UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023008
Receipt number R000026522
Scientific Title Effects of a web-based self-care intervention program on improving depressive symptoms and return to work self-efficacy for sick leave employees: a randomized controlled trial
Date of disclosure of the study information 2016/07/07
Last modified on 2017/01/05 13:54:42

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Basic information

Public title

Effects of a web-based self-care intervention program on improving depressive symptoms and return to work self-efficacy for sick leave employees: a randomized controlled trial

Acronym

UTSeL study

Scientific Title

Effects of a web-based self-care intervention program on improving depressive symptoms and return to work self-efficacy for sick leave employees: a randomized controlled trial

Scientific Title:Acronym

UTSeL study

Region

Japan


Condition

Condition

Mild and moderate depression

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to examine the effectiveness of a web-based self-care program on improving depressive symptoms and return to work self-efficacy for sick leave employees with depression compared to those with care as usual. The other purpose of this study is to examine its effectiveness on improving general self-efficacy, changing of locus of control and coping and improving dysfunctional attitude as secondary outcomes.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Severity and symptoms of depression measured by BDI-2 and QIDS-J and return to work self-efficacy (RTW-SE) measured by RTW-SE scale one month after the randomization

Key secondary outcomes

1) General self-efficacy (General self-efficacy scale)
2) Locus of control (Locus of control scale)
3) Coping (Brief Scales for Coping Profile)
4) Dysfunctional attitude (Dysfunctional attitude scale)
5) Life orientation (Life orientation test)
6) Original questions


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 not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

A web-based self learning program which provides process of return to work, case study, skills to maintain life rhythm, psychoeducation of stress management based on cognitive behavioral therapy and one's own career

Interventions/Control_2

Care 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

60 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Age 20-60 at study entry
2) Men and women
3) Sick leave workers with depression
4) can access the internet via a PC, a smart phone or a tablet

Key exclusion criteria

1) Patient with severe depression
2) Patient who quit one's job
3) Patient who has more than two times of sick leave episodes

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akihito Shimazu

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Mental Health

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

+81-3-5841-3612

Email

ashimazu@m.u-tokyo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shunichi Sakan

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Mental Health

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

+81-80-3000-1321

Homepage URL


Email

shunny0614@gmail.com


Sponsor or person

Institute

Ministry of Health, Labour and Welfare

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2016 Year 07 Month 07 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

2016 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 17 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

2016 Year 07 Month 04 Day

Last modified on

2017 Year 01 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026522


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name