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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028052
Receipt No. R000031379
Scientific Title Development of a psychoeducation program for bipolar disorder
Date of disclosure of the study information 2017/07/24
Last modified on 2019/07/05

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Basic information
Public title Development of a psychoeducation program for bipolar disorder
Acronym Development of a psychoeducation program for bipolar disorder
Scientific Title Development of a psychoeducation program for bipolar disorder
Scientific Title:Acronym Development of a psychoeducation program for bipolar disorder
Region
Japan

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

Objectives
Narrative objectives1 to examine efficacy of the psychoeducation program in preventing recurrences
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes number of times of recurrences for 24 months before the program participation and 24 months after participation
Key secondary outcomes

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 psychoeducation program, one session 100-120 minutes, biweekly, total 8 sessions
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)diagnosed as bipolar disorder aged over 20 years
2)spend at least for 2 years in medical treatment
3)have permission to participate in the program from their doctor
4)have willingness and ability to give written informed consent to participate in the study
Key exclusion criteria 1)have self-harm or other harm at the time of participation
2)found to have interectual disability or neurocognitive disfunction
3)with serious physical complications
4)judged by the attending physician that ability to consent is impaired
5)judged unsuitable as the subject by the research director
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Katsuji
Middle name
Last name Nishimura
Organization Tokyo Women's Medical University
Division name Department of Psychiatry
Zip code 162-8666
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-8111
Email nishimura.katsuji@twmu.ac.jp

Public contact
Name of contact person
1st name Atsuko
Middle name
Last name Inoue
Organization Tokyo Women's Medical University
Division name Department of Psychiatry
Zip code 162-8666
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-8111
Homepage URL
Email inoue.atsuko@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Japan Society for the promotion of Science (JSPS), Grant-in-Aid for Scientific Research (KAKENHI)
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 Tokyo Women's Medical University
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
Tel 03-3353-8111
Email rinri.bm@twmu.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 東京女子医科大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 24 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
2014 Year 11 Month 11 Day
Date of IRB
2014 Year 11 Month 11 Day
Anticipated trial start date
2014 Year 12 Month 19 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 03 Day
Last modified on
2019 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031379

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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