Effect of Hypnotherapy in Irritable Bowel Syndrome (IBS)

January 18, 2011 updated by: Maastricht University Medical Center

Effectiviteit Van Hypnotherapie Bij Prikkelbare Darmsyndroom (Effectiveness of Hypnotherapy in Irritable Bowel Syndrome)

In this trial, the effects of two psychological interventions - i.e. hypnotherapy and relaxation training - are compared with care as usual in IBS treatment. The investigators hypothesized that hypnotherapy is most effective in reducing complaints in IBS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Irritable bowel syndrome (Rome II)
  • Presence of complaints < 12 months

Exclusion Criteria:

  • Gastrointestinal disorders, other than IBS
  • Previous psychotherapeutic treatment for IBS
  • Severe psychological comorbidity

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Care as usual (CON)
CON was given to a subgroup of patients as control treatment in IBS treatment
Other: Care as usual (CON)
CON was given to a subgroup of patients as control intervention in IBS treatment
Other: Hypnotherapy (HYP)
HYP was given to a subgroup of patients as intervention in IBS treatment
Behavioral: Hypnotherapy (HYP)
Hypnotherapy was given to a subgroup of patients as intervention in IBS treatment
Other: Relaxation training (RT)
RT was given to a subgroup of patients as intervention in IBS treatment
Behavioral: Relaxation training (RT)
RT was given to a subgroup of patients as intervention in IBS treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mean symptom score (MSS)

Secondary Outcome Measures

Outcome Measure
Psychological measures, i.e. anxiety and depression (HADS)

Collaborators and Investigators

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

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Ad Masclee, Prof. Dr., Head of dept

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

January 1, 2002

Study Completion

January 1, 2006

Study Registration Dates

First Submitted

January 17, 2011

First Submitted That Met QC Criteria

January 18, 2011

First Posted (Estimate)

January 19, 2011

Study Record Updates

Last Update Posted (Estimate)

January 19, 2011

Last Update Submitted That Met QC Criteria

January 18, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P113/99

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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