Effect of Hypnotherapy in Irritable Bowel Syndrome (IBS)

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01279382
First received: January 17, 2011
Last updated: January 18, 2011
Last verified: January 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Prof. Dr. A. Masclee, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01279382     History of Changes
Other Study ID Numbers: P113/99
Study First Received: January 17, 2011
Last Updated: January 18, 2011
Health Authority: The Netherlands: Commissie Medische Ethiek (CME), Leiden

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

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

ClinicalTrials.gov processed this record on September 22, 2014