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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000038010
Receipt No. R000043225
Scientific Title Cognitive behavioral therapy for chronic pain in Japan: a randomized controlled trial
Date of disclosure of the study information 2019/10/01
Last modified on 2020/12/21

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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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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