UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031124 |
|---|---|
| Receipt number | R000035546 |
| Scientific Title | Effect of Internet-based Cognitive Behavioral Therapy for chronic pain :Pilot Randomized Controlled Trial |
| Date of disclosure of the study information | 2018/02/02 |
| Last modified on | 2020/09/18 17:33:16 |
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Basic information
Public title
Effect of Internet-based Cognitive Behavioral Therapy for chronic pain :Pilot Randomized Controlled Trial
Acronym
RCT of remote Cognitive Behavioral Therapy for chronic pain
Scientific Title
Effect of Internet-based Cognitive Behavioral Therapy for chronic pain :Pilot Randomized Controlled Trial
Scientific Title:Acronym
RCT of remote Cognitive Behavioral Therapy for chronic pain
Region
| Japan |
Condition
Condition
Somatic symptom disorder mainly pain
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify that the Internet-based cognitive behavioral therapy (vCBT) significantly decreases the Numerical Rating Scale (pain intensity) of chronic pain patients compared to treatment as usual (TAU).
Basic objectives2
Others
Basic objectives -Others
Medical Economic Evaluation by Internet-Based Cognitive Behavior Therapy
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numerical Rating Scale (NRS)
Key secondary outcomes
1) EQ-5D-5L(EuroQol5-Dimension-5Levels)
2) BPI-J(Brief Pain Inventory)
3) PCS(Pain Catastrophizing Scale)
4) PDAS(Pain Disability Assessment scale)
5) BDI-2(Beck Depression Inventory)
6) PHQ-9(Patient Health Questionnare-9)
7) GHQ-7(Generalized anxiety disorder-7)
8) CGI-C(Clinical Global Impression of Change Scale)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Internet-Based Cognitive Behavioral Therapy(16weeks)
Interventions/Control_2
Treatment as usual(16weeks)
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients falling under all the following conditions are
targeted.
1) Treatment of "somatic symptoms (pain of main symptoms)" in DSM-5 Person satisfying abandonment.
2) Chronic pain is a primary complaint that can not be explained by mental illness even if there is a complication of depression or other anxiety disorder).
3) Persons who are aged over the age of eighty and over 75 years.
4) After sufficiently describing the participation of this exam, after sufficient understanding, it is based on the individual's willingness to do so. Person who got the written consent form (In the case of a minor, you can include the consent of parents can be unnecessary)
5) Persons who have mental and physical conditions that can be practiced on a sustained basis for a minimum of 4 months by understanding cognitive behavioral therapy.
6) Persons who have Internet and computer environments that can accept remote cognitive behavioral therapy (vCBT) by videoconference.
7) Regarding medicinal therapy for chronic pain, (1) I wanted to accept one or more sufficient period (8 weeks or more) enough, I wanted to suggest a marked - to - moderate improvement, or (2)one or more medications due to problems of tolerability Those who tried to demonstrate improvement from moderate to moderate.
8) General treatment for chronic pain (periodic interview with the doctor within 8 weeks is essential and the effect of the medicine is not concerned) is carried out, during the examination, drugs corresponding to chronic pain No new start or additional changes of therapy are planned.
Key exclusion criteria
It does not cover those who fall under any of the following
1) Combination of serious mental disorders such as neurocognitive disorder group of DSM-5, psychotic disorder, bipolar disorder, substance-related disorder and so on, interruption of cognitive behavior therapy is expected due to these symptoms worsening Person.
2) The major pain factor is cancer pain.
3) A person who does not show clear QOL decline even with chronic pain (PDAS: Pain Disability Assessment Scale refers to the score such as 9 or less).
4) Persons with mental retardation, those with neurocognitive disorders (dementia), those with autistic spectrum spectroscopy, and therefore for which cognitive behavioral therapy is expected to be difficult. In case
5) Persons who have the danger of imminent suicide and are expected to interrupt cognitive behavioral therapy.
6) Persons who are anticipated to have cessation of cognitive behavioral therapy because they repeat anti-social behavior.
7) Persons who are expected to have cessation of cognitive behavioral therapy because they have significant progressive physical disorder.
8) Persons who are difficult to contact with researchers.
9) Other persons who are judged inappropriate for the examination responsible doctor or the test sharing psychologist to safely carry out this test.
10) Person who involves litigation or compensation concerning pain symptoms.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Shimizu |
Organization
Chiba University
Division name
Cognitive Behavior Physiology Laboratory
Zip code
Address
Inohana1-8-1 Chuo-ku Chiba-shi Chiba prefecture
TEL
043-226-2028
k.taguchi@chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kayoko Taguchi |
Organization
Chiba University
Division name
Cognitive Behavior Physiology Laboratory
Zip code
Address
Inohana1-8-1 Chuo-ku Chiba-shi Chiba prefecture
TEL
043-226-2028
Homepage URL
k.taguchi@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare Scientific Research Expenses
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
Address
Tel
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
| 2018 | Year | 02 | Month | 02 | 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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2018 | Year | 02 | Month | 02 | Day |
Last modified on
| 2020 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035546
