UMIN-CTR Clinical Trial

Basic information
Public title	Cognitive behavioral therapy for chronic pain in Japan: a randomized controlled trial
Acronym	Cognitive behavioral therapy for chronic pain in Japan: a randomized controlled trial
Scientific Title	Cognitive behavioral therapy for chronic pain in Japan: a randomized controlled trial
Scientific Title:Acronym	Cognitive behavioral therapy for chronic pain in Japan: a randomized controlled trial
Region	Japan

Condition
Condition	Chronic Pain
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study compares the treatment efficacy of individualized cognitive behavioral therapy for chronic pain (CBT-CP) with Treatment-As-Usual (TAU) among Japanese chronic pain patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	1) The change of EuroQol five-dimensional questionnaire five level (EQ5D-5L) (Evaluations are performed at baseline and at 15 +/- 2 weeks after baseline assessment using self-administered questionnaires.)
Key secondary outcomes	2) Medical Outcomes in the 12-Item Short Form Health Survey (SF-12) 3) Numerical Rating Scale (NRS) 4) Pain Disability Assessment Scale (PDAS) 5) Patient Health Questionnaire-9 (PHQ-9) 6) Pain Catastrophizing Scale (PCS) 7) Tampa Scale for Kinesiophobia eleven (TSK-11) 8) Pain Self-Efficacy Questionnaire (PSEQ)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	CBT-CP with TAU: CBT-CP in this study is a structured and manualized eight-session program consisting of psychoeducation, relaxation, activity pacing, cognitive reconstruction, and relapse prevention, supported with the use of a workbook and a worksheet. During this treatment period, the participants continue receiving TAU.
Interventions/Control_2	Waitlist control with TAU: although waitlist participants will not receive CBT-CP during the 15-week waitlist period, they will receive it following the period. While on the waitlist, participants will continue receiving TAU.
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) Chronic pain that has persisted for at least 3 months 2) EQ5D-5L <= 0.80 3) Disability due to chronic pain 4) Age 20-80 years 5) Understanding of the study and signing the consent document of own free will
Key exclusion criteria	1) Receiving other psychotherapy or clinical trial 2) Having previously received CBT to treat chronic pain 3) Schedule to receive medical examination or treatment that may interfere with participation in or results of the study 4) Organic causes of pain requiring immediate medical attention 5) Chronic pain mainly consisting of headache 6) Chronic pain due to surgery or external injury 7) Receipt of compensation or beneficiary of successful lawsuit related to chronic pain 8) Alcohol or substance use disorder 9) Manic episodes or diagnosis of any psychotic disorder 10) Severe suicidal ideation 11) Unable to perform cognitive functions required by CBT 12) Inability or poor ability to communicate, read, or write in Japanese 13) Pregnancy 14) Unsuitability for any other reason, as judged by the attending physician
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Hosogoshi
Organization	Kansai University
Division name	Faculty of Sociology
Zip code	564-8680
Address	3-3-35, Yamate-cho, Suita-shi, Osaka, 564-8680, Japan
TEL	06-6368-1973
Email	hosogosh@kansai-u.ac.jp

Public contact
Name of contact person	1st name Hiroki Middle name Last name Hosogoshi
Organization	Kansai University
Division name	Faculty of Sociology
Zip code	564-8680
Address	3-3-35, Yamate-cho, Suita-shi, Osaka, 564-8680, Japan
TEL	06-6368-1973
Homepage URL	https://jacc-pain.wixsite.com/sanka
Email	hosogosh@kansai-u.ac.jp

Sponsor
Institute	Kansai University
Institute
Department

Funding Source
Organization	The Ministry of Education, Culture, Sports, Science and Technology (MEXT). Japan Society for the Promotion of Science (JSPS). Grant-in-Aid for Scientific Research (B).
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board, Graduate School of Psychology, Kansai University
Address	3-3-35, Yamate-cho, Suita-shi, Osaka, 564-8680, Japan
Tel	06-6368-1121
Email	pcp@ml.kandai.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	Senriyama Hospital (Osaka), National Center of Neurology and Psychiatry Hospital (Tokyo), Kawasaki Medical School Hospital (Okayama), Kobe University Hospital (Hyogo), Jikei University Hospital (Tokyo)

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 01 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	6
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	Terminated
Date of protocol fixation	2019 Year 09 Month 10 Day
Date of IRB	2019 Year 04 Month 14 Day
Anticipated trial start date	2019 Year 12 Month 03 Day
Last follow-up date	2022 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	2019 Year 09 Month 13 Day
Last modified on	2020 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043225