UMIN-CTR Clinical Trial

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
Email	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
Email	kotegawa@m.ehime-u.ac.jp

Sponsor
Institute	Ehime university Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051802