search
Back to results

Resilience in Irritable Bowel Syndrome and Gut-focused Hypnotherapy

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Gut-directed Hypnotherapy
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Irritable Bowel Syndrome focused on measuring Resilience, Coping, Psychosomatic, Hypnosis, Construct Validation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Treatment

Control

Arm Description

Treatment group obtaining Gut-directed Hypnotherapy

Control group

Outcomes

Primary Outcome Measures

Resilience assessed using the Connor-Davidson Resilience Scale
10-item Connor-Davidson Resilience Scale, with higher values indicating higher resilience.
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.
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.
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.
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.
Neuroticism assessed by the Big Five Inventory
Big Five Inventory, german short form (BFI-K), for assessment of neuroticism. Higher values indicate higher neuroticism.

Secondary Outcome Measures

Psychological distress assessed by the Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (German version, HADS-D) is an instrument for screening anxiety and depression in primarily somatic ill patients. Higher values indicate more distress.
Quality of life assessed by visual analogue scales
Quality of life was assessed via single visual analogue scales (VAS). Higher values represent higher wellbeing.
Symptom severity assessed by the Irritable Bowel Syndrome - Severity Scoring System
The Irritable Bowel Syndrome - Severity Scoring System (IBS-SSS) is a questionnaire for clinical assessment of IBS symptom burden and severity. Higher values indicate higher symptom burden.

Full Information

First Posted
January 20, 2016
Last Updated
April 12, 2016
Sponsor
Medical University of Vienna
search

1. Study Identification

Unique Protocol Identification Number
NCT02737410
Brief Title
Resilience in Irritable Bowel Syndrome and Gut-focused Hypnotherapy
Official Title
Resilience in Irritable Bowel Syndrome and Gut-focused Hypnotherapy: Longitudinal Study With Hypnotherapy Patients and Cross Sectional Control Group
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Resilience, Coping, Psychosomatic, Hypnosis, Construct Validation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
Treatment group obtaining Gut-directed Hypnotherapy
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Behavioral
Intervention Name(s)
Gut-directed Hypnotherapy
Other Intervention Name(s)
Gut-focused Hypnotherapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Resilience assessed using the Connor-Davidson Resilience Scale
Description
10-item Connor-Davidson Resilience Scale, with higher values indicating higher resilience.
Time Frame
1 year
Title
Self-efficacy assessed by the Skala zur allgemeinen Selbstwirksamkeitserwartung
Description
Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) is a german questionnaire to assess self-efficacy. Higher values mean higher self-efficacy.
Time Frame
1 year
Title
Humor assessed by the State-Trait Cheerfulness Inventory
Description
State-Trait Cheerfulness Inventory, german version (STCI); higher values indicate higher predisposition to experience positive emotion by humor.
Time Frame
1 year
Title
Social support assessed by the Fragebogen zur Sozialen Unterstützung
Description
Fragebogen zur Sozialen Unterstützung (F-SozU), a german Questionnaire assessing perceived social support, with higher values indicating higher perceived support.
Time Frame
1 year
Title
Emotion regulation assessed by the Cognitive Emotion Regulation Questionnaire
Description
Cognitive Emotion Regulation Questionnaire (CERQ), german version; assessing adaptive and dysfunctional cognitive reactions to aversive events. Higher values represent higher occurence of respective behaviours.
Time Frame
1 year
Title
Neuroticism assessed by the Big Five Inventory
Description
Big Five Inventory, german short form (BFI-K), for assessment of neuroticism. Higher values indicate higher neuroticism.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Psychological distress assessed by the Hospital Anxiety and Depression Scale
Description
The Hospital Anxiety and Depression Scale (German version, HADS-D) is an instrument for screening anxiety and depression in primarily somatic ill patients. Higher values indicate more distress.
Time Frame
1 year
Title
Quality of life assessed by visual analogue scales
Description
Quality of life was assessed via single visual analogue scales (VAS). Higher values represent higher wellbeing.
Time Frame
1 year
Title
Symptom severity assessed by the Irritable Bowel Syndrome - Severity Scoring System
Description
The Irritable Bowel Syndrome - Severity Scoring System (IBS-SSS) is a questionnaire for clinical assessment of IBS symptom burden and severity. Higher values indicate higher symptom burden.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriele Moser, Professor
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
via www.figshare.com

Learn more about this trial

Resilience in Irritable Bowel Syndrome and Gut-focused Hypnotherapy

We'll reach out to this number within 24 hrs