UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033624 |
|---|---|
| Receipt number | R000038248 |
| Scientific Title | The feasibility study of short-time cognitive behavioral therapy for chronic pain: open label pilot study |
| Date of disclosure of the study information | 2018/08/03 |
| Last modified on | 2021/02/03 11:16:34 |
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Basic information
Public title
The feasibility study of short-time cognitive behavioral therapy for chronic pain: open label pilot study
Acronym
An open label pilot study of the short-time cognitive behavioral therapy for chronic pain
Scientific Title
The feasibility study of short-time cognitive behavioral therapy for chronic pain: open label pilot study
Scientific Title:Acronym
An open label pilot study of the short-time cognitive behavioral therapy for chronic pain
Region
| Japan |
Condition
Condition
chronic pain
Classification by specialty
| Medicine in general | Neurology | Clinical immunology |
| Psychosomatic Internal Medicine | Psychiatry | Orthopedics |
| Anesthesiology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and feasibility of short-time cognitive behavioral therapy for chronic pain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
EQ-5D-5L
(Evaluations are performed at baseline and end of the CBT treatment.)
Key secondary outcomes
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
Multiple Pain Inventory
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
| Maneuver |
Interventions/Control_1
Short-time CBT for chronic pain (10-15 minutes per session, 8sessions)
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 the symptoms of chronic pain for at least three months
2. patients who understand the aim and contents of this trial and voluntary give written informed consent
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 compensation or suits
8. patients who unable to visit a predetermined number of times within the research period
9. patients who are judged inappropriate to the research by the attending physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Horikoshi |
Organization
National Center of Neurology and Psychiatry
Division name
National Center for Cognitive Behavior Therapy and Research
Zip code
187-8551
Address
4-1-1 Ogawahigashicho,Kodaira,Tokyo 187-8551 Japan
TEL
042-341-2711
mhorikoshi@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Oe |
Organization
National Center of Neurology and Psychiatry
Division name
National Center for Cognitive Behavior Therapy and Research
Zip code
187-8551
Address
4-1-1 Ogawahigashicho,Kodaira,Tokyo 187-8551 Japan
TEL
042-341-2711
Homepage URL
yukioe@ncnp.go.jp
Sponsor or person
Institute
National Center for Cognitive Behavior Therapy and Research Chronic Pain Study team
Institute
Department
Personal name
Funding Source
Organization
National Center of Neurology and Psychiatry
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
National Center of Neurology and Psychiatry
Address
4-1-1 Ogawahigashicho,Kodaira,Tokyo 187-8551 Japan
Tel
042-341-2711
rinri-jimu@ncnp.go.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
| 2018 | Year | 08 | Month | 03 | 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
| 2017 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 03 | Day |
Last modified on
| 2021 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038248
