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

December 11, 2023 updated by: Magnus Simrén, Sahlgrenska University Hospital, Sweden
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Magnus Simrén

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Adult IBS patients with symptoms refractory to standard treatment.

Description

Inclusion Criteria: IBS diagnosis. -

Exclusion Criteria: Organic GI disease.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Nurse-delivered, 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.
Behavioral: Gut-directed hypnotherapy
Gut-directed hypnotherapy for patients with irritable bowel syndrome (IBS). Gut-directed hypnotherapy (8-12 sessions), were given either in an individual manner or in a group setting.The hypnosis treatment is administered by two nurses specially trained in Cognitive Behavioral Therapy (CBT) and hypnotherapy. The treatment was based on the North Carolina protocol. Patients assessed gastro-intestinal symptom severity before, during and after treatment, as well as at follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in gastrointestinal symptom severity
Time Frame: 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.
Baseline (week 0), during treatment (week 6), at treatment completion (week 8), follow-up (6 months, 1 and 2 years after treatment initiation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Investigators

  • Principal Investigator: Magnus Simrén, Prof, Göteborg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2005

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

December 1, 2023

First Submitted That Met QC Criteria

December 11, 2023

First Posted (Actual)

December 12, 2023

Study Record Updates

Last Update Posted (Actual)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 636-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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