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Resilience in Irritable Bowel Syndrome and Gut-focused Hypnotherapy

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ClinicalTrials.gov Identifier: NCT02737410
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : April 13, 2016
Sponsor:
Information provided by (Responsible Party):
Gabriele Moser, Medical University of Vienna

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.


Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Behavioral: Gut-directed Hypnotherapy Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Resilience in Irritable Bowel Syndrome and Gut-focused Hypnotherapy: Longitudinal Study With Hypnotherapy Patients and Cross Sectional Control Group
Study Start Date : June 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Active Comparator: Treatment
Treatment group obtaining Gut-directed Hypnotherapy
Behavioral: 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).
Other Name: Gut-focused Hypnotherapy

No Intervention: Control
Control group



Primary Outcome Measures :
  1. Resilience assessed using the Connor-Davidson Resilience Scale [ Time Frame: 1 year ]
    10-item Connor-Davidson Resilience Scale, with higher values indicating higher resilience.

  2. Self-efficacy assessed by the Skala zur allgemeinen Selbstwirksamkeitserwartung [ Time Frame: 1 year ]
    Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) is a german questionnaire to assess self-efficacy. Higher values mean higher self-efficacy.

  3. Humor assessed by the State-Trait Cheerfulness Inventory [ Time Frame: 1 year ]
    State-Trait Cheerfulness Inventory, german version (STCI); higher values indicate higher predisposition to experience positive emotion by humor.

  4. Social support assessed by the Fragebogen zur Sozialen Unterstützung [ Time Frame: 1 year ]
    Fragebogen zur Sozialen Unterstützung (F-SozU), a german Questionnaire assessing perceived social support, with higher values indicating higher perceived support.

  5. Emotion regulation assessed by the Cognitive Emotion Regulation Questionnaire [ Time Frame: 1 year ]
    Cognitive Emotion Regulation Questionnaire (CERQ), german version; assessing adaptive and dysfunctional cognitive reactions to aversive events. Higher values represent higher occurence of respective behaviours.

  6. Neuroticism assessed by the Big Five Inventory [ Time Frame: 1 year ]
    Big Five Inventory, german short form (BFI-K), for assessment of neuroticism. Higher values indicate higher neuroticism.


Secondary Outcome Measures :
  1. Psychological distress assessed by the Hospital Anxiety and Depression Scale [ Time Frame: 1 year ]
    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.

  2. Quality of life assessed by visual analogue scales [ Time Frame: 1 year ]
    Quality of life was assessed via single visual analogue scales (VAS). Higher values represent higher wellbeing.

  3. Symptom severity assessed by the Irritable Bowel Syndrome - Severity Scoring System [ Time Frame: 1 year ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737410


Locations
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Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Gabriele Moser, Professor Medical University of Vienna

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Responsible Party: Gabriele Moser, Professor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02737410    
Other Study ID Numbers: 1488/2012
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: via www.figshare.com
Keywords provided by Gabriele Moser, Medical University of Vienna:
Resilience
Coping
Psychosomatic
Hypnosis
Construct Validation
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases