UMIN-CTR Clinical Trial

Public title

The Efficacy of Group Cognitive Behavior
Therapy for Irritable Bowel Syndrome:
Randomized Controlled Trial

Acronym

Successful Use of CBT for IRrItable bowel syndrome (SUCIRI) project

Scientific Title

The Efficacy of Group Cognitive Behavior
Therapy for Irritable Bowel Syndrome:
Randomized Controlled Trial

Scientific Title:Acronym

Successful Use of CBT for IRrItable bowel syndrome (SUCIRI) project

Region

Japan

Condition

irritable bowel syndrome

Classification by specialty

Medicine in general	Gastroenterology	Psychosomatic Internal Medicine
Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Assessing efficacy and safety of group cognitive behavioral therapy for irritable bowel syndrome (at 13 week from the start of the study)

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1.the IBS Symptom Severity Score (IBS-SSS)
2.the IBS-Quality of Life Measure (IBS-QOL)

Key secondary outcomes

1.Irritable Bowel Syndrome-Global Improvement Scale(Japanese:IBS-GIS)
2.EuroQol-5D-5L(Japanese:EQ-5D-5L)
3.Patient Health Questionnaire-9(Japanese:PHQ-9)
4.Generalized Anxiety Disorder-7(Japanese:GAD-7)
5.Gastrointestinal Symptom Rating Scale(Japanese:GSRS)
6.The Composite Primary Symptom Reduction(CPSR)
7.Dropout rate
8.Adverse Events

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Group Cognitive Behavioral Therapy for Irritable Bowel Syndrome (Once a week,90 minutes session,10 sessions)

Interventions/Control_2

waiting list

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1.People diagnosed by gastroenterologist and have have moderate or severe symptoms remaining after receiving symptom-targeted pharmacotherapy for 3 months or more.
2.People diagnosed with irritable bowel syndrome based on the Rome III or Rome IV diagnostic criteria
3.People who basically do not change (as much as possible) usual treatment for IBS during the research
4.People who are capable of continuous hospital visits and motivated
5.People who can communicate, read and write in Japanese
6.Persons who can understand the purpose and content of this trial and give voluntary written informed consent

Key exclusion criteria

1.People who has received psychotherapies
2.People who are currently undergoing treatment in psychiatry or psychosomatic department and judged that psychiatry or psychosomatic medicine doctor is inappropriate for participation in this study
3.People who are suffering from sever anxiety disorders and depression or with suicidal attempt (using PHQ-9)
4.Pregnant women
5.People who is treated or under treatment due to organic disease of the abdomen
6.People whom the principal investigator has determined to be unsuitable as a participant of the study

Target sample size

112

Name of lead principal investigator

1st name	Toshiaki
Middle name
Last name	Furukawa

Organization

Graduate school of Medicine and Faculty of Medicine Kyoto University

Division name

Health Promotion and Human Behavior

Zip code

60608501

Address

Yoshida Konoe-cho, Sakyo-ku, Kyoto

TEL

075-753-9491

Email

furukawa@kuhp.kyoto-u.ac.jp

Name of contact person

1st name	Shino
Middle name
Last name	Kikuchi

Organization

Graduate school of Medicine and Faculty of Medicine Kyoto University

Division name

Health Promotion and Human Behavior

Zip code

60608501

Address

Yoshida Konoe-cho, Sakyo-ku, Kyoto

TEL

090-8377-8549

Homepage URL

https://suciri.localinfo.jp/

Email

suciri117@gmail.com

Institute

Kyoto University

Institute

Department

Personal name

Organization

Other

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

National Center for Cognitive Behavior Therapy and Research

Name of secondary funder(s)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

京都大学医学部付属病院（京都府）

Date of disclosure of the study information

2018

Year

04

Month

06

Day

URL releasing protocol

https://bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-020-1157-z

Publication of results

Published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/35103022/

Number of participants that the trial has enrolled

114

Results

At week 13, the IBS-SSS was 86.1 points lower (95% CI 55.0-117.3), and the IBS-QOL was 20.3 points higher (15.2-25.3) in the GCBT-IE arm than in the WL arm. The GCBT-IE arm also had 1.9 times (95% CI 1.3-2.7) more IBS-SSS responders (50 points reduction) and 7.6 times (3.2-17.9) more IBS-QOL responders (14 points increase) than the WL arm. In the GCBT-IE arm, greater improvement in both IBS symptom severity and QoL was maintained at week 27.

Results date posted

2022

Year

05

Month

08

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2022

Year

04

Month

01

Day

Baseline Characteristics

In the current sample of participants, 83.3% met both Rome III and IV criteria, whereas 16.7% met only Rome III criteria. Baseline characteristics were balanced between the 2 arms. After randomization, 5 of54 participants (9.3%) in the GCBTIE arm and 2(3.3%)in the WL arm withdrew from the study by week 13. For adherence, all participants in the GCBT-IE arm received their first session, and 52(96.3%)completed at least the first 5 sessions (per-protocol set). In the GCBT-IE arm, 48/54(88.9%)participants completed the week 27 follow-up assessment by July 2021.

Participant flow

Between May2018 and December 2020, 266 people were referred to our study, including self-referrals, and after eligibility screening, 114 were randomly assigned 54 to GCBT-IE or 60 to WL.

Adverse events

Five participants reported 6 unexpected SAEs (5 in the GCBTIE arm and 1 in the WL arm). All events were reported to the medical ethics committee and were determined to be unrelated to the intervention. Another 17 AEs were reported (7 in the GCBTIE arm and 10 in the WL arm). Because of AEs or SAEs, 4/54 (7.4%) participants in the GCBT-IE arm (cardiac death, depression, neurological disorder, and fracture) and 2/60 (3.3%) in the WL arm (panic disorder and gastrointestinal disorder) dropped out.

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2018

Year

03

Month

13

Day

Date of IRB

2018

Year

03

Month

13

Day

Anticipated trial start date

2018

Year

05

Month

22

Day

Last follow-up date

2021

Year

07

Month

25

Day

Date of closure to data entry

Date trial data considered complete

2021

Year

07

Month

25

Day

Date analysis concluded

2021

Year

09

Month

20

Day

Other related information

Registered date

2018

Year

03

Month

13

Day

Last modified on

2022

Year

05

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035391