UMIN-CTR Clinical Trial

Public title

The efficacy and feasibility study of the Group Cognitive Behavioral Therapy program for Irritable Bowel Syndrome:open label pilot study

Acronym

An open label pilot study of the Group Cognitive Behavioral Therapy for Irritable Bowel Syndrome

Scientific Title

The efficacy and feasibility study of the Group Cognitive Behavioral Therapy program for Irritable Bowel Syndrome:open label pilot study

Scientific Title:Acronym

An open label pilot study of the Group Cognitive Behavioral Therapy for Irritable Bowel Syndrome

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

To examine the efficacy and feasibility of group cognitive behavioral therapy for irritable bowel syndrome

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

1.The Japanese version of the irritable bowel syndrome quality of life instrument(IBS-QOL-J)
2.The Japanese version of the irritable bowel syndrome-severity index(IBSSI-J)

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.Dropout rate
7.Adverse Events

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

NO

Concealment

No need to know

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

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

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

Age-lower limit

16

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Persons diagnosed with irritable bowel syndrome based on the Rome III or Rome IV diagnostic criteria
2.Persons who can understand the purpose and content of this trial and give voluntary written informed consent
3.patients who continue to have moderate or severe symptoms after 3 months of medical management
4.Persons who never took psychological treatment for IBS in the past

Key exclusion criteria

1.Person in whom organic disease is suggested by the presence of warning symptoms**
2.Those who can not understand Japanese
3.Persons suffering from sever anxiety disorders and depression or with suicidal ideation (diagnose by PHQ-9)
4.Any other person whom the principal investigator has determined to be unsuitable as a participant of the study

**Warning symptoms list
1.Symptoms which first appeared after 50 years of age
2.Any rectal bleeding that has not undergone sufficient medical investigation (excluding that caused by known hemorrhoids)
3.Diarrhea predominant IBS in which no colonoscopy investigation has been conducted
4.Unexplained weight loss without a change in eating habits
5.Nocturnal symptoms sufficient to cause insomnia
6.The presence of warning symptoms (anemia, inflammatory reactions or fecal occult blood)
7.A medical history that makes evaluation of this study difficult. (Past and present)
8.Persons with a family history of colon cancer in a first or second degree relative (grandparents, parents, siblings or children)

Target sample size

15

Name of lead principal investigator

1st name
Middle name
Last name	Toshiaki Furukawa

Organization

Graduate school of Medicine and Faculty of Medicine Kyoto University

Division name

Health Promotion and Human Behavior

Zip code

Address

Yoshida Konoe-cho, Sakyo-ku, Kyoto

TEL

075-753-9491

Email

furukawa@kuhp.kyoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shino Kikuchi

Organization

Graduate school of Medicine and Faculty of Medicine Kyoto University

Division name

Health Promotion and Human Behavior

Zip code

Address

Yoshida Konoe-cho, Sakyo-ku, Kyoto

TEL

075-753-9491

Homepage URL

Email

shino_k@kuhp.kyoto-u.co.jp

Institute

Kyoto University

Institute

Department

Personal name

Organization

Ministry of Education Culture SportsScience and Technology Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

National Center for Cognitive Behavior Therapy and Research

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

高槻赤十字病院（大阪府）

Date of disclosure of the study information

2017

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

08

Month

17

Day

Date of IRB

Anticipated trial start date

2017

Year

11

Month

25

Day

Last follow-up date

2018

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

08

Month

17

Day

Last modified on

2018

Year

07

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032075