Resilience in Irritable Bowel Syndrome and Gut-focused Hypnotherapy

NCT02737410 | Completed

• 1 other identifier: 1488/2012
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

Resilience; Coping; Psychosomatic; Hypnosis; Construct Validation

Outcome Measures

Primary Outcomes (6)

• Resilience assessed using the Connor-Davidson Resilience Scale

  10-item Connor-Davidson Resilience Scale, with higher values indicating higher resilience.

  1 year

• Self-efficacy assessed by the Skala zur allgemeinen Selbstwirksamkeitserwartung

  Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) is a german questionnaire to assess self-efficacy. Higher values mean higher self-efficacy.

  1 year

• Humor assessed by the State-Trait Cheerfulness Inventory

  State-Trait Cheerfulness Inventory, german version (STCI); higher values indicate higher predisposition to experience positive emotion by humor.

  1 year

• Social support assessed by the Fragebogen zur Sozialen Unterstützung

  Fragebogen zur Sozialen Unterstützung (F-SozU), a german Questionnaire assessing perceived social support, with higher values indicating higher perceived support.

  1 year

• Emotion regulation assessed by the Cognitive Emotion Regulation Questionnaire

  Cognitive Emotion Regulation Questionnaire (CERQ), german version; assessing adaptive and dysfunctional cognitive reactions to aversive events. Higher values represent higher occurence of respective behaviours.

  1 year

• Neuroticism assessed by the Big Five Inventory

  Big Five Inventory, german short form (BFI-K), for assessment of neuroticism. Higher values indicate higher neuroticism.

  1 year

Secondary Outcomes (3)

• Psychological distress assessed by the Hospital Anxiety and Depression Scale

  1 year

• Quality of life assessed by visual analogue scales

  1 year

• Symptom severity assessed by the Irritable Bowel Syndrome - Severity Scoring System

  1 year

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Treatment group obtaining Gut-directed Hypnotherapy

Behavioral: Gut-directed Hypnotherapy

Control

NO INTERVENTION

Control group

Interventions

Gut-directed Hypnotherapy 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).

Also known as: Gut-focused Hypnotherapy

Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Gabriele Moser, Professor

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: April 13, 2016
• Study Start: June 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 13, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)