UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Group Cognitive Behavioural Therapy with Compassion Training on Depression
Title of the study (Brief title)	Effect of Group Cognitive Behavioural Therapy with Compassion Training on Depression
Region	Japan

Condition
Condition	Major Depression
Classification by specialty	Psychosomatic Internal Medicine Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To report the preliminary outcomes and feasibility of group CFT program for major depression in Japanese clinical settings.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	BDI-II
Key secondary outcomes	Self-compassion

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	Cognitive behavioural therapy with compassion works
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	18 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	The criteria for inclusion in this study were a primary diagnosis of major depression according to the DSM-IV.
Key exclusion criteria	The exclusion criteria were psychosis, pervasive developmental disorders/mental retardation, autism spectrum disorders, current high risk of suicide, substance abuse or dependence in the past 6 months, antisocial personality disorder, unstable medical condition, pregnancy, or lactation.
Target sample size	15

Research contact person
Name of lead principal investigator	Kenichi Asano
Organization	Graduate School of Medicine, Chiba University
Division name	Research Center for Child Mental Development
Address	1-8-1, inohana, Chuo-ku, Chiba city
TEL	043-226-2975
Email	kenichi.asano@chiba-u.jp

Public contact
Name of contact person	Kenichi Asano
Organization	Graduate School of Medicine, Chiba University
Division name	Research Center for Child Mental Development
Address	1-8-1, inohana, Chuo-ku, Chiba city
TEL	043-226-2975
Homepage URL
Email	kenichi.asano@chiba-u.jp

Sponsor
Institute	Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization	MEXT
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 09 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 01 Day
Anticipated trial start date	2014 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 08 Month 31 Day
Last modified on	2017 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016862