UMIN-CTR Clinical Trial

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
Institute	International University of Health and Welfare
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020986