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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026539
Receipt No. R000030469
Scientific Title Preliminary research toward establishment of cognitive behavioral therapy for depressed patients during hospitalization for the prevention of recurrence by nurses.
Date of disclosure of the study information 2017/03/29
Last modified on 2017/09/08

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Basic information
Public title Preliminary research toward establishment of cognitive behavioral therapy for depressed patients during hospitalization for the prevention of recurrence by nurses.
Acronym Preliminary study toward establishment of cognitive behavioral therapy by nurses.
Scientific Title Preliminary research toward establishment of cognitive behavioral therapy for depressed patients during hospitalization for the prevention of recurrence by nurses.
Scientific Title:Acronym Preliminary study toward establishment of cognitive behavioral therapy by nurses.
Region
Japan

Condition
Condition depression
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to implement a program of cognitive behavior therapy by a nurse.And it is to refine the effect of the program by using the quantitative research method, review the program and refine it.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Patient Health Questionnaire(PHQ-9)
(Program start 0,1,2,3,4,8,16,28 weeks after)
Key secondary outcomes

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 Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 A period:3weeks
Number of program times:4 times(Once a week)
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.A mood disorder patient that diagnosed with DSM-4.
2.A person with 12 points more in BDI-2.
3.After receiving sufficient explanation for participation in this study, patients who gained written consent by the patient's free will with sufficient understanding.
Key exclusion criteria 1.Dementia, Organic mental disease, Alcoholism.
2.Person who has imminent suicide ideation, suicide related behavior.
3.Personality disorder.
4.Doctor does not agree.
5.Research leaders judged that not this study participants.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Komatsu
Organization University of Miyazaki
Division name Center for medical education and career Deveropment
Zip code
Address 5200, kihara, kiyotake, miyazaki, 889-1692 Japan
TEL 0985-85-8305
Email skato@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sayaka Kato
Organization University of Miyazaki
Division name Center for medical education and career Deveropment
Zip code
Address 5200, kihara, kiyotake, miyazaki, 889-1692 Japan
TEL 0985-85-8305
Homepage URL
Email skato@med.miyazaki-u.ac.jp

Sponsor
Institute University of Miyazaki
Institute
Department

Funding Source
Organization Ministry of education
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2017 Year 03 Month 29 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 Preinitiation
Date of protocol fixation
2017 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 29 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
2017 Year 03 Month 14 Day
Last modified on
2017 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030469

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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