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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028702

Enrollment

Registered

2017-10-01

Start date

2017-11-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable bowel syndrome

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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)	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactShino Kikuchi

Graduate school of Medicine and Faculty of Medicine Kyoto University Health Promotion and Human Behavior

shino_k@kuhp.kyoto-u.co.jp075-753-9491

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026