Back to resultsEffect of Hypnotherapy in Irritable Bowel Syndrome (IBS)
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Hypnotherapy (HYP)
Relaxation training (RT)
Care as usual (CON)
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Symptoms, Psychological status, Hypnotherapy, Relaxation training
Eligibility 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
Sites / Locations
- LUMC - Leiden
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Care as usual (CON)
Hypnotherapy (HYP)
Relaxation training (RT)
Arm Description
CON was given to a subgroup of patients as control treatment in IBS treatment
HYP was given to a subgroup of patients as intervention in IBS treatment
RT was given to a subgroup of patients as intervention in IBS treatment
Outcomes
Primary Outcome Measures
Mean symptom score (MSS)
Secondary Outcome Measures
Psychological measures, i.e. anxiety and depression (HADS)
Full Information
NCT ID
NCT01279382
First Posted
January 17, 2011
Last Updated
January 18, 2011
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01279382
Brief Title
Effect of Hypnotherapy in Irritable Bowel Syndrome (IBS)
Official Title
Effectiviteit Van Hypnotherapie Bij Prikkelbare Darmsyndroom (Effectiveness of Hypnotherapy in Irritable Bowel Syndrome)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Symptoms, Psychological status, Hypnotherapy, Relaxation training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Care as usual (CON)
Arm Type
Other
Arm Description
CON was given to a subgroup of patients as control treatment in IBS treatment
Arm Title
Hypnotherapy (HYP)
Arm Type
Other
Arm Description
HYP was given to a subgroup of patients as intervention in IBS treatment
Arm Title
Relaxation training (RT)
Arm Type
Other
Arm Description
RT was given to a subgroup of patients as intervention in IBS treatment
Intervention Type
Behavioral
Intervention Name(s)
Hypnotherapy (HYP)
Intervention Description
Hypnotherapy was given to a subgroup of patients as intervention in IBS treatment
Intervention Type
Behavioral
Intervention Name(s)
Relaxation training (RT)
Intervention Description
RT was given to a subgroup of patients as intervention in IBS treatment
Intervention Type
Other
Intervention Name(s)
Care as usual (CON)
Intervention Description
CON was given to a subgroup of patients as control intervention in IBS treatment
Primary Outcome Measure Information:
Title
Mean symptom score (MSS)
Secondary Outcome Measure Information:
Title
Psychological measures, i.e. anxiety and depression (HADS)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ad Masclee, Prof. Dr.
Organizational Affiliation
Head of dept
Official's Role
Principal Investigator
Facility Information:
Facility Name
LUMC - Leiden
City
Leiden
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Effect of Hypnotherapy in Irritable Bowel Syndrome (IBS)
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