UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Akihito Shimazu
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Mental Health
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	Shunichi Sakan
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Mental Health
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL	+81-80-3000-1321
Homepage URL
Email	shunny0614@gmail.com

Sponsor
Institute	Ministry of Health, Labour and Welfare
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026522