UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness Study of Cognitive Behavioral Therapy for Major Depressive Disorder - A single-arm pilot study
Title of the study (Brief title)	Cognitive Behavioral Therapy for Major Depressive Disorder - pilot study
Region	Japan

Condition
Condition	Major Depressive Disorder
Classification by specialty	Psychiatry Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine effectiveness and feasibility of cognitive behavioral therapy for major depressive disorder in Japanese clinical settings
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	BDI-2(Beck Depression Inventory-Second Edition)
Key secondary outcomes	EQ-5D(EuroQol5-Dimension) PHQ-9(Patient Health Questionnaire) GAD-7(Generalized Anxiety Disorder) MDS(Mental Defeat Scale) CFS(Cognitive Flexibility Scale) SUIS(Spontaneous Use of Imagery Scale)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Maneuver
Interventions/Control_1	Cognitive Behavioral Therapy
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	Primary diagnosis of major depressive disorder
Key exclusion criteria	psychotic disorder active suicidality organic brain disorder antisocial personality disorder other severe mental / physical condition
Target sample size	20

Research contact person
Name of lead principal investigator	Eiji Shimizu
Organization	Graduate School of Medicine Chiba University
Division name	Research Center for Child Mental Development, Department of Cognitive Behavioral Physiology
Address	1-8-1 Inohana, Chuouku, Chiba, Japan
TEL	043-226-2027
Email	eiji@faculty.chiba-u.jp

Public contact
Name of contact person	Yoichi Hiramatsu
Organization	Graduate School of Medicine Chiba University
Division name	Research Center for Child Mental Development
Address	1-8-1 Inohana, Chuouku, Chiba, Japan
TEL	043-226-2027
Homepage URL
Email	flatpine@chiba-u.jp

Sponsor
Institute	Department of Cognitive Behavioral Physiology Graduate School of Medicine, Chiba University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	The Japanese Ministry of Health, Labour and Welfare Department of Cognitive Behavioral Physiology Graduate School of Medicine, Chiba University
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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	千葉大学医学部附属病院、千葉大学医学研究院（千葉県）　Chiba university hospital, Graduate School of Medicine Chiba University (Chiba)

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 30 Day
Anticipated trial start date	2014 Year 04 Month 02 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 25 Day
Last modified on	2016 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026847