Ignite Creation Date:
2024-05-06 @ 8:24 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02737410
Status:
COMPLETED
Last Update Posted:
2016-04-13
First Post:
2016-01-20
Brief Title:
Resilience in Irritable Bowel Syndrome and Gut-focused Hypnotherapy
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Resilience in Irritable Bowel Syndrome and Gut-focused Hypnotherapy Longitudinal Study With Hypnotherapy Patients and Cross Sectional Control Group
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
N74 Gastroenterology outpatients with Irritable Bowel Syndrome Rome III criteria were examined in 7 resilience domains quality of life psychological distress and symptom severity n53 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
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
N74 Gastroenterology outpatients with Irritable Bowel Syndrome Rome III criteria were examined in 7 resilience domains quality of life psychological distress and symptom severity n53 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
N74 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 andor 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 14882012 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
Study location and recruitment
N74 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 andor 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 14882012 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None