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Effect of Hypnotherapy and Educational Intervention in Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Hypnotherapy
Educational intervention
Sponsored by
University Hospital, Linkoeping
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Rome III Female Age 20-60 Swedish speaking Right-handed

Exclusion Criteria:

Central acting medication IBD Psychiatric diseases Abdominal surgery NictoinePacemaker Prosthesis Metal in the brain Claustrophobia Large tattoo

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Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Hypnotherapy

Educational intervention

Arm Description

Hypnotherapy

Educational intervention

Outcomes

Primary Outcome Measures

Irritable Bowel Syndrome Symptom Severity Scale

Secondary Outcome Measures

Full Information

First Posted
March 18, 2013
Last Updated
March 20, 2013
Sponsor
University Hospital, Linkoeping
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1. Study Identification

Unique Protocol Identification Number
NCT01815164
Brief Title
Effect of Hypnotherapy and Educational Intervention in Irritable Bowel Syndrome
Official Title
Effect of Hypnotherapy and Educational Intervention on Brain Response to Visceral Stimulus Perception in the Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Linkoeping

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Aim: Gut directed hypnotherapy can reduce IBS symptoms but the mechanisms underlying this therapeutic effect remain unknown. We determined the effect of hypnotherapy and educational intervention on brain responses to cued rectal distensions in IBS patients. Methods: 44 women with moderate to severe IBS and 20 healthy controls (HCs) were included.. Blood oxygen level dependent (BOLD) signals were measured by functional Magnetic Resonance Imaging (fMRI) during expectation and delivery of high (45 mmHg) and low (15 mmHg) intensity rectal distensions. Twenty-five patients were assigned to hypnotherapy (HYP) and 16 to educational intervention (EDU). 31 patients completed the treatments and the post treatment fMRI. Results: Similar symptom reduction was achieved in both groups. HYP responders demonstrated a pre-post treatment BOLD attenuation in both anterior and posterior insula during high intensity distension, while EDU responders had a BOLD attenuation in prefrontal cortex. Pre-post differences for the low distension and for the two expectation conditions were almost exclusively seen in the HYP group. For all responders there was a significant correlation between treatment induced reduction of GI related anxiety and BOLD decrease in the anterior insula. Following treatment, the brain response to distension was similar to that observed in HCs, suggesting that the treatment had a normalizing effect on the central processing abnormality of visceral signals in IBS. Conclusions: The abnormal processing and enhanced perception of visceral stimuli in IBS can be normalized by psychological interventions. Symptom improvement in the treatment groups may be mediated by different brain mechanisms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypnotherapy
Arm Type
Active Comparator
Arm Description
Hypnotherapy
Arm Title
Educational intervention
Arm Type
Active Comparator
Arm Description
Educational intervention
Intervention Type
Behavioral
Intervention Name(s)
Hypnotherapy
Intervention Description
Gut-directed hypnotherapy administered by an experienced hypnotherapist.
Intervention Type
Behavioral
Intervention Name(s)
Educational intervention
Intervention Description
Educational intervention vith education regarding Irritabel bowel Syndrome.
Primary Outcome Measure Information:
Title
Irritable Bowel Syndrome Symptom Severity Scale
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Rome III Female Age 20-60 Swedish speaking Right-handed Exclusion Criteria: Central acting medication IBD Psychiatric diseases Abdominal surgery NictoinePacemaker Prosthesis Metal in the brain Claustrophobia Large tattoo -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanna Walter, MD, PhD
Organizational Affiliation
Linkoeping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Linköping
ZIP/Postal Code
58185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
22108191
Citation
Larsson MB, Tillisch K, Craig AD, Engstrom M, Labus J, Naliboff B, Lundberg P, Strom M, Mayer EA, Walter SA. Brain responses to visceral stimuli reflect visceral sensitivity thresholds in patients with irritable bowel syndrome. Gastroenterology. 2012 Mar;142(3):463-472.e3. doi: 10.1053/j.gastro.2011.11.022. Epub 2011 Nov 19.
Results Reference
background
PubMed Identifier
23617618
Citation
Lowen MB, Mayer EA, Sjoberg M, Tillisch K, Naliboff B, Labus J, Lundberg P, Strom M, Engstrom M, Walter SA. Effect of hypnotherapy and educational intervention on brain response to visceral stimulus in the irritable bowel syndrome. Aliment Pharmacol Ther. 2013 Jun;37(12):1184-97. doi: 10.1111/apt.12319. Epub 2013 Apr 25.
Results Reference
derived

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Effect of Hypnotherapy and Educational Intervention in Irritable Bowel Syndrome

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