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Effect of Hypnotherapy in Irritable Bowel Syndrome (IBS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01279382
First Posted: January 19, 2011
Last Update Posted: January 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Maastricht University Medical Center
  Purpose
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.

Condition Intervention
Irritable Bowel Syndrome Behavioral: Hypnotherapy (HYP) Behavioral: Relaxation training (RT) Other: Care as usual (CON)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiviteit Van Hypnotherapie Bij Prikkelbare Darmsyndroom (Effectiveness of Hypnotherapy in Irritable Bowel Syndrome)

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Mean symptom score (MSS)

Secondary Outcome Measures:
  • Psychological measures, i.e. anxiety and depression (HADS)

Enrollment: 112
Study Start Date: January 2002
Estimated Study Completion Date: January 2006
Arms Assigned Interventions
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
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
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279382


Locations
Netherlands
LUMC - Leiden
Leiden, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Ad Masclee, Prof. Dr. Head of dept
  More Information

Additional Information:
Responsible Party: Prof. Dr. A. Masclee, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01279382     History of Changes
Other Study ID Numbers: P113/99
First Submitted: January 17, 2011
First Posted: January 19, 2011
Last Update Posted: January 19, 2011
Last Verified: January 2011

Keywords provided by Maastricht University Medical Center:
Symptoms
Psychological status
Hypnotherapy
Relaxation training

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases