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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018762
Receipt No. 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

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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
Email 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
Email y-sakai@atomi.ac.jp

Sponsor
Institute NTT Medical Center Tokyo
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021705

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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