UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031339 |
|---|---|
| Receipt number | 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 11:04:29 |
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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
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
m-okada@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035636
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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