UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042798 |
|---|---|
| Receipt number | R000048858 |
| Scientific Title | Cognitive behavioral therapy for chronic pain in Japan: a randomized controlled trial |
| Date of disclosure of the study information | 2020/12/21 |
| Last modified on | 2023/08/01 11:59:46 |
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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
| Psychosomatic Internal Medicine | Psychiatry | Rehabilitation medicine |
| 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. Although CBT-CP is basically delivered face-to-face, it is delivered remotely only if specified conditions are met.
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
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
hosogosh@kansai-u.ac.jp
Sponsor or person
Institute
Kansai University
Institute
Department
Personal name
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
Osaka University Clinical Research Review Committee
Address
2-2, Yamadaoka, Suita-shi, Osaka, 565-0871, Japan
Tel
06-6210-8289
rinri@hp-crc.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
Senriyama Hospital (Osaka), National Center of Neurology and Psychiatry Hospital (Tokyo), Kawasaki Medical School Hospital (Okayama), Kobe University Hospital (Hyogo), Jikei University Hospital (Tokyo), Hiroshima University Hospital (Hiroshima), Nara Medical University Hospital (Nara)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 21 | 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
| 2020 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2020 | Year | 12 | Month | 21 | Day |
Last modified on
| 2023 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048858
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
