Effect of Hypnotherapy and Educational Intervention in Irritable Bowel Syndrome

NCT ID: NCT01815164

Last Updated: 2013-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2011-09-30

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hypnotherapy

Hypnotherapy

Group Type: ACTIVE_COMPARATOR

Hypnotherapy

Intervention Type: BEHAVIORAL

Gut-directed hypnotherapy administered by an experienced hypnotherapist.

Educational intervention

Educational intervention

Group Type: ACTIVE_COMPARATOR

Educational intervention

Intervention Type: BEHAVIORAL

Educational intervention vith education regarding Irritabel bowel Syndrome.

Interventions

Hypnotherapy

Gut-directed hypnotherapy administered by an experienced hypnotherapist.

Intervention Type: BEHAVIORAL

Educational intervention

Educational intervention vith education regarding Irritabel bowel Syndrome.

Intervention Type: BEHAVIORAL

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

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• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Linkoeping

OTHER

Sponsor Role: lead

Responsible Party

Mats Lowén

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susanna Walter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Linkoeping University

Locations

University Hospital

Linköping, , Sweden

Countries

Sweden

References

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.

Reference Type: BACKGROUND

PMID: 22108191 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23617618 (View on PubMed)

Other Identifiers

M71-09

Identifier Type: -

Identifier Source: org_study_id