UMIN-CTR Clinical Trial

Public title

Effectiveness and feasibility study of the cognitive behavioral therapy program for irritable bowel syndrome

Acronym

An open label pilot study of the cognitive behavioral therapy for irritable bowel syndrome

Scientific Title

Effectiveness and feasibility study of the cognitive behavioral therapy program for irritable bowel syndrome

Scientific Title:Acronym

An open label pilot study of the 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 feasibility and effectiveness of cognitive behavioral therapy for irritable bowel syndrome in Japan.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1. The Japanese version of the irritable bowel syndrome-severity index (IBSSI-J)
2. Visceral sensitivity index (VSI)

Key secondary outcomes

1. IBS-Global Improvement Scale (IBS-GIS)
2. The Japanese version of the irritable bowel syndrome quality of life instrument (IBS-QOL-J)
3. Medical Outcome Study 36-item Short Form Health Survey (SF-36)
4. Beck Depression Inventory-Second Edition (BDI-2)
5. State Trait Anxiety Inventory (STAI)
6. Overall Anxiety Severity and Impairment Scale (OASIS)
7. Overall Depression Severity and Impairment Scale (ODSIS)
8. EuroQol (EQ5D)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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, 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

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Persons diagnosed with irritable bowel syndrome based on the Rome III diagnostic criteria2. Those whose severity is moderate or severe (IBSSI-J score => 175)
3. Persons who can understand the purpose and content of this trial and give voluntary written informed consent.

Key exclusion criteria

1. Person in whom organic disease is suggested by the presence of warning symptoms*.
2. Persons with a history of or concomitant inflammatory bowel disease, malignant tumor, or other bowel disease which could cause the current bowel symptoms.
3. Persons suffering from major psychiatric disease, such as psychotic disorders, bipolar disorder, substance abuse-related disorders, or eating disorders (persons with anxiety disorders and depression without suicidal ideation are not excluded)
4. Persons with antisocial personality disorders.
5. Persons observed to have significant suicidal ideation at screening.
6. Persons with another past or present psychiatric or physical disease that is likely to interfere with continuation and evaluation of the study.
7. Persons experiencing any other type of marked chronic pain.
8. Those taking narcotic analgesics.
9. Persons who anticipate difficulty attending 10 sessions as an outpatient during the 16-week CBT implementation period.
10. Those who have previously received structured individual CBT.
11. Those for whom verbal and written communication in Japanese is not possible
12. Pregnant or lactating women.
13. 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. Persons with a family history of colon cancer in a first- or second-degree relative (grandparents, parents, siblings, or children).

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Tetsuya Ando

Organization

National Center of Neurology and Psychiatry

Division name

Department of Psychosomatic Research, National Institute of Mental Health

Zip code

Address

4-1-1 Ogawahigashi Kodaira, Tokyo 187-8553, Japan

TEL

042-341-2711

Email

ando-t@ncnp.go.jp

Name of contact person

1st name
Middle name
Last name	Tetsuya Ando

Organization

National Center of Neurology and Psychiatry

Division name

Department of Psychosomatic Research, National Institute of Mental Health

Zip code

Address

4-1-1 Ogawahigashi Kodaira, Tokyo 187-8553, Japan

TEL

042-341-2711

Homepage URL

Email

ando-t@ncnp.go.jp

Institute

National Center of Neurology and Psychiatry

Institute

Department

Personal name

Organization

National Center of Neurology and Psychiatry

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

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

Date of disclosure of the study information

2013

Year

03

Month

19

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

No longer recruiting

Date of protocol fixation

2013

Year

03

Month

15

Day

Date of IRB

Anticipated trial start date

2013

Year

03

Month

19

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

03

Month

12

Day

Last modified on

2017

Year

06

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011972