UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027864 |
|---|---|
| Receipt number | 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 | 2020/06/25 10:53:36 |
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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 | 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
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
mtajima@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031846
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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