UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018123
Receipt number R000020986
Scientific Title Effectiveness of cognitive behavioral group therapy for depressive disorders using physiological and psychological indicators
Date of disclosure of the study information 2015/06/29
Last modified on 2021/01/04 16:50:29

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Basic information

Public title

Effectiveness of cognitive behavioral group therapy for depressive disorders using physiological and psychological indicators

Acronym

Effectiveness of cognitive behavioral group therapy for depressive disorders

Scientific Title

Effectiveness of cognitive behavioral group therapy for depressive disorders using physiological and psychological indicators

Scientific Title:Acronym

Effectiveness of cognitive behavioral group therapy for depressive disorders

Region

Japan


Condition

Condition

Depressive Disorder

Classification by specialty

Psychiatry Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effectiveness of nurse-led cognitive behavioral group therapy for depressive disorders using physiological and psychological indicators.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Beck Depression Inventory (BDI-II)

Key secondary outcomes

Quick Inventory of Depressive Symptomatology (QIDS-J)
MOS Short-Form 36-item Health Survey Version2 (SF-36V2)
Self-Esteem Scale
Near Infra-Red Spectroscopy


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 group 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

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

Depressive disorder (DSM-IV)
Total BDI-II scores at 10 or above

Key exclusion criteria

Organic brain disorder, alcohol Dependence/abuse, dementia
Active suicidality
Personality disorder

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Yuko
Middle name
Last name Shiraishi

Organization

International University of Health and Welfare

Division name

Faculty of Nursing

Zip code

814-0001

Address

Momotihama1-7-4,Sawara ward, Fukuoka-city,Fukuoka Prefecture

TEL

092-407-1543

Email

s-yuko@iuhw.ac.jp


Public contact

Name of contact person

1st name Yuko
Middle name
Last name Shiraishi

Organization

International University of Health and Welfare

Division name

Faculty of Nursing

Zip code

814-0001

Address

Momotihama1-7-4,Sawara ward, Fukuoka-city,Fukuoka Prefecture

TEL

092-407-1543

Homepage URL


Email

s-yuko@iuhw.ac.jp


Sponsor or person

Institute

International University of Health and Welfare

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology (MEXT)

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

University of Miyazaki Hospital
Wakakusa Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

International University of Health and Welfare,Faculty of Nursing

Address

Momotihama1-7-4,Sawara ward, Fukuoka-city,Fukuoka Prefecture

Tel

092-407-1543

Email

s-yuko@iuhw.ac.jp


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

宮崎大学医学部附属病院精神科
University of Miyazaki Hospital
宮崎大学医学部附属病院精神科
Wakakusa Hospital
医療法人如月会若草病院
University of Miyazaki Hospital


Other administrative information

Date of disclosure of the study information

2015 Year 06 Month 29 Day


Related information

URL releasing protocol

http://www.elsevier.com/journals/international-journal-of-nursing-sciences/2352-0132

Publication of results

Partially published


Result

URL related to results and publications

http://www.elsevier.com/journals/international-journal-of-nursing-sciences/2352-0132

Number of participants that the trial has enrolled

23

Results

Of25 participante screened,23 were eligible for the study(of these,three dropped out during the trial but were includes in the analysis).Nurse-led group CBT led to significant improvements in the severity of primary and secondary depression(p<0.001).The mean total BDI score improved 23.1(SD=7.56 )to 12.4(SD=8.57),and the pre-to post-effect size was large(Cohen's d=1.33).After CBT,45% of the participants were judged to be treatment responders,and 34% met the criteria for remission.

Results date posted

2020 Year 07 Month 02 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2018 Year 12 Month 15 Day

Baseline Characteristics

Participants were recruited at one hospital and one general hospital in Miyazaki Prefecture,Japan.The criteria for study inclusion were:a primary diagnosis of majoor depressive disorder(DSM-4).BDI-2score>10.
aged 18-65years.

Participant flow

The participants were recruited to gain the permission of their primary psyvhiatrist to participate in the study,and written informed consent was obtained from all participants after the study procedures had been fully explained.

Adverse events

none

Outcome measures

BDI-2:Beck Depression Inventory
QIDS-SR:Quick Inventiry of Depressive Symptomatology-Self Rated
RSES:Rosenberg Self-Esteem Scale

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 10 Month 01 Day

Date of IRB

2012 Year 11 Month 19 Day

Anticipated trial start date

2014 Year 05 Month 01 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry

2016 Year 04 Month 30 Day

Date trial data considered complete

2016 Year 05 Month 15 Day

Date analysis concluded

2016 Year 05 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 06 Month 29 Day

Last modified on

2021 Year 01 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020986


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name