UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of cognitive behavioral therapy for chronic pain: a pilot study
Acronym	The study of cognitive behavioral therapy for chronic pain
Scientific Title	The efficacy of cognitive behavioral therapy for chronic pain: a pilot study
Scientific Title:Acronym	The study of cognitive behavioral therapy for chronic pain
Region	Japan

Condition
Condition	chronic pain
Classification by specialty	Medicine in general Neurology Clinical immunology Psychosomatic Internal Medicine Orthopedics Anesthesiology Rehabilitation medicine Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this research is to examine the effects of cognitive behavioral therapy for chronic pain.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	EQ-5D-5L Evaluations are performed at baseline, end of the CBT treatment, and 6-month follow-up.
Key secondary outcomes	SF-12 Numerical Rating Scale Pain Disability Assessment Scale Patient Health Questionnaire-9 Pain Catastrophizing Scale Tampa Scale for Kinesiophobia eleven Pain Self-Efficacy Questionnaire Keele STarT Back Screening Tool generic condition Somatic Symptom Scale-8

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	A 30-min treatment program of cognitive behavioral therapy is conducted eight times. The interval between sessions is one or two weeks.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1. patients who have daily-life difficulty caused by chronic pain for at least three months 2. patients who consent to participate in the research
Key exclusion criteria	1. patients who have need medical treatment rapidly 2. patients who have alcohol abuse or drug abuse 3. patients who have mental disease such as hypomania, mania, psychotic disorder 4. patients who have significant suicidal ideation 5. patients who have cognitive dysfunction such as delirium, dementia, mental retardation 6. patients who are difficult to communicate with Japanese 7. patients who have chronic pain because of accident or surgery 8. patients who have compensation or suits 9. patients who select 10 score in numerical rating scale 10. patients who are judged inappropriate to the research by the attending physician
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Masahiko Middle name Last name Shibata
Organization	Naragakuen University
Division name	Faculty of Health Science
Zip code	6318524
Address	3-15-1 Tomigaoka, Nara-shi, Nara, 631-8524, Japan
TEL	0742-95-9800
Email	mshibata@naragakuen.jp

Public contact
Name of contact person	1st name Masahiko Middle name Last name Shibata
Organization	Naragakuen University
Division name	Faculty of Health Science
Zip code	6318524
Address	3-15-1 Tomigaoka, Nara-shi, Nara, 631-8524, Japan
TEL	0742-95-9800
Homepage URL
Email	mshibata@naragakuen.jp

Sponsor
Institute	Faculty of Health Science Naragakuen University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development(AMED)
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	Osaka University Clinical Research Review Committee
Address	2-2 Yamadaoka Suita Osaka Japan 565-0871
Tel	06-6210-8289
Email	mirai@hp-mctr.med.osaka-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	篤友会千里山病院（大阪府） 国立精神・神経医療研究センター　認知行動療法センター（東京都） 東京慈恵医科大学麻酔科ペインクリニック（東京都） 川﨑医科大学附属病院麻酔・集中治療科（岡山県） 神戸大学医学部附属病院麻酔科・ペインクリニック科（兵庫県）

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 05 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	Completed
Date of protocol fixation	2016 Year 02 Month 04 Day
Date of IRB	2016 Year 03 Month 17 Day
Anticipated trial start date	2016 Year 11 Month 01 Day
Last follow-up date	2018 Year 01 Month 23 Day
Date of closure to data entry	2018 Year 01 Month 23 Day
Date trial data considered complete	2018 Year 01 Month 23 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 02 Month 04 Day
Last modified on	2019 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024091