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NCT06297785 Clinical Trial

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

IBS - Irritable Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06297785
Other study ID # 2022-03997-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 17, 2022
Est. completion date April 2027

Study information
Verified date May 2024
Source Sahlgrenska University Hospital, Sweden
Contact Jenny Lövdahl, Reg. Nurse, hypnotherapist
Phone 0313428107
Email magtarmlab.su@vgregion.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date April 2027
Est. primary completion date April 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - IBS diagnosis Exclusion Criteria: - Organic GI disease

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Gut-directed hypnotherapy
Gut-directed hypnotherapy for patients with irritable bowel syndrome (IBS). Gut-directed hypnotherapy (8 sessions), will be given online in a group setting.The hypnosis treatment is administered by a nurse specially trained in Cognitive Behavioral Therapy (CBT) and hypnotherapy. The treatment is based on the North Carolina protocol. Patients will assess gastro-intestinal symptom severity before, during and after treatment, as well as at follow-up.

Locations
Country Name City State
Sweden Mag-Tarmlab, Sahlgrenska University Hospital Gothenburg
Sweden Sahlgrenska University Hospital Gothenburg

Sponsors (1)
Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in gastrointestinal symptom severity measured by the IBS Severity Scoring System questionnaire (IBS-SSS) 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. Baseline (week 0), during treatment (week 6), at treatment completion (week 12), follow-up (6 months, 1 and 2 years after treatment initiation)
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