ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Hypnotherapy in Irritable Bowel Syndrome (IBS)

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.
ClinicalTrials.gov Identifier: NCT01279382
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : January 19, 2011
Sponsor:
Information provided by:
Maastricht University Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Irritable Bowel Syndrome Behavioral: Hypnotherapy (HYP) Behavioral: Relaxation training (RT) Other: Care as usual (CON) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
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)
Study Start Date : January 2002
Study Completion Date : January 2006

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Mean symptom score (MSS)

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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 Posted: January 19, 2011    Key Record Dates
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