UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of short-term self stigma reduction program for depression
Title of the study (Brief title)	Feasibility study of short-term self stigma reduction program for depression
Region	Japan

Condition
Condition	Depressive Disorders(Major Depressive Disorder)
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we aim to collect information that is useful for developing the short-term self-stigma reduction program. We interview outpatients, who are diagnosed with depressive disorders, to obtain information about perceived stigmatization. We also evaluate effectiveness of making a coping plan with stigmatization through cognitive behavioral technique.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Outcomes will be measured using the Japanese versions of the Devaluation-Discrimination Scale (DDS), Depression Self Stigma Scale (DSSS), and Rosenberg's Self Esteem Scale.
Key secondary outcomes	Subjective depression (measured with the BDI-2) and objective depression (measured with HAMD-17) score at post will be compared from the baseline.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Psychoeducational intervention for depression Cognitive-behavioral intervention
Interventions/Control_2
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1.Outpatients with depressive symptoms diagnosed with Depressive Disorders (DSM-5) or Major Depressive Disorder (DSM-4). 2.Subjects who give full consent in the participation of the study.
Key exclusion criteria	No past treatment of GCBT or counseling.
Target sample size	20

Research contact person
Name of lead principal investigator	Sakie Shimotsu
Organization	Kobe Yamate University
Division name	Faculty for the study of Contemporary Society
Address	6-5-2, Nakayamatedori, Chuo-ku, Kobe City, 650-0004
TEL	078-371-8000
Email	ishimots@gmail.com

Public contact
Name of contact person	Sakie Shimotsu
Organization	Kobe Yamate University
Division name	Faculty for the study of Contemporary Society
Address	6-5-2, Nakayamatedori, Chuo-ku, Kobe City, 650-0004
TEL	078-371-8000
Homepage URL
Email	ishimots@gmail.com

Sponsor
Institute	Kobe Yamate University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
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	埼玉医科大学総合医療センター（埼玉県）、細見クリニック（宮崎県）

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 01 Day
Anticipated trial start date	2014 Year 12 Month 10 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
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	2014 Year 10 Month 24 Day
Last modified on	2016 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018003