UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030620
Receipt number R000034965
Scientific Title A randomized controlled trial of cognitive behavioral therapy for irritable bowel syndrome using complementary psychoeducational video
Date of disclosure of the study information 2017/12/28
Last modified on 2019/06/05 11:27:59

* 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

A randomized controlled trial of cognitive behavioral therapy for irritable bowel syndrome using complementary psychoeducational video

Acronym

A randomized controlled trial of the cognitive behavioral therapy for irritable bowel syndrome

Scientific Title

A randomized controlled trial of cognitive behavioral therapy for irritable bowel syndrome using complementary psychoeducational video

Scientific Title:Acronym

A randomized controlled trial of the cognitive behavioral therapy for irritable bowel syndrome

Region

Japan


Condition

Condition

Irritable bowel syndrome

Classification by specialty

Medicine in general Gastroenterology Psychosomatic Internal Medicine
Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine effectiveness of cognitive behavioral therapy compared with treatment as usual only(TAU alone) for irritable bowel syndrome in Japan.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

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

Key secondary outcomes

1.Visceral sensitivity index(VSI)
2.IBS-Global Improvement Scale(IBS-GIS)
3.The Japanese version of the irritable bowel syndrome quality of life instrument(IBS-QOL-J)
4.Medical Outcome Study 36-item Short Form Health Survey (SF-36)
5.Beck Depression Inventory-Second Edition (BDI-2)
6.State Trait Anxiety Inventory(STAI)
7.IBS Diary
8.Body Vigilance Scale(BVS)
9.Cognitive control scale
10.Patient characteristics information


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Cognitive Behavioral Therapy for irritable bowel syndrome (Once a week, 10 sessions) and treatment as usual(TAU) including drug therapy and lifestyle advice.

Interventions/Control_2

Treatment as usual (TAU) for Irritable bowel syndrome including drug therapy and lifestyle advice.

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

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 4 diagnostic criteria
2.Those whose severity is moderate or severe(IBSSI-J score =>175 and over)
3.Persons who can understand the purpose and contents of this trial and give voluntary written an 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, eating disorders, obsessive and compulsive disorders,or PTSD (persons with anxiety disorders, somatic symptom and related 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

120


Research contact person

Name of lead principal investigator

1st name Tetsuya
Middle name
Last name Ando

Organization

National Center of Neurology and Psychiatry

Division name

Department of Behavioral Medicine, National Institute of Mental Health

Zip code

187-8553

Address

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

TEL

042-341-2711

Email

ando-t@ncnp.go.jp


Public contact

Name of contact person

1st name Hitomi
Middle name
Last name Kawanishi

Organization

National Center of Neurology and Psychiatry

Division name

Department of Behavioral Medicine, National Institute of Mental Health

Zip code

187-8553

Address

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

TEL

042-341-2711

Homepage URL


Email

hitomi_K@ncnp.go.jp


Sponsor or person

Institute

National Center of Neurology and Psychiatry

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

Tohoku University, University of Tokyo, National Center for Global Health and Medicine, Konodai Hospital National Center for Global Health and Medicine

Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Center of Neurology and Psychiatry

Address

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

Tel

+81423412711

Email

ml_rinrijimu@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

東北大学(宮城県)、東京大学(東京都)、国立国際医療研究センター病院(東京都)、国立国際医療研究センター国府台病院(千葉県)/Tohoku University, University of Tokyo, National Center for Global Health and Medicine, Konodai Hospital National Center for Global Health and Medicine


Other administrative information

Date of disclosure of the study information

2017 Year 12 Month 28 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

Open public recruiting

Date of protocol fixation

2017 Year 11 Month 29 Day

Date of IRB

2018 Year 04 Month 17 Day

Anticipated trial start date

2019 Year 02 Month 07 Day

Last follow-up date

2021 Year 10 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

2017 Year 12 Month 28 Day

Last modified on

2019 Year 06 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034965


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name