UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027900 |
|---|---|
| Receipt number | R000031961 |
| Scientific Title | Predictors of cognitive behavioral therapy for chronic pain |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2019/12/25 09:16:56 |
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Basic information
Public title
Predictors of cognitive behavioral therapy for chronic pain
Acronym
Predictors of cognitive behavioral therapy for chronic pain
Scientific Title
Predictors of cognitive behavioral therapy for chronic pain
Scientific Title:Acronym
Predictors of cognitive behavioral therapy for chronic pain
Region
| Japan |
Condition
Condition
chronic pain
Classification by specialty
| Psychiatry | Anesthesiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examine the predictors of pain symptoms, pain disability, or quality of life during cognitive behavioral therapy for chronic pain
Basic objectives2
Others
Basic objectives -Others
I. To examine the baseline predictors of pain symptoms, pain disability, or quality of life during cognitive behavioral therapy for chronic pain
II. To examine the relationship between the changes in clinical factors and the chages in pain symptoms, pain disability, or quality of life during cognitive behavioral therapy for chronic pain
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Numerical Rating Scale (NRS)
Key secondary outcomes
Short-Form McGill Pain Quetionnaire2(SF-MPQ-2), Pain Catastrophizing Scale(PCS),Pain Self-Efficacy Questionnaire(PSEQ),Hospital Anxiety and Depression Scale(HADS),Somatic Symptom Scale-8(SSS-8),Behavioral Approach System / Behavioral Inhibition System Scales (BAS/BIS Scales), Effortful Control Scale for Ad1ults(ECS),Pain Disability Assessment Scale(PDAS),EuroQol-5 Dimensions-5 Level (EQ-5D-5L)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
cognitive behavioral therapy, once a week,two hours, twelve sessions
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)outpatients of pain center in Nogoya City University Hospital
2)chronic pain without organic disease
3)more than three months durartion
Key exclusion criteria
developmental disorder, current psychosis, bipolar disorder and substance-use disorder.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Sei |
| Middle name | |
| Last name | Ogawa |
Organization
Nagoya City University
Division name
Graduate School of Humanities and Social Sciences
Zip code
467-8501
Address
Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL
052-872-5186
seiogawa1964@nifty.com
Public contact
Name of contact person
| 1st name | Sei |
| Middle name | |
| Last name | Ogawa |
Organization
Nagoya City University
Division name
Graduate School of Humanities and Social Sciences
Zip code
467-8501
Address
Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL
052-872-5186
Homepage URL
seiogawa1964@nifty.com
Sponsor or person
Institute
Graduate School of Humanities and Social Sciences Nagoya City University
Institute
Department
Personal name
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
Nagoya City University
Address
Mizuho-cho, Mizuho-ku, Nagoya, Japan
Tel
052-851-5511
clinical_research@med.nagoya-cu.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
| 2017 | Year | 07 | 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
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
| 2017 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 23 | Day |
Last modified on
| 2019 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031961
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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