UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043846 |
|---|---|
| Receipt number | 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 | 2022/04/27 11:38:38 |
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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
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
kwaka@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
| 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
Enrolling by invitation
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
| 2022 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050042
