UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035086
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

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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 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


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

Completed

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

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=R000039980


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name