UMIN-CTR Clinical Trial

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

major depressive disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

NTT Medical Center Tokyo

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

NTT東日本関東病院（東京都）

Date of disclosure of the study information

2013

Year

02

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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