UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043982 |
|---|---|
| Receipt number | R000048658 |
| Scientific Title | Development of an online CBT for chronic pain patients and examination of the neural mechanisms |
| Date of disclosure of the study information | 2021/04/21 |
| Last modified on | 2022/10/21 11:50:40 |
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Basic information
Public title
Development of an online CBT for chronic pain patients and examination of the neural mechanisms
Acronym
Online CBT for chronic pain patients
Scientific Title
Development of an online CBT for chronic pain patients and examination of the neural mechanisms
Scientific Title:Acronym
Online CBT for chronic pain patients
Region
| Japan |
Condition
Condition
Chronic pain
Classification by specialty
| Medicine in general | Surgery in general | Psychiatry |
| Orthopedics | Anesthesiology | Neurosurgery |
| Rehabilitation medicine | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We treat chronic pain patients by using an online CBT, and we examine an effectiveness of the treatment by comparing with a face to face CBT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective pain intensity (Numeric rating scale; NRS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Cognitive Behavioral Therapy
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Endorse having pain as a daily life problem in the past 6 months
(2) Meet criteria for having a chronic pain problem (3 months or higher, with pain experienced on 50% or higher of days in past 6 months)
(3) Average intensity of chronic pain 30 or higher on a 100-point scale for 45 or higher days of the previous 3 months
(4) Availability of a telephone, webcam, and microphone through computer or telephone, as well as daily internet access
(5) Acquired informed consent
Key exclusion criteria
(1) Severe cognitive impairment such as dementia, or patients with delusion, hallucination, manic state, suicidal ideation, and psychosis
(2) Severe somatic illnesses
(3) Brain organic disorders
(4) Current alcohol or substance dependence
(5) Cases of staff members judging as being unqualified
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Yasumasa |
| Middle name | |
| Last name | Okamoto |
Organization
Hiroshima University
Division name
Psychiatry
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
0822575207
oy@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsuo |
| Middle name | Yoshino |
| Last name | Yoshino |
Organization
Hiroshima University
Division name
Health Service Center
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
0822575479
Homepage URL
https://www.seisin.hiroshima-u.ac.jp/03_group_7_mtotsu.html
yoshino@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
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
Clinical Research Center in Hiroshima, Hiroshima University
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
Tel
0822571551
iryo-seisaku@office.hiroshima-u.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 | 21 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 12 | 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 | 20 | Day |
Last modified on
| 2022 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048658
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
