UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trial of individual cognitive Behavioral Therapy for chronic pain (single arm trial)
Acronym	Clinical trial of Cognitive Behavioral Therapy for chronic pain
Scientific Title	Clinical trial of individual cognitive Behavioral Therapy for chronic pain (single arm trial)
Scientific Title:Acronym	Clinical trial of Cognitive Behavioral Therapy for chronic pain
Region	Japan

Condition
Condition	Somatic symptom disorder with mainly pain
Classification by specialty	Psychiatry
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Efficacy of Cognitive Behavioral Therapy for chronic pain and consideration of Protocol Contents
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.Numerical Rating Scale (NRS) 2.Pain Catastrophizing Scale (PCS) (Both are evaluated after 16 weeks.)
Key secondary outcomes	After 8 weeks, 1.Numerical Rating Scale (NRS) 2.Pain Catastrophizing Scale (PCS) After 16 weeks, 3.Pain Disability Assessment Scale (PDAS) 4.PHQ-9(Patient Health Questionnare-9) 5.GHQ-7(Generalized anxiety disorder-7) 6.EQ-5D-5L(EuroQol5-Dimension-5Levels)

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	Cognitive Behavioral Therapy(16 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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients falling under all the following conditions are targeted. 1) Those who satisfy the diagnostic criteria for somatic symptoms (primary pain) in DSM5 (not excluding depression or other anxiety disorder). 2) Persons who are 18 years of age or older at the time of consent acquisition. 3) After being fully informed of participation of this exam, after fully understanding, it is based on the individual's willingness to do so. Person who obtained document consent form (in case of minors, including parental consent) 4) It can understand cognitive behavioral therapy and has mental and physical condition that can be practiced on a sustainable basis for at least 1 year.
Key exclusion criteria	Those who fall under any of the following conditions are not included. 1) Persons who are expected to have cessation of behavioral cognitive therapy due to complications of severe mental disorders such as organic brain disorder, psychotic disorder, bipolar disorder, drug dependence etc due to these symptoms worsening 2) Persons who have mental developmental delay (refer to JART - 25: Japanese Adult Reading Test25) 3) Those with neurocognitive disorders (dementia) (MMSE: refer to evaluation scores by Mini Mental State examination) 4) those with autistic spectrum spectroscopy (AQ: refer to Autism Spectrum Index) 5) Persons who are expected to have cessation of cognitive behavioral therapy because of the danger of impending suicide. 6) Persons who are anticipated to have cessation of cognitive behavioral therapy because they repeat anti-social behavior. 7) Persons who are predictive of cessation of cognitive behavioral therapy because they have significant progressive physical disorder. 8) Persons who are difficult to contact with researchers. 9) Other persons who are judged inappropriate for the examination responsible doctor or the test sharing psychologist to safely carry out this test.
Target sample size	15

Research contact person
Last name of lead principal investigator	1st name Eiji Middle name Last name Shimizu
Organization	Chiba University Hospital
Division name	Cognitive Behavior Therapy Center
Zip code	260-8677
Address	Inohana1-8-1 Chuo-ku Chiba-shi Chiba prefecture
TEL	043-226-2027
Email	k.taguchi@chiba-u.jp

Public contact
1st name of contact person	1st name Kayoko Middle name Last name Taguchi
Organization	Chiba University
Division name	Cognitive Behavior Physiology Laboratory
Zip code	260-8670
Address	Inohana1-8-1 Chuo-ku Chiba-shi Chiba prefecture
TEL	043-226-2027
Homepage URL
Email	k.taguchi@chiba-u.jp

Sponsor
Institute	Chiba University Hospital
Institute
Department

Funding Source
Organization	Academic contribution
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	Chiba University Hospital
Address	Inohana1-8-1 Chuo-ku Chiba-shi Chiba prefecture
Tel	043-222-7171
Email	chibacrc@mac.com

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 04 Month 26 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	17
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 04 Month 18 Day
Date of IRB	2017 Year 03 Month 22 Day
Anticipated trial start date	2017 Year 05 Month 09 Day
Last follow-up date	2019 Year 03 Month 31 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 04 Month 26 Day
Last modified on	2019 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031113