Nurse-administered, Gut-directed Hypnotherapy for Patients With Irritable Bowel Syndrome (IBS).

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Behavioral: Gut-directed hypnotherapy

• Registration Number: NCT06167018
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief Summary

Adult IBS patients with symptoms refractory to standard medical treatment received nurse-administered, gut-directed hypnotherapy. 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, were consecutively included in the study. The patients received gut-directed hypnotherapy given by a nurse trained in Cognitive Behavioral Therapy (CBT) and hypnotherapy. Between 2005 and 2015 patients received 8-12 sessions in an individual manner for 12 weeks. From 2016 the treatment was given in a group format. Effects of treatment were 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: 2005-09
• Primary Completion: 2023-06
• Status Verified: 2023-12
• Study Completion: 2023-12
• Study First Submitted: 2023-12-01
• Study First Submitted QC: 2023-12-11
• Last Update Submitted: 2023-12-11
• Study First Posted: 2023-12-12
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

IBS diagnosis. -

Exclusion Criteria

Organic GI disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nurse-delivered, gut-directed hypnotherapy	Gut-directed hypnotherapy	Adult patients suffering from irritable bowel syndrome (IBS), with symptoms refractory to standard treatment. Patients referred to a tertiary care center were included.

Primary Outcome Measures

Name	Time	Method
Change in gastrointestinal symptom severity	Baseline (week 0), during treatment (week 6), at treatment completion (week 8), follow-up (6 months, 1 and 2 years after treatment initiation)	Measured with Irritable Bowel Syndrome- severity scoring system (IBS-SSS). The questionnaire measures severity of GI symptoms and consists of five questions where each score ranges from 0 to 100. A total score of all five questions is calculated ranging from 0 to 500. The higher the score the more severe the GI symptoms.

Trial Locations

Locations (1)

Magnus Simrén; 🇸🇪 Gothenburg, Sweden