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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017215
Receipt No. R000019967
Scientific Title An examination of the mechanism of cognitive behavioral therapy for depression
Date of disclosure of the study information 2015/04/21
Last modified on 2018/04/28

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Basic information
Public title An examination of the mechanism of cognitive behavioral therapy for depression
Acronym An examination of the mechanism of cognitive behavioral therapy for depression
Scientific Title An examination of the mechanism of cognitive behavioral therapy for depression
Scientific Title:Acronym An examination of the mechanism of cognitive behavioral therapy for depression
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to whether behavioral activation could demonstrate significant decrease in depressive symptoms. Also, this study is to examine significant change of brain function from pre-treatment to post-treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Beck Depression Inventory-II
Key secondary outcomes Behavioral Activation for Depression Scale, Environmental Reward Observation Scale,
Euro QolEQ-5-D,Generalized Self-Efficacy Scale, fMRI.

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 Behavioral activation
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

Not applicable
Gender Male and Female
Key inclusion criteria (1)Participants who met Diagnostic and statistical manual of mental disorders (DSM) criteria for major depressive episode in DSM
(2)Outpatients who were judged by the psychiatrist to be in need of psychological intervention
(3)Participants who got informed consent
Key exclusion criteria (1)Participants who can not understand purpose of the study for serious mental state
(2)Participants who can not endure investigation for serious physical disease
(3)Participants who met Diagnostic and statistical manual of mental disorders (DSM) criteria for bipolar disorder
(4)Participants who can not carry out MRI examination
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasumasa Okamoto
Organization Hiroshima university institute of biomedical and health sciences
Division name Department of Psychiatry and Neurosciences
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5208
Email oy@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koki Takagaki
Organization Hiroshima university institute of biomedical and health sciences
Division name Department of Psychiatry and Neurosciences
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5208
Homepage URL
Email koki.takagaki@gmail.com

Sponsor
Institute Department of Psychiatry and Neurosciences, Hiroshima University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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
2015 Year 04 Month 21 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 Terminated
Date of protocol fixation
2014 Year 09 Month 02 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 22 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
2015 Year 04 Month 21 Day
Last modified on
2018 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019967

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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