UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Internet-based Cognitive Behavioral Therapy for chronic pain :Pilot Randomized Controlled Trial
Acronym	RCT of remote Cognitive Behavioral Therapy for chronic pain
Scientific Title	Effect of Internet-based Cognitive Behavioral Therapy for chronic pain :Pilot Randomized Controlled Trial
Scientific Title:Acronym	RCT of remote Cognitive Behavioral Therapy for chronic pain
Region	Japan

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

Objectives
Narrative objectives1	To verify that the Internet-based cognitive behavioral therapy (vCBT) significantly decreases the Numerical Rating Scale (pain intensity) of chronic pain patients compared to treatment as usual (TAU).
Basic objectives2	Others
Basic objectives -Others	Medical Economic Evaluation by Internet-Based Cognitive Behavior Therapy
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Numerical Rating Scale (NRS)
Key secondary outcomes	1) EQ-5D-5L(EuroQol5-Dimension-5Levels) 2) BPI-J(Brief Pain Inventory) 3) PCS(Pain Catastrophizing Scale) 4) PDAS(Pain Disability Assessment scale) 5) BDI-2(Beck Depression Inventory) 6) PHQ-9(Patient Health Questionnare-9) 7) GHQ-7(Generalized anxiety disorder-7) 8) CGI-C(Clinical Global Impression of Change Scale)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Internet-Based Cognitive Behavioral Therapy(16weeks)
Interventions/Control_2	Treatment as usual(16weeks)
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients falling under all the following conditions are targeted. 1) Treatment of "somatic symptoms (pain of main symptoms)" in DSM-5 Person satisfying abandonment. 2) Chronic pain is a primary complaint that can not be explained by mental illness even if there is a complication of depression or other anxiety disorder). 3) Persons who are aged over the age of eighty and over 75 years. 4) After sufficiently describing the participation of this exam, after sufficient understanding, it is based on the individual's willingness to do so. Person who got the written consent form (In the case of a minor, you can include the consent of parents can be unnecessary) 5) Persons who have mental and physical conditions that can be practiced on a sustained basis for a minimum of 4 months by understanding cognitive behavioral therapy. 6) Persons who have Internet and computer environments that can accept remote cognitive behavioral therapy (vCBT) by videoconference. 7) Regarding medicinal therapy for chronic pain, (1) I wanted to accept one or more sufficient period (8 weeks or more) enough, I wanted to suggest a marked - to - moderate improvement, or (2)one or more medications due to problems of tolerability Those who tried to demonstrate improvement from moderate to moderate. 8) General treatment for chronic pain (periodic interview with the doctor within 8 weeks is essential and the effect of the medicine is not concerned) is carried out, during the examination, drugs corresponding to chronic pain No new start or additional changes of therapy are planned.
Key exclusion criteria	It does not cover those who fall under any of the following 1) Combination of serious mental disorders such as neurocognitive disorder group of DSM-5, psychotic disorder, bipolar disorder, substance-related disorder and so on, interruption of cognitive behavior therapy is expected due to these symptoms worsening Person. 2) The major pain factor is cancer pain. 3) A person who does not show clear QOL decline even with chronic pain (PDAS: Pain Disability Assessment Scale refers to the score such as 9 or less). 4) Persons with mental retardation, those with neurocognitive disorders (dementia), those with autistic spectrum spectroscopy, and therefore for which cognitive behavioral therapy is expected to be difficult. In case 5) Persons who have the danger of imminent suicide and are expected to interrupt cognitive behavioral therapy. 6) Persons who are anticipated to have cessation of cognitive behavioral therapy because they repeat anti-social behavior. 7) Persons who are expected to have 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. 10) Person who involves litigation or compensation concerning pain symptoms.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Eiji Shimizu
Organization	Chiba University
Division name	Cognitive Behavior Physiology Laboratory
Zip code
Address	Inohana1-8-1 Chuo-ku Chiba-shi Chiba prefecture
TEL	043-226-2028
Email	k.taguchi@chiba-u.jp

Public contact
Name of contact person	1st name Middle name Last name Kayoko Taguchi
Organization	Chiba University
Division name	Cognitive Behavior Physiology Laboratory
Zip code
Address	Inohana1-8-1 Chuo-ku Chiba-shi Chiba prefecture
TEL	043-226-2028
Homepage URL
Email	k.taguchi@chiba-u.jp

Sponsor
Institute	Chiba University Hospital
Institute
Department

Funding Source
Organization	Ministry of Health, Labor and Welfare Scientific Research Expenses
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 02 Month 02 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	2018 Year 01 Month 22 Day
Date of IRB	2018 Year 01 Month 25 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2020 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	2018 Year 02 Month 02 Day
Last modified on	2020 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035546