UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026539
Receipt number 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 2020/01/29 09:20:10

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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 or person

Institute

University of Miyazaki

Institute

Department

Personal name



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

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

15

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

Main results already published

Date of protocol fixation

2017 Year 03 Month 22 Day

Date of IRB

2017 Year 01 Month 10 Day

Anticipated trial start date

2017 Year 03 Month 29 Day

Last follow-up date

2020 Year 03 Month 31 Day

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

2020 Year 01 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030469


Research Plan
Registered date File name
2021/02/01 研究実施計画書 2020.02.18変更.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name