UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057906 |
|---|---|
| Receipt number | R000066183 |
| Scientific Title | A Randomized Controlled Trial of Internet-based Cognitive Behavioral Therapy for Chronic Non-cancer Pain |
| Date of disclosure of the study information | 2025/05/20 |
| Last modified on | 2025/05/20 14:17:10 |
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Basic information
Public title
Evaluation of the Effectiveness of Internet-based Cognitive Behavioral Therapy for Chronic Non-Cancer Pain
Acronym
Internet-based Cognitive Behavioral Therapy for Chronic Non-Cancer Pain
Scientific Title
A Randomized Controlled Trial of Internet-based Cognitive Behavioral Therapy for Chronic Non-cancer Pain
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 patients with chronic non-cancer pain.Assessments include conventional clinical outcome measures related to pain, molecular biological analysis using exosomes, brain activity measured by electroencephalogram and functional neuroimaging with functional Magnetic Resonance Imaging (fMRI). The study aims to determine whether there are differences in treatment effects and prognosis between the intervention and control groups, and whether these outcomes are associated with brain function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in patient self-reported pain intensity measured by the Visual Analogue Scale (VAS, 0 - 100)
Key secondary outcomes
1. Changes in psychological state and pain-related physical impairment
2. Changes in electroencephalogram (EEG) and functional Magnetic Resonance Imaging (fMRI)
3. Changes in exosomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Common procedures for both intervention and control groups:
1. The internet-based cognitive behavioral therapy (iCBT) used in this study consists of eight sessions, conducted weekly or biweekly over a maximum of four months, based on an original standardized manual.
2. All sessions are conducted in a private room within the Pain Management Center in our hospital, with a trained therapist.
3. In this study, participants in both groups will undergo a total of three evaluations. Evaluation refers to the obtaining pain-related questionnaires, electroencephalogram (EEG), Magnetic Resonance Imaging (MRI), and blood sampling. These procedures are collectively referred to as evaluation hereafter.
Intervention group:
1. The first evaluation is conducted after obtaining informed consent for enrollment of the study.
2. Participants then undergo the iCBT sessions.
3. The second evaluation is conducted after completing all the iCBT sessions.
4. The third evaluation is conducted after a four-month follow-up period.
Interventions/Control_2
Common procedures for both intervention and control groups:
1. The internet-based cognitive behavioral therapy (iCBT) used in this study consists of eight sessions, conducted weekly or biweekly over a maximum of four months, based on an original standardized manual.
2. All sessions are conducted in a private room within the Pain Management Center in our hospital, with a trained therapist.
3. In this study, participants in both groups will undergo a total of three evaluations. Evaluation refers to the obtaining pain-related questionnaires, electroencephalogram (EEG), Magnetic Resonance Imaging (MRI), and blood sampling. These procedures are collectively referred to as evaluation hereafter.
Control group:
1. The first evaluation is conducted after obtaining informed consent for enrollment of the study.
2. The second evaluation is conducted after a four-month waiting period.
3. Participants then undergo the iCBT sessions.
4. The third evaluation is conducted after completing the iCBT sessions.
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Aged between 20 and 74 years.
2. Patients with chronic pain lasting for more than three months and with a pain intensity of 4 or higher on the Numerical Rating Scale (NRS).
3. Patients who have not responded to standard pharmacological treatment and nerve block therapy for at least two months.
4. Patients diagnosed with primary chronic pain through a multidisciplinary conference at Interdisciplinary Pain Center in our hospital.
5. Patients who can provide written informed consent based on their own free will.
Key exclusion criteria
1. Patients who are eligible for surgical treatment.
2. Patients with a history of anomalies of the central nervous system
3. Patients with severe psychiatric disorders or having conditions such as epilepsy.
4. Patients with cognitive impairment.
5. Patients who do not have a device to access to internet web site.
6. Patients who are unable to undergo MRI (e.g., due to claustrophobia or presence of metal in the body).
7. Patients who are unable to complete all eight sessions within a four-month period.
Target sample size
80
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
kosugi.z6@keio.jp
Public contact
Name of contact person
| 1st name | Morihiko |
| Middle name | |
| Last name | Kawate |
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
morihikok2@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
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
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
| 2025 | Year | 05 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 05 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2025 | Year | 05 | Month | 19 | Day |
Last modified on
| 2025 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066183
