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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010073
Receipt No. R000011795
Scientific Title Effectiveness of a return-to-work assist program for patients on sick leave due to major depressive disorder: a multi-institutional randomized controlled trial
Date of disclosure of the study information 2013/02/19
Last modified on 2020/07/31

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Basic information
Public title Effectiveness of a return-to-work assist program for patients on sick leave due to major depressive disorder: a multi-institutional randomized controlled trial
Acronym Effectiveness of a return-to-work assist program for major depressive disorder: a randomized controlled trial
Scientific Title Effectiveness of a return-to-work assist program for patients on sick leave due to major depressive disorder: a multi-institutional randomized controlled trial
Scientific Title:Acronym Effectiveness of a return-to-work assist program for major depressive disorder: a randomized controlled trial
Region
Japan

Condition
Condition major depressive disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of a return-to-work assist program for patients on sick leave due to major depressive disorder.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes 1. Social Adaptation Self-evaluation Scale(SASS)
2. Psychiatric Rework Readiness Scale (PRRS)
3. Hamilton Rating Scale for Depression 17 items (HRSD-17)
4. Beck Depression Inventory-Second Edition (BDI-II)
5. Dysfunctional Attitudes Scale (DAS-24)

All outcomes are assessed by blinded assessor (clinical psychologist) before intervention and 24 weeks later from beginning of intervention.
Key secondary outcomes 1. Relapse
2. Return to work
3. Cognitive function

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification NO
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 A group rehabilitation program, including office work, group psychotherapy, psychoeducation, and sports programs conducted by therapists, held 2 to 5 times per week for 6 months.
Interventions/Control_2 Treatment as usual and individual guidance by an experienced psychiatrist for 15 minutes, twice a month, for 6 months.
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
55 years-old >=
Gender Male and Female
Key inclusion criteria 1. Age 20 to 55 years at screening.
2. Subjects with current DSM-IV major depressive disorder.
3. Patients on sick leave due to major depressive disorder.
4. HAMD-17 <= 15 at screening.
5. Duration of sick leave due to depression of 1 months to 2 years, comprising taking sick leave due to depression up to three times.
Key exclusion criteria 1. Bipolar I disorder
2. Alcohol dependency, alcohol abuse
3. Organic brain disorder
4. Schizophrenia
5. Borderline personality disorder
Target sample size 120

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 03-3448-6508
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@sb3.so-net.ne.jp

Sponsor
Institute NTT Medical Center Tokyo
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 19 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 Completed
Date of protocol fixation
2011 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 12 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
2013 Year 02 Month 19 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=R000011795

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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