UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010073 |
|---|---|
| Receipt number | 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 17:07:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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@sb3.so-net.ne.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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011795
