Online, Gut-directed Hypnotherapy for Patients With Irritable Bowel Syndrome (IBS)

Not Applicable

Recruiting

• Conditions: IBS - Irritable Bowel Syndrome

• Registration Number: NCT06297785
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief Summary

Adult IBS patients with symptoms refractory to standard medical treatment will receive online nurse-administered, gut-directed hypnotherapy in groups. The primary outcome measure was change in gastro-intestinal symptom severity.

Detailed Description

IBS patients with symptoms refractory to standard treatment and who were referred to a specialist unit for hypnotherapy, will be included in the study consecutively. The patients will receive gut-directed hypnotherapy given by a nurse trained in Cognitive Behavioral Therapy (CBT) and hypnotherapy. Effects of treatment will be measured by validated questionnaires at baseline and at various time points during the treatment period, as well as after the completion of the treatment at follow-up 6 months, 1 and 2 years after treatment.

Study Timeline

• Study Start: 2022-10-17
• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-01
• Study First Posted: 2024-03-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• IBS diagnosis

Exclusion Criteria

• Organic GI disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in gastrointestinal symptom severity measured by the IBS Severity Scoring System questionnaire (IBS-SSS)	Baseline (week 0), during treatment (week 6), at treatment completion (week 12), follow-up (6 months, 1 and 2 years after treatment initiation)	The score is calculated from 5 items: pain severity, pain frequency, abdominal bloating severity, bowel habit dissatisfaction and daily life interference. The score ranges from 0-500. A higher the score signifies more severe symptoms. A symptom score reduction of 50 points or more after treatment compared to the baseline score is considered a response to treatment.

Trial Locations

Locations (2)

Mag-Tarmlab, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden