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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031339
Receipt No. R000035636
Scientific Title The effectiveness of the group psychology education program combining individual support for patients with bipolar disorder
Date of disclosure of the study information 2018/02/19
Last modified on 2019/02/27

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Basic information
Public title The effectiveness of the group psychology education program combining individual support for patients with bipolar disorder
Acronym The study of group psychology education program for bipolar disorder patients
Scientific Title The effectiveness of the group psychology education program combining individual support for patients with bipolar disorder
Scientific Title:Acronym 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
1st name
Middle name
Last name Takashi Tsuboi
Organization Kyorin University
Division name Department of Neuropsychiatry
Zip code
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
1st name
Middle name
Last name Masaya Okada
Organization Kyorin University
Division name Department of Psychiatric Nursing
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Enrolling by invitation
Date of protocol fixation
2018 Year 01 Month 26 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000035636

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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