UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020880 |
|---|---|
| Receipt number | R000024091 |
| Scientific Title | The efficacy of cognitive behavioral therapy for chronic pain: a pilot study |
| Date of disclosure of the study information | 2016/02/05 |
| Last modified on | 2019/08/08 16:12:10 |
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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
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
mshibata@naragakuen.jp
Sponsor or person
Institute
Faculty of Health Science Naragakuen University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024091
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