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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043846
Receipt No. R000050042
Scientific Title Internet-based Cognitive Behavioral Therapy for Chronic Non-Cancer Pain using Ecological Momentary Assessment
Date of disclosure of the study information 2021/04/07
Last modified on 2021/04/06

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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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