UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018762 |
|---|---|
| Receipt number | R000021705 |
| Scientific Title | Effectiveness of a rework manual for patients on sick leave due to mood disorder |
| Date of disclosure of the study information | 2015/08/23 |
| Last modified on | 2020/07/31 16:52:02 |
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Basic information
Public title
Effectiveness of a rework manual for patients on sick leave due to mood disorder
Acronym
Effectiveness of a rework manual for patients on sick leave due to mood disorder
Scientific Title
Effectiveness of a rework manual for patients on sick leave due to mood disorder
Scientific Title:Acronym
Effectiveness of a rework manual for patients on sick leave due to mood disorder
Region
| Japan |
Condition
Condition
Mood Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This trial aims to evaluate the effectivebess of a newly created rework manual designed to facilitate the return to work of patients on sick leave due to mood disorder.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.SASS: Social Adaptation Self-evaluation Scale
2.PRRS: Psychiatric Rework Readiness Scale
After three/six months intervention
Key secondary outcomes
1. HAM-D: Hamilton Rating Scale for Depression
2. BDI: Beck Depression Inventor
3. Duration of sick leave
4. Number of attendance days for one year from the first day of sick leave.
5. Absenteeism after return to work (World Health Organization Heath and Work Performance Questionnaire: WHO-HPQ)
6. Presenteeism after return to work(WHO-HPQ)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
In addition to receiving treatment as usual, patients on sick leave due to mood disorder participate in a return-to-work assistance program administrated by trained clinical psychologists or psychiatrists. Following a rework manual, participants independently complete 20-minute sessions once every two weeks until they return to work.
Interventions/Control_2
Treatment as usual.
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
Key inclusion criteria
1. Patients on sick leave due to mood disorder.
2. Patients with a mean score higher than 1.5 on items 1-9 of the PRRS.
3. Patients with at least six months of sick leave remaining.
4. Patients who have expressed a hope to return to work.
Key exclusion criteria
1. Schizophrenia
2. Substance dependence
3. Organic Psychosis
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Akiyama |
Organization
NTT Medical Center Tokyo
Division name
Department of Neuropsychiatry
Zip code
141-8625
Address
5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo, 141-8625, Japan
TEL
03-3448-6501
akiyama@east.ntt.co.jp
Public contact
Name of contact person
| 1st name | Yoshie |
| Middle name | |
| Last name | Sakai |
Organization
Atomi University
Division name
Department of Clinical Psychology
Zip code
352-8501
Address
1-9-6, Nakano, Niiza-shi, Saitama, 352-8501, Japan
TEL
048-478-3477
Homepage URL
y-sakai@atomi.ac.jp
Sponsor or person
Institute
NTT Medical Center Tokyo
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
University of Occupational and Environmental Health,Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NTT Medical Center
Address
5-9-22, Higashi-Gotanda, Shinagawa-ku, Tokyo
Tel
03-3448-6630
yamaguchi.hirokazu@east.ntt.co.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
NTT東日本関東病院（東京）
産業医科大学（福岡）
NTT Medical Center Tokyo (Tokyo)
University of Occupational and Environmental Health,Japan (Fukuoka)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 23 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 22 | Day |
Last modified on
| 2020 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021705
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| Registered date | File name |
| Research case data | |
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