irritable bowel syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Be at least 18 years of age at the time of consent or registration. (2) Patients must have been diagnosed with IBS at a medical institution by the date of enrollment and have been treated with medication for at least 3 months. (iii) Patients must have residual symptoms of moderate severity (IBS-SSS over 175 points) or higher at the time of enrollment. (4) Meet the diagnostic criteria for IBS of Rome IV. (5) Have regular access to the Internet and be able to participate in online meetings (preferably in an environment that is as quiet and private as possible). (6) Be able to read, write, and communicate in Japanese (7) Understand the purpose and content of this study, and be able to give written consent to participate in the study of their own free will.
Exclusion criteria
Exclusion criteria: (i) At the time of enrolment, those who have received structured psychotherapy for IBS within the last two years, or are receiving it at that time, or plan to receive it during the period of participation. (ii) At the time of enrolment, are currently participating in another IBS clinical trial, or are scheduled to receive such treatment during the period of participation. (iii) Those who are currently undergoing psychiatric or psychosomatic treatment and whose attending physician has judged them to be unsuitable for participation in this study. (iv) Those who are pregnant. (v) Persons who have undergone or are currently undergoing treatment for organic diseases that may cause symptoms such as abdominal pain. (vi) Any other person who is judged to be unsuitable as a subject for this study by the principal investigator or research assistant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the IBS Symptom Severity Score the IBS Quality of Life Measure | — |
Secondary
| Measure | Time frame |
|---|---|
| The visceral sensitivity index The Hospital Anxiety and Depression Scale EuroQol 5 dimensions 5-level Work Productivity and Activity Impairment Questionnaire: General Health Credibility / Expectancy Questionnaire Irritable Bowel Syndrome-Global Improvement Scale Customer Satisfaction Scale-3 adverse event or Serious adverse events | — |
Countries
Japan
Contacts
Nagoya City University Graduate School of Medical Sciences Core Laboratory