Individual vs. Group Hypnotherapy in Patients With Irritable Bowel Syndrome

Not Applicable

Active, not recruiting

• Conditions: IBS - Irritable Bowel Syndrome
• Interventions: Other: Hypnotherapy

• Registration Number: NCT03432078
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief Summary

Patients' fulfilling Rome III criteria for IBS with symptoms refractory to standard treatment who are referred to a specialist unit for hypnotherapy are consecutively included in the study. The patients are randomized to either individual or group treatment given by a nurse trained in hypnotherapy. The treatment consists of eight sessions of gut directed hypno therapy during twelve weeks. Effects are measured by validated questionnaires at baseline and at various time points during the treatment period as well as after the completion of the treatment.

Detailed Description

Patients' fulfilling Rome III criteria for IBS with symptoms refractory to standard treatment who are referred to a specialist unit for hypnotherapy are consecutively included in the study. Firstly, the patients are invited to a meeting with the nurse for information about the study, check for eligibility and to sign the written informed consent. Exclusion criteria that could influence GI symptoms such as organic GI disease, severe psychiatric comorbidity and pregnancy are controlled for. The patients are randomized to either individual or group treatment given by a nurse trained in hypnotherapy and cognitive behavioral therapy. The randomization is organized and performed in blocks by an external unit connected to the University in order to be accurate. The treatment consists of eight sessions of gut directed hypnotherapy during twelve weeks. A standardized protocol is used and is the same both in the group setting as well as in the individual treatment arm. In each group approximately eight patients are included. Every session lasts for one hour. Outcome measures in the study are GI symptom severity, GI-specific anxiety, psychological distress and health related quality of life. These effects are measured by validated questionnaires at baseline and at various time points during the treatment period as well as after the completion of the treatment and during the 6 months-, 1 and 2 year follow-up.

Study Timeline

• Study Start: 2011-08-15
• Study First Submitted: 2018-02-07
• Study First Submitted QC: 2018-02-07
• Study First Posted: 2018-02-13
• Primary Completion: 2019-12-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-07
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

• IBS according to Rome III criteria

Exclusion Criteria

• Organic GI disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individual hypnotherapy	Hypnotherapy	Treatment given on a individual basis, face to face.
Group hypnotherapy	Hypnotherapy	Treatment given in a group setting, face to face.

Primary Outcome Measures

Name	Time	Method
Change of Gastrointestinal symptom severity	Up to ten years	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)

Dept of Internal Medicine, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden