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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023320
Receipt No. R000026847
Scientific Title Effectiveness Study of Cognitive Behavioral Therapy for Major Depressive Disorder - A single-arm pilot study
Date of disclosure of the study information 2016/08/07
Last modified on 2016/07/25

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Basic information
Public title Effectiveness Study of Cognitive Behavioral Therapy for Major Depressive Disorder - A single-arm pilot study
Acronym Cognitive Behavioral Therapy for Major Depressive Disorder - pilot study
Scientific Title Effectiveness Study of Cognitive Behavioral Therapy for Major Depressive Disorder - A single-arm pilot study
Scientific Title:Acronym 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)

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

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
1st name
Middle name
Last name Eiji Shimizu
Organization Graduate School of Medicine Chiba University
Division name Research Center for Child Mental Development, Department of Cognitive Behavioral Physiology
Zip code
Address 1-8-1 Inohana, Chuouku, Chiba, Japan
TEL 043-226-2027
Email eiji@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoichi Hiramatsu
Organization Graduate School of Medicine Chiba University
Division name Research Center for Child Mental Development
Zip code
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

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)

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 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

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
2013 Year 09 Month 30 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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