UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033624
Receipt number R000038248
Scientific Title The feasibility study of short-time cognitive behavioral therapy for chronic pain: open label pilot study
Date of disclosure of the study information 2018/08/03
Last modified on 2021/02/03 11:16:34

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The feasibility study of short-time cognitive behavioral therapy for chronic pain: open label pilot study

Acronym

An open label pilot study of the short-time cognitive behavioral therapy for chronic pain

Scientific Title

The feasibility study of short-time cognitive behavioral therapy for chronic pain: open label pilot study

Scientific Title:Acronym

An open label pilot study of the short-time cognitive behavioral therapy for chronic pain

Region

Japan


Condition

Condition

chronic pain

Classification by specialty

Medicine in general Neurology Clinical immunology
Psychosomatic Internal Medicine Psychiatry Orthopedics
Anesthesiology Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the efficacy and feasibility of short-time cognitive behavioral therapy for chronic pain.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

EQ-5D-5L
(Evaluations are performed at baseline and end of the CBT treatment.)

Key secondary outcomes

Numerical Rating Scale
Pain Disability Assessment Scale
Patient Health Questionnaire-9
Pain Catastrophizing Scale
Tampa Scale for Kinesiophobia eleven
Pain Self-Efficacy Questionnaire
Keele STarT Back Screening Tool generic condition
Somatic Symptom Scale-8
Multiple Pain Inventory


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

Short-time CBT for chronic pain (10-15 minutes per session, 8sessions)

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

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1. patients who have the symptoms of chronic pain for at least three months
2. patients who understand the aim and contents of this trial and voluntary give written informed consent

Key exclusion criteria

1. patients who have need medical treatment rapidly
2. patients who have alcohol abuse or drug abuse
3. patients who have mental disease such as hypomania, mania, psychotic disorder
4. patients who have significant suicidal ideation
5. patients who have cognitive dysfunction such as delirium, dementia, mental retardation
6. patients who are difficult to communicate with Japanese
7. patients who have compensation or suits
8. patients who unable to visit a predetermined number of times within the research period
9. patients who are judged inappropriate to the research by the attending physician

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Masaru
Middle name
Last name Horikoshi

Organization

National Center of Neurology and Psychiatry

Division name

National Center for Cognitive Behavior Therapy and Research

Zip code

187-8551

Address

4-1-1 Ogawahigashicho,Kodaira,Tokyo 187-8551 Japan

TEL

042-341-2711

Email

mhorikoshi@ncnp.go.jp


Public contact

Name of contact person

1st name Yuki
Middle name
Last name Oe

Organization

National Center of Neurology and Psychiatry

Division name

National Center for Cognitive Behavior Therapy and Research

Zip code

187-8551

Address

4-1-1 Ogawahigashicho,Kodaira,Tokyo 187-8551 Japan

TEL

042-341-2711

Homepage URL


Email

yukioe@ncnp.go.jp


Sponsor or person

Institute

National Center for Cognitive Behavior Therapy and Research Chronic Pain Study team

Institute

Department

Personal name



Funding Source

Organization

National Center of Neurology and Psychiatry

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

National Center of Neurology and Psychiatry

Address

4-1-1 Ogawahigashicho,Kodaira,Tokyo 187-8551 Japan

Tel

042-341-2711

Email

rinri-jimu@ncnp.go.jp


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 08 Month 03 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

2017 Year 11 Month 24 Day

Date of IRB

2017 Year 11 Month 24 Day

Anticipated trial start date

2018 Year 02 Month 15 Day

Last follow-up date

2019 Year 11 Month 30 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 08 Month 03 Day

Last modified on

2021 Year 02 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038248


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name