Resilience in Irritable Bowel Syndrome and Gut-focused Hypnotherapy

NCT ID: NCT02737410

Last Updated: 2016-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-10-31

Brief Summary

Background:

Resilience refers to a class of variables highly relevant for wellbeing and coping with stress, trauma, and chronic adversity. Despite its significance for health, resilience is hardly examined empirically and suffers from poor conceptual integration. Irritable bowel syndrome (IBS) is a functional disorder with altered psychological stress reactivity and brain-gut-microbiota axis, which causes high chronic strain. Gut-focused hypnotherapy (GHT) is a standardized treatment for IBS targeting at resilience. An increase of resilience by GHT has been hypothesized but requires further investigation.

Aims of the study were construct validation and development of an integrational measure of different resilience domains by dimensional reduction, and investigation of change in resilience in IBS patients by GHT.

N=74 Gastroenterology outpatients with Irritable Bowel Syndrome (Rome III criteria) were examined in 7 resilience domains, quality of life, psychological distress and symptom severity. n=53 of these participate in 7 to 10 Gut-directed Hypnotherapy group sessions (Manchester protocol). Post-treatment examinations were performed 10 months after last GHT session.

Detailed Description

Aims of this study were, to measure detailed factors of resilience by adequate psychological instruments in a sample of Irritable Bowel Syndrome (IBS) patients and to investigate whether they are facets of the same underlying construct. To calculate a composite measure of resilience based on obtained insights concerning the structure of resilience. To test the hypothesis of a positive relation between resilience and response to therapy. And finally, to investigate differences between patients untreated or treated with Gut-directed Hypnotherapy in groups cross-sectionally and longitudinally, to test the hypothesis of a presumed increase in resilience (using the composite score) with changes in IBS symptoms, quality of life and psychological distress in parallel.

Study location and recruitment:

N=74 Irritable bowel syndrome patients (diagnosed according to Rome III criteria) aged between 18 and 70 and refractory to other therapies were recruited at the Specialized outpatient-clinic for Psychosomatics at the Division of Gastroenterology and Hepatology, Department for Internal Medicine III, University Hospital of Vienna. Antidepressants or anxiolytics and/or ongoing psychotherapy were allowed since severe comorbid psychological problems are a common problem in IBS patients. The study protocol was approved by the ethics committee of the Medical University of Vienna (ID: 1488/2012). Informed consent in writing was given by each participant.

Study Design and Treatment:

Cross-sectional comparisons were performed with data of n = 37 GHT treated and n = 37 untreated patients (control group) post GHT. This data were pooled for dimensional reduction of resilience domains. Resilience and IBS severity data from the treatment group were assessed post GHT; psychological distress and quality of life were assessed pre and post GHT. A fraction of n = 16 of the untreated patients (former control group) subsequently also received GHT treatment. Pre and post GHT data of these patients were collected and then used for longitudinal comparisons, along with the pre and post GHT data on psychological distress and quality of life of the primary treatment group. In total, N= 74 patients were examined, in total 53 (= 37 + 16) of which underwent GHT. Post treatment examinations were performed 10 months after last GHT session. The GHT protocol used was the Manchester protocol of GHT and consisted of 10 weekly sessions (45 min), with six patients per group over a treatment period of 12 weeks. GHT was performed at the University Hospital by two experienced physicians trained in Manchester (UK).

Conditions

Irritable Bowel Syndrome

Study Design

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

Study Groups

Treatment

Treatment group obtaining Gut-directed Hypnotherapy

Group Type: ACTIVE_COMPARATOR

Gut-directed Hypnotherapy

Intervention Type: BEHAVIORAL

The GHT protocol used was the Manchester protocol of GHT and consisted of 10 weekly sessions (45 min), with six patients per group over a treatment period of 12 weeks. GHT was performed at the University Hospital by two experienced physicians trained in Manchester (UK).

Control

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Gut-directed Hypnotherapy

The GHT protocol used was the Manchester protocol of GHT and consisted of 10 weekly sessions (45 min), with six patients per group over a treatment period of 12 weeks. GHT was performed at the University Hospital by two experienced physicians trained in Manchester (UK).

Intervention Type: BEHAVIORAL

Other Intervention Names

Gut-focused Hypnotherapy

Eligibility Criteria

Inclusion Criteria

• a diagnosis of IBS (Rome-III-criteria)
• Indication of GHT because of no adequate relief of IBS symptoms and no improvement of disease-related quality of life through other IBS therapies

Exclusion Criteria

• pregnancy, mental retardation
• insufficient knowledge of German
• transit time from home to hospital longer than one hour

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Gabriele Moser

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gabriele Moser, Professor

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

1488/2012

Identifier Type: -

Identifier Source: org_study_id