and Adjustment Disorders(DSM-5)
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of the Rework program by before-after study, which is targeting workers on leave primarily diagnosed with Depressive Disorders, Anxiety Disorders, or Adjustment Disorders and intervening in them with work-focused CBT and workplace consultation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Return-to-work rate after end of the intervention (19 weeks)
Key secondary outcomes	Effectiveness Evaluation 1. number of days from program start to returning to workplace 2. number of days from program start to an official announcement of an appointment to the post 3. number of days from program start to full reinstatement 4. Working duration after returning to work 5. Psychological variable (Psychiatric Rework Readiness Scale, Patient Health Questionnaire-9, Beck Depression Inventory-II, Generalized Anxiety Disorder-7, Dysfunctional Attitude Scale-24, Cognitive Flexibility Inventory, King's Stigma Scale short version, Behavioral Activation for Depression Scale Short Form(BADS-SF), Kikuchi's Scale of Social Skills-18) 6. number of days of leave of absence Feasibility Evaluation 1. Drop out rate 2. Program completion rate 3. Attendance rate 4. Adverse event rate

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	Maneuver
Interventions/Control_1	Rework program: Basic program (Work-focused CBT, Job training, Physical exercise), coordinating meetings for workplace consultation, individual counseling (once a week)
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. Workers on leave and primarily diagnosed with Major Depressive Disorder, Persistent Depressive Disorder, Unspecified Depressive Disorder, Specific Phobia, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Generalized Anxiety Disorder, Unspecified Anxiety Disorder, and Adjustment Disorders in DSM-5 criteria 2. Those who have clear will to return to work 3. Those who have a permission from attending physician and workplace to participate in the Rework program and the research 4. Those who could attend the program 2 days or more out of 3 days during a week trial 5. Those who aged from 20 to 64 inclusive, at the point of entry
Key exclusion criteria	1. Patients diagnosed with Schizophrenia, Bipolar and Related Disorders, or Personality Disorders 2. Patients deemed inappropriate for the participation by other reasons
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Miyuki Middle name Last name Tajima
Organization	National Center of Neurology and Psychiatry
Division name	National Center for Cognitive Behavior Therapy and Research
Zip code	1878551
Address	4-1-1 Ogawa-Higashi, Kodaira,Tokyo 187-8551, Japan
TEL	042-341-2712
Email	mtajima@ncnp.go.jp

Public contact
Name of contact person	1st name Miyuki Middle name Last name Tajima
Organization	National Center of Neurology and Psychiatry
Division name	National Center for Cognitive Behavior Therapy and Research
Zip code	1878551
Address	4-1-1 Ogawa-Higashi, Kodaira,Tokyo 187-8551, Japan
TEL	042-341-2712
Homepage URL
Email	mtajima@ncnp.go.jp

Sponsor
Institute	National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization	National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)	Pfizer Health Research Foundation

IRB Contact (For public release)
Organization	National Center of Neurology and Psychiatry
Address	4-1-1 Ogawa-Higashi, Kodaira,Tokyo 187-8551, Japan
Tel	042-341-2712
Email	mtajima@ncnp.go.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 07 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	20
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	2017 Year 03 Month 31 Day
Date of IRB	2016 Year 12 Month 21 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2020 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 06 Month 22 Day
Last modified on	2020 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031846

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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