UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effectiveness of the group psychology education program combining individual support for patients with bipolar disorder
Title of the study (Brief title)	The study of group psychology education program for bipolar disorder patients
Region	Japan

Condition
Condition	bipolar disorder
Classification by specialty	Psychiatry Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify relapse prevention effect of the group psychology education
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To compare the rate of relapse and rehospitalization for 6 months before including the program with that for 12 months after the program ends.
Key secondary outcomes	To evaluate MADRS, YMRS, GAF, SAI-J, BEMIB at the baseline and the end of the program. To evaluate CGI-BP, the treatment satisfaction at the every visit.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	To participate in the group psychology education program.
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	1) Outpatient from 20 to 65 years old 2) DSM-5 diagnosis of bipolar disorder 3) Having been stable (CGI-BP is less than 3 for the past 6 months) and been permitted to participate in the program 4) With no serious physical complications 5) Being capable of providing informed consent
Key exclusion criteria	1) With serious brain organic disease such as cerebral infarction, drug-related disorder, or dementia 2) In the remarkable manic state or the depressed state
Target sample size	40

Research contact person
Name of lead principal investigator	Takashi Tsuboi
Organization	Kyorin University
Division name	Department of Neuropsychiatry
Address	6-20-2 Shinkawa, Mitaka-shi, Tokyo 181-8611 Japan
TEL	0422-47-5511
Email	takashi.tsuboi.0821@gmail.com

Public contact
Name of contact person	Masaya Okada
Organization	Kyorin University
Division name	Department of Psychiatric Nursing
Address	6-20-2 Shinkawa, Mitaka-shi, Tokyo 181-8611 Japan
TEL	0422-47-5511
Homepage URL
Email	m-okada@ks.kyorin-u.ac.jp

Sponsor
Institute	Kyorin University
Institute
Department

Funding Source
Organization	Japan Society for the promotion of Science(JSPS)
Organization
Division
Category of Funding Organization	Other
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	杏林大学医学部付属病院（東京都）/Kyorin University Hospital(Tokyo)

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 19 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 01 Month 26 Day
Anticipated trial start date	2018 Year 03 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	2018 Year 02 Month 16 Day
Last modified on	2019 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035636