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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
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 | 2020/06/25 |
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 |
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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 |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |