Unique ID issued by UMIN | UMIN000035086 |
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Receipt number | 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 | 2020/09/18 17:09:45 |
Effect of Cognitive Behavioral Therapy for chronic pain: Additional Study for the Control Group in the RCT(UMIN000031124)
Cognitive Behavioral Therapy for chronic pain : Additional Study for the Control Group in the RCT(UMIN000031124)
Effect of Cognitive Behavioral Therapy for chronic pain: Additional Study for the Control Group in the RCT(UMIN000031124)
Cognitive Behavioral Therapy for chronic pain : Additional Study for the Control Group in the RCT(UMIN000031124)
Japan |
Somatic symptom disorder (mainly pain)
Psychiatry |
Others
NO
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 .
Others
Can get more information to prove the evidence, by the increase of the patient taking part in the clinical study.
Exploratory
Phase II
Numerical Rating Scale(NRS)
(1week, 8week, 16week)
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
Cognitive behavior therapy(16 weeks)
18 | years-old | <= |
75 | years-old | >= |
Male and Female
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).
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.
20
1st name | |
Middle name | |
Last name | Eiji Shimizu |
Chiba University
Cognitive Behavior Physiology
Inohana1-8-1 Chuo-ku Chiba-shi Chiba prefecture
043-226-2028
eiji@faculty.chiba-u.jp
1st name | |
Middle name | |
Last name | Kayoko Taguchi |
Chiba University
Cognitive Behavior Physiology
Inohana1-8-1 Chuo-ku Chiba-shi Chiba prefecture
043-226-2028
k.taguchi@chiba-u.jp
Chiba University Hospital
Ministry of Health, Labor and Welfare Scientific Research Expenses
Japanese Governmental office
NO
2018 | Year | 12 | Month | 15 | Day |
Unpublished
Completed
2018 | Year | 11 | Month | 19 | Day |
2018 | Year | 12 | Month | 13 | Day |
2018 | Year | 12 | Month | 25 | Day |
2019 | Year | 07 | Month | 31 | Day |
2018 | Year | 11 | Month | 30 | Day |
2020 | Year | 09 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039980
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