UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056527 |
|---|---|
| Receipt number | R000064596 |
| Scientific Title | Investigation of the effectiveness of Overcoming Self-Stigma in Bipolar Disorder and the elucidation of its neural mechanisms |
| Date of disclosure of the study information | 2024/12/23 |
| Last modified on | 2025/03/28 11:24:40 |
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Basic information
Public title
A study on the effectiveness of Overcoming Self-Stigma in Bipolar Disorder and its neural mechanisms
Acronym
Self-Stigma reduction and brain functioning in bipolar disorder
Scientific Title
Investigation of the effectiveness of Overcoming Self-Stigma in Bipolar Disorder and the elucidation of its neural mechanisms
Scientific Title:Acronym
Self-Stigma reduction and brain function research in bipolar disorder
Region
| Japan |
Condition
Condition
Bipolar Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to implement a self-stigma reduction program for patients with bipolar disorder, evaluate its effectiveness, and investigate changes in brain function after the program using neuroimaging to elucidate the brain mechanism of self-stigma.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to implement a self-stigma reduction program for patients with bipolar disorder, evaluate its effectiveness, and investigate changes in brain function after the program using neuroimaging to elucidate the brain mechanism of self-stigma.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Check for reduction by changes in Self-Stigma Rating Scale score.
Key secondary outcomes
To examine the relationship between changes in psychiatric symptoms and self-stigma and NIRS data and MRI imaging data.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
To examine NIRS, MRI, and clinical assessments in the baseline visit, and 8 to 16 weeks later, to examine NIRS, MRI, and clinical evaluation.
Interventions/Control_2
To examine NIRS, MRI, and clinical assessments in the baseline visit. Self-stigma reduction programs(total of eight sessions) will be conducted at a maximum of two week intervals. NIRS, MRI, and clinical evaluation will be performed at the end of the program.
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
| 18 | years-old | < |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
bipolar disorder based on DSM.
Key exclusion criteria
A subject with brain organic disorders, low IQ (<70), brain injury, unstable medical condition, the first-degree relatives of neurological disorders, personality disorders, or substance use disorders.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Kamimura |
Organization
Saitama Medical University Hospital
Division name
Psychiatry
Zip code
3500495
Address
38 Morohongo, Moroyama, Iruma, Saitama, Japan
TEL
0492761214
hisa_k@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Kamimura |
Organization
Saitama Medical University Hospital
Division name
Psychiatry
Zip code
3500495
Address
38 Morohongo, Moroyama, Iruma, Saitama, Japan
TEL
0492761214
Homepage URL
hisa_k@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University Hospital
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
Institutional Review Board of Saitama Medical University Hospital
Address
38 Morohongo, Moroyama, Iruma, Saitama, Japan
Tel
0492761111
hirb@saitama-med.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2024 | Year | 12 | Month | 20 | Day |
Last modified on
| 2025 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064596
