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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027153
Receipt No. 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

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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
Email 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
Email k.taguchi@chiba-u.jp

Sponsor
Institute Chiba University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031113

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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