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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027864
Receipt No. R000031846
Scientific Title Effectiveness of modified Re-work program: Work focused CBT and workplace consultation
Date of disclosure of the study information 2017/07/01
Last modified on 2017/06/22

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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
Middle name
Last name Miyuki Tajima
Organization National Center of Neurology and Psychiatry
Division name National Center for Cognitive Behavior Therapy and Research
Zip code
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
Middle name
Last name Miyuki Tajima
Organization National Center of Neurology and Psychiatry
Division name National Center for Cognitive Behavior Therapy and Research
Zip code
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
Address
Tel
Email

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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
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
2017 Year 06 Month 22 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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