UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027153 |
|---|---|
| Receipt number | R000031113 |
| Scientific Title | Clinical trial of individual cognitive Behavioral Therapy for chronic pain (single arm trial) |
| Date of disclosure of the study information | 2017/04/26 |
| Last modified on | 2019/05/30 15:57:26 |
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Basic information
Public title
Clinical trial of individual cognitive Behavioral Therapy for chronic pain (single arm trial)
Acronym
Clinical trial of Cognitive Behavioral Therapy for chronic pain
Scientific Title
Clinical trial of individual cognitive Behavioral Therapy for chronic pain (single arm trial)
Scientific Title:Acronym
Clinical trial of Cognitive Behavioral Therapy for chronic pain
Region
| Japan |
Condition
Condition
Somatic symptom disorder with mainly pain
Classification by specialty
| Psychiatry |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of Cognitive Behavioral Therapy for chronic pain and consideration of Protocol Contents
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Numerical Rating Scale (NRS)
2.Pain Catastrophizing Scale (PCS)
(Both are evaluated after 16 weeks.)
Key secondary outcomes
After 8 weeks,
1.Numerical Rating Scale (NRS)
2.Pain Catastrophizing Scale (PCS)
After 16 weeks,
3.Pain Disability Assessment Scale (PDAS)
4.PHQ-9(Patient Health Questionnare-9)
5.GHQ-7(Generalized anxiety disorder-7)
6.EQ-5D-5L(EuroQol5-Dimension-5Levels)
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
| Maneuver |
Interventions/Control_1
Cognitive Behavioral Therapy(16 weeks)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients falling under all the following conditions are
targeted.
1) Those who satisfy the diagnostic criteria for somatic
symptoms (primary pain) in DSM5 (not excluding
depression or other anxiety disorder).
2) Persons who are 18 years of age or older at the
time of consent acquisition.
3) After being fully informed of participation of this
exam, after fully understanding, it is based on the
individual's willingness to do so. Person who
obtained document consent form
(in case of minors, including parental consent)
4) It can understand cognitive behavioral therapy and
has mental and physical condition that can be
practiced on a sustainable basis for at least 1 year.
Key exclusion criteria
Those who fall under any of the following conditions
are not included.
1) Persons who are expected to have cessation of
behavioral cognitive therapy due to complications
of severe mental disorders such as organic brain
disorder, psychotic disorder, bipolar disorder, drug
dependence etc due to these symptoms worsening
2) Persons who have mental developmental delay
(refer to JART - 25: Japanese Adult Reading Test25)
3) Those with neurocognitive disorders (dementia)
(MMSE: refer to evaluation scores by Mini Mental
State examination)
4) those with autistic spectrum spectroscopy
(AQ: refer to Autism Spectrum Index)
5) Persons who are expected to have cessation of
cognitive behavioral therapy because of the danger
of impending suicide.
6) Persons who are anticipated to have cessation of
cognitive behavioral therapy because they repeat
anti-social behavior.
7) Persons who are predictive of 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.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Chiba University Hospital
Division name
Cognitive Behavior Therapy Center
Zip code
260-8677
Address
Inohana1-8-1 Chuo-ku Chiba-shi Chiba prefecture
TEL
043-226-2027
k.taguchi@chiba-u.jp
Public contact
Name of contact person
| 1st name | Kayoko |
| Middle name | |
| Last name | Taguchi |
Organization
Chiba University
Division name
Cognitive Behavior Physiology Laboratory
Zip code
260-8670
Address
Inohana1-8-1 Chuo-ku Chiba-shi Chiba prefecture
TEL
043-226-2027
Homepage URL
k.taguchi@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Academic contribution
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital
Address
Inohana1-8-1 Chuo-ku Chiba-shi Chiba prefecture
Tel
043-222-7171
chibacrc@mac.com
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
| 2017 | Year | 04 | Month | 26 | 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
17
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
| 2017 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2019 | 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
| 2017 | Year | 04 | Month | 26 | Day |
Last modified on
| 2019 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031113
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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