UMIN-CTR Clinical Trial

Basic information
Public title	Development of Internet-based Cognitive Behavioral Therapy for Chronic Non-Cancer Pain
Acronym	Internet-based Cognitive Behavioral Therapy for Chronic Non-Cancer Pain
Scientific Title	Internet-based Cognitive Behavioral Therapy for Chronic Non-Cancer Pain using Ecological Momentary Assessment
Scientific Title:Acronym	Internet-based Cognitive Behavioral Therapy for Chronic Non-Cancer Pain
Region	Japan

Condition
Condition	Chronic non-cancer pain
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the effectiveness of internet-based cognitive behavioral therapy (iCBT) for chronic non-cancer pain. Assessments will include ecological momentary assessment (EMA) in addition to conventional self-report measures of pain and pain-related symptoms. Effects of the iCBT on brain function will also be measured using a functional magnetic resonance imaging (fMRI).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in patient self-reported pain intensity on 11 point (0-10) numerical rating scale (NRS)
Key secondary outcomes	-Changes in psychological state and pain-related physical impairment -Changes in fMRI -Changes in EMA

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	Behavior,custom
Interventions/Control_1	-Internet-based cognitive behavioral therapy for chronic pain is a manualized program that consists of 7 weekly or biweekly sessions (maximum of three months). -Each session will be delivered at our hospital under the guidance of a trained therapist. -Assessments will include self-report measures, fMRI and EMA that will take place at pre-treatment, post treatment, 6-month follow up and 12-month follow up.
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Chronic non-cancer pain; pain for more than 3 months 2) Unresponsive to conventional medications and nerve blocks (more than 2 months)
Key exclusion criteria	1) Candidate for surgery 2) History of anomalies of the central nervous system 3) Current psychiatric or neurological illness 4) Cognitive impairment
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Shizuko Middle name Last name Kosugi
Organization	Keio University School of Medicine
Division name	Department of Anesthesiology
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3107
Email	kosugi.z6@keio.jp

Public contact
Name of contact person	1st name Kenta Middle name Last name Wakaizumi
Organization	Keio University School of Medicine
Division name	Department of Anesthesiology
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL	03-5363-3107
Homepage URL
Email	kwaka@keio.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Keio University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Keio University School of Medicine Ethics Committee
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
Tel	03-3353-1211
Email	med-rinri-jimu@adst.keio.ac.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	2021 Year 04 Month 07 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	Preinitiation
Date of protocol fixation	2021 Year 03 Month 04 Day
Date of IRB	2021 Year 03 Month 30 Day
Anticipated trial start date	2021 Year 05 Month 01 Day
Last follow-up date	2024 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	2021 Year 04 Month 05 Day
Last modified on	2021 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050042

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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