NCT01815164

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2013

Completed
Last Updated

March 21, 2013

Status Verified

March 1, 2013

Enrollment Period

4.1 years

First QC Date

March 18, 2013

Last Update Submit

March 20, 2013

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • Irritable Bowel Syndrome Symptom Severity Scale

    3 months

Study Arms (2)

Hypnotherapy

ACTIVE COMPARATOR

Hypnotherapy

Behavioral: Hypnotherapy

Educational intervention

ACTIVE COMPARATOR

Educational intervention

Behavioral: Educational intervention

Interventions

HypnotherapyBEHAVIORAL

Gut-directed hypnotherapy administered by an experienced hypnotherapist.

Hypnotherapy
Educational interventionBEHAVIORAL

Educational intervention vith education regarding Irritabel bowel Syndrome.

Educational intervention

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Linköping, 58185, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 22108191BACKGROUND

  • 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.

    PMID: 23617618DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

HypnosisEarly Intervention, Educational

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and ActivitiesChild Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Susanna Walter, MD, PhD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 18, 2013

First Posted

March 20, 2013

Study Start

August 1, 2007

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

March 21, 2013

Record last verified: 2013-03

Locations

SE(1)