UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043846
Receipt number R000050042
Scientific Title Internet-based Cognitive Behavioral Therapy for Chronic Non-Cancer Pain using Ecological Momentary Assessment
Date of disclosure of the study information 2021/04/07
Last modified on 2022/04/27 11:38:38

* 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

Development of Internet-based Cognitive Behavioral Therapy for Chronic Non-Cancer Pain

Acronym

Internet-based Cognitive Behavioral Therapy for Chronic Non-Cancer Pain

Scientific Title

Internet-based Cognitive Behavioral Therapy for Chronic Non-Cancer Pain using Ecological Momentary Assessment

Scientific Title:Acronym

Internet-based Cognitive Behavioral Therapy for Chronic Non-Cancer Pain

Region

Japan


Condition

Condition

Chronic non-cancer pain

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate the effectiveness of internet-based cognitive behavioral therapy (iCBT) for chronic non-cancer pain. Assessments will include ecological momentary assessment (EMA) in addition to conventional self-report measures of pain and pain-related symptoms. Effects of the iCBT on brain function will also be measured using a functional magnetic resonance imaging (fMRI).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in patient self-reported pain intensity on 11 point (0-10) numerical rating scale (NRS)

Key secondary outcomes

-Changes in psychological state and pain-related physical impairment
-Changes in fMRI
-Changes in EMA


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

Behavior,custom

Interventions/Control_1

-Internet-based cognitive behavioral therapy for chronic pain is a manualized program that consists of 7 weekly or biweekly sessions (maximum of three months).
-Each session will be delivered at our hospital under the guidance of a trained therapist.
-Assessments will include self-report measures, fMRI and EMA that will take place at pre-treatment, post treatment, 6-month follow up and 12-month follow up.

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

1) Chronic non-cancer pain; pain for more than 3 months
2) Unresponsive to conventional medications and nerve blocks (more than 2 months)

Key exclusion criteria

1) Candidate for surgery
2) History of anomalies of the central nervous system
3) Current psychiatric or neurological illness
4) Cognitive impairment

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Shizuko
Middle name
Last name Kosugi

Organization

Keio University School of Medicine

Division name

Department of Anesthesiology

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-5363-3107

Email

kosugi.z6@keio.jp


Public contact

Name of contact person

1st name Kenta
Middle name
Last name Wakaizumi

Organization

Keio University School of Medicine

Division name

Department of Anesthesiology

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan

TEL

03-5363-3107

Homepage URL


Email

kwaka@keio.jp


Sponsor or person

Institute

Keio University

Institute

Department

Personal name



Funding Source

Organization

Keio University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keio University School of Medicine Ethics Committee

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan

Tel

03-3353-1211

Email

med-rinri-jimu@adst.keio.ac.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

2021 Year 04 Month 07 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

Enrolling by invitation

Date of protocol fixation

2021 Year 03 Month 04 Day

Date of IRB

2021 Year 03 Month 30 Day

Anticipated trial start date

2021 Year 05 Month 01 Day

Last follow-up date

2024 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

2021 Year 04 Month 05 Day

Last modified on

2022 Year 04 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050042


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name