UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000011795