UMIN-CTR Clinical Trial

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
Email	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
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)

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038248