UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045365 |
|---|---|
| Receipt number | R000051802 |
| Scientific Title | Examination of enhancing the effect of cognitive behavioral therapy for patients with fibromyalgia |
| Date of disclosure of the study information | 2021/09/03 |
| Last modified on | 2021/09/03 11:41:33 |
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Basic information
Public title
Examination of enhancing the effect of cognitive behavioral therapy for patients with fibromyalgia
Acronym
Examination of enhancing the effect of cognitive behavioral therapy for patients with fibromyalgia
Scientific Title
Examination of enhancing the effect of cognitive behavioral therapy for patients with fibromyalgia
Scientific Title:Acronym
Examination of enhancing the effect of cognitive behavioral therapy for patients with fibromyalgia
Region
| Japan |
Condition
Condition
Fibromyalgia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to obtain suggestions for new intervention techniques for patients who are refractory to treatment for fibromyalgia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CPAQ-J
Key secondary outcomes
WSCT,TMT,FAB,A-ADHD,DEX,BPI,PDAS,HADS,PCS,PSEQ,AIS,S, Locomo 25, Physical activity, Sleep time, Pain degree
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
cognitive behavioral therapy (enhanced psychoeducation)
Interventions/Control_2
cognitive behavioral therapy (normal psychoeducation)
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
between 20 and 65 years of age
fibromyalgia
Key exclusion criteria
pain of inflammation
require surgery
under 20 years of age
over 65 years of age
dementia
severe psychiatric disorders
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Kotegawa |
Organization
Ehime University Hospital
Division name
Total medical support center
Zip code
791-0295
Address
shitsukawa Tohon
TEL
0899605917
kotegawa@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Kotegawa |
Organization
Ehime University Hospital
Division name
Total medical support center
Zip code
791-0295
Address
shitsukawa Tohon
TEL
0899605917
Homepage URL
kotegawa@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime university Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ehime University Hospital
Address
shitsukawa, tohon
Tel
0899605917
kotegawa@m.ehime-u.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
| 2021 | Year | 09 | Month | 03 | 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
| 2021 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2024 | 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
| 2021 | Year | 09 | Month | 03 | Day |
Last modified on
| 2021 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051802
| 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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