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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035086
Receipt No. R000039980
Scientific Title Effect of Cognitive Behavioral Therapy for chronic pain: Additional Study for the Control Group in the RCT(UMIN000031124)
Date of disclosure of the study information 2018/12/15
Last modified on 2019/04/24

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Basic information
Public title Effect of Cognitive Behavioral Therapy for chronic pain: Additional Study for the Control Group in the RCT(UMIN000031124)
Acronym Cognitive Behavioral Therapy for chronic pain : Additional Study for the Control Group in the RCT(UMIN000031124)
Scientific Title Effect of Cognitive Behavioral Therapy for chronic pain: Additional Study for the Control Group in the RCT(UMIN000031124)
Scientific Title:Acronym Cognitive Behavioral Therapy for chronic pain : Additional Study for the Control Group in the RCT(UMIN000031124)
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 cognitive behavioral therapy (CBT) significantly decreases the Numerical Rating Scale (pain intensity) of chronic pain patients, who had participated as TAU(Treatment as usual) group in the previous study "RCT of remote Cognitive Behavioral Therapy for chronic pain" and whose chronic pain symptoms are still remained after the study .
Basic objectives2 Others
Basic objectives -Others Can get more information to prove the evidence, by the increase of the patient taking part in the clinical study.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Numerical Rating Scale(NRS)
(1week, 8week, 16week)
Key secondary outcomes 1)BPI-J(Brief Pain Inventory)
2)PCS(Pain Catastrophizing Scale)
3)PDAS(Pain Disability Assessment scale)
4)BDI-II(Beck Depression Inventory)
5)PHQ-9(Patient Health Questionnare-9)
6)GAD-7(Generalized anxiety disorder-7)
7)PSPS(Pain Self Perception Scale)
8)IEQ-chr(Injustice Experience Questionnaire chronic)
9)CSQ-8(Client Satisfaction Questionnaire)
10)CGI-C(Clinical Global Impression of Change Scale)
11)Pain Image(semi-structured interview)data

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 behavior 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
75 years-old >=
Gender Male and Female
Key inclusion criteria Patients who participated as TAU(Treatment as usual)group in the previous study "RCT of remote Cognitive Behavioral Therapy for chronic pain" and whose chronic pain symptoms is still remained.
Patients following all the conditions below are included.
1) Meet the criteria of "somatic symptoms (pain of main symptoms)" in DSM-5.
2) Chronic pain is the primary complaint that cannot be explained by mental illness even if there is a complication of depression or other anxiety disorder.
3) Aged between 18 and 75 years.
4)Having received adequate explanation of the exam and given their written consent, based on the individual's willingness.(In the case of a minor, informed consent of the parents will be needed but informed assent is unnecessary)
5) Persons who can understand cognitive behavior therapy, and have mental and physical conditions that can keep practicing the therapy.
6)Regarding medicinal therapy for chronic pain, (1)Having accepted one or more sufficient medicine in a sufficient period (8 weeks or more) and not showing moderate-to marked improvement, or (2)cannot take one or more medications due to problems of tolerability and those not showing moderate to marked improvements.
7) Not planning to change or start another medicine on chronic pain during general treatment for chronic pain (periodic interview with the doctor within 8 weeks is essential and the effect of the medicine at the time of the entry is not concerned).
Key exclusion criteria Patients who correspond to the condition below will be excluded.
1) Combination of serious mental disorders such as neurocognitive disorder group in DSM-5, psychotic disorder, bipolar disorder, substance-related disorder and so on, and whose interruption of cognitive behavior therapy is expected due to these worsen symptoms.
2) The major pain factor is cancer pain.
3) 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) Those expected to be difficult to practice cognitive behavioral therapy regarding the diagnosis below. Mental retardation, Neurocognitive disorders (dementia),Autistic spectrum spectroscopy.
5) Who have the danger of imminent suicide and are expected to cease cognitive behavioral therapy.
6) Who have repeated anti-social behavior and are anticipated to cease cognitive behavioral therapy.
7) Have significant progressive physical disorder and are anticipated to cease cognitive behavior therapy.
8)Who are difficult to contact with researchers.
9) Others who are regarded inappropriate for carrying the examination safely judged by the responsible doctor or the test sharing psychologist.
10) Who involves litigation or compensation concerning pain symptoms.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Shimizu
Organization Chiba University
Division name Cognitive Behavior Physiology
Zip code
Address Inohana1-8-1 Chuo-ku Chiba-shi Chiba prefecture
TEL 043-226-2028
Email eiji@faculty.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
Zip code
Address Inohana1-8-1 Chuo-ku Chiba-shi Chiba prefecture
TEL 043-226-2028
Homepage URL
Email k.taguchi@chiba-u.jp

Sponsor
Institute Chiba University Hospital
Institute
Department

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
Email

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 12 Month 15 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
2018 Year 11 Month 19 Day
Date of IRB
2018 Year 12 Month 13 Day
Anticipated trial start date
2018 Year 12 Month 25 Day
Last follow-up date
2019 Year 07 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 11 Month 30 Day
Last modified on
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039980

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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