UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027800
Receipt number R000031855
Scientific Title The examination of the effective Acceptance and Commitment Therapy-based bibliotherapy of Irritable bowel syndrome symptoms for university students.
Date of disclosure of the study information 2017/06/29
Last modified on 2020/12/21 15:17:33

* 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

The examination of the effective Acceptance and Commitment Therapy-based bibliotherapy of Irritable bowel syndrome symptoms for university students.

Acronym

The examination of the effectiveness of ACT-based bibliotherapy of Irritable bowel syndrome

Scientific Title

The examination of the effective Acceptance and Commitment Therapy-based bibliotherapy of Irritable bowel syndrome symptoms for university students.

Scientific Title:Acronym

The examination of the effectiveness of ACT-based bibliotherapy of Irritable bowel syndrome

Region

Japan


Condition

Condition

Irritable bowel syndrome

Classification by specialty

Hepato-biliary-pancreatic medicine Psychosomatic Internal Medicine Psychiatry
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is whether Acceptance and Commitment Therapy-based bibliotherapy for university students who show IBS symptoms could demonstrate significant decrease in irritable bowel syndrome severity score.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The Japanese version of the Irritable bowel syndrome severity index (IBSSI-J)

Key secondary outcomes

1.The Japanese version of the irritable bowel syndrome quality of life instrument (IBS-QOL-J)
2.Medical Outcome Study 36-item Short Form Health Survey (SF-36)
3.Beck Depression Inventory-Second Edition (BDI-2)
4.State Trait Anxiety Inventory (STAI)
5. The Japanese version of the Acceptance and Action Questionnaire-II
6. The Japanese version of the Cognitive Fusion Questionnaire
7. The Japanese version of the Five Facet Mindfulness Questionnaire


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Acceptance and Commitment Therapy based bibliotherapy

Interventions/Control_2

Waiting

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

18 years-old <=

Age-upper limit

50 years-old >

Gender

Male and Female

Key inclusion criteria

1.The score of IBSSI >= 75 at the screening
2.Ability to both understand and agree with informed consent in Japanese

Key exclusion criteria

1.Participants who presently undergoing psychopharmacological, or psychological treatment for gastrointestinal or psychiatric disorder
2.Person in whom organic disease is suggested by the presence of warning symptom (anemia, inflammatory reactions, or fecal occult blood, Unexplained weight loss in past 6 months, Persons with a family history of colon cancer)
3.Persons observed to have significant suicidal ideation
4.Any other person whom the principal investigator has determined to be unsuitable as a participant of the study

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Muto

Organization

Doshisha university

Division name

Faculty of psychology

Zip code


Address

1-3 Miyakodani, Tatara, Kyotanabe, Kyoto

TEL

0774658220

Email

takamuto@mail.doshisha.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masataka Ito

Organization

Doshisha university

Division name

Graduate school of Psychology, Doshisha university

Zip code


Address

1-3 Miyakodani, Tatara, Kyotanabe, Kyoto

TEL

0774658220

Homepage URL


Email

ekq1003@mail2.doshisha.ac.jp


Sponsor or person

Institute

Doshisha university

Institute

Department

Personal name



Funding Source

Organization

Doshisha university

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2017 Year 06 Month 29 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

Terminated

Date of protocol fixation

2017 Year 05 Month 16 Day

Date of IRB

2017 Year 08 Month 10 Day

Anticipated trial start date

2017 Year 10 Month 01 Day

Last follow-up date

2019 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

2017 Year 06 Month 18 Day

Last modified on

2020 Year 12 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031855


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name