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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033624
Receipt No. R000038248
Official scientific title of the study 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 2018/08/03

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Basic information
Official scientific title of the study The feasibility study of short-time cognitive behavioral therapy for chronic pain: open label pilot study
Title of the study (Brief title) 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 Masaru Horikoshi
Organization National Center of Neurology and Psychiatry
Division name National Center for Cognitive Behavior Therapy and Research
Address 4-1-1 Ogawahigashicho,Kodaira,Tokyo 187-8551 Japan
TEL 042-341-2711
Email mhorikoshi@ncnp.go.jp

Public contact
Name of contact person Yuki Oe
Organization National Center of Neurology and Psychiatry
Division name National Center for Cognitive Behavior Therapy and Research
Address 4-1-1 Ogawahigashicho,Kodaira,Tokyo 187-8551 Japan
TEL 042-341-2711
Homepage URL
Email yukioe@ncnp.go.jp

Sponsor
Institute National Center for Cognitive Behavior Therapy and Research Chronic Pain Study team
Institute
Department

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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 11 Month 24 Day
Anticipated trial start date
2018 Year 02 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 03 Day
Last modified on
2018 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038248

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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