UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028052 |
|---|---|
| Receipt number | R000031379 |
| Scientific Title | Development of a psychoeducation program for bipolar disorder |
| Date of disclosure of the study information | 2017/07/24 |
| Last modified on | 2023/07/18 17:14:58 |
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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
Percentage of hospitalized patients(2 years prior to/ after participation)
self-efficacy(pre, post, after 1 year, after 2 years)
QOL(pre, post, after 1 year, after 2 years)
treatment satisfaction(post)
Illness Perception(pre, post, after 1 year, after 2 years)
symptom severity(pre, post, once every 2 months after completion up to 2 years)
participant's feeling (during participation, after 1 year, after 2 years)
social life situation (pre, post, after 1 year, after 2 years)
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
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
inoue.atsuko@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
Japan
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
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
Not open to the public
Publication of results
Unpublished
Result
URL related to results and publications
Not open to the public
Number of participants that the trial has enrolled
55
Results
The number of hospitalizations of the 47 completed participants decreased significantly before and after psychoeducation. Self-efficacy improved significantly after participation than before.
Results date posted
| 2023 | Year | 07 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 47 participants analyzed, 17 were male and 30 were female. All participants were Japanese, and 15 were diagnosed with bipolar I disorder and 32 with bipolar II disorder.
Participant flow
A total of 76 people applied for the program, and 55 who met the criteria participated in the psychoeducation program, excluding those who withdrew their participation request before the start of the psychoeducation. During the course of the program, five participants stopped participating, four due to deterioration of their condition and one due to unknown reasons. Another withdrew to participate in a rework program. Finally, 49 participants completed the program (completion rate: 89.1%).
During the follow-up period after completion of the program, two participants withdrew their consent to the study; therefore, 47 participants (85.4%) who completed the program and follow-up were included in the analysis in this study.
Adverse events
None
Outcome measures
Number of psychiatric admissions(recurrences)due to bipolar disorder
Percentage of hospitalizations
Young Mania Rating Scale(YMRS)
The 17 item Hamilton Depression Rating Scale(HAM-D17)
Client Satisfaction Questionnaire Japanese version(CSQ-8J)
Self-efficacy
Social life situation
Impressions of participants
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
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
| 2023 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031379
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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