Irritable Bowel SyndromeNCT02737410
Resilience in Irritable Bowel Syndrome and Gut-focused Hypnotherapy
A study testing Gut-directed Hypnotherapy in people with Irritable Bowel Syndrome, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Gut-directed Hypnotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnancy, mental retardation
- insufficient knowledge of German
- transit time from home to hospital longer than one hour
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resilience in Irritable Bowel Syndrome and Gut-focused Hypnotherapy: Longitudinal Study With Hypnotherapy Patients and Cross Sectional Control Group
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.
Read more
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.
Read the 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
- Being tested
- Gut-directed Hypnotherapy
- Keywords
- Resilience, Coping, Psychosomatic, Hypnosis, Construct Validation
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gut-directed HypnotherapyBehavioural
Also called Gut-focused 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).
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Treatment group obtaining Gut-directed Hypnotherapy Receives: Behavioral: Gut-directed Hypnotherapy |
| Control | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience assessed using the Connor-Davidson Resilience Scale
10-item Connor-Davidson Resilience Scale, with higher values indicating higher resilience.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Secondary outcomes (3)
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.
Measured: 1 year
Quality of life assessed by visual analogue scales
Quality of life was assessed via single visual analogue scales (VAS). Higher values represent higher wellbeing.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startJun 2012
- Primary completionJun 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Moser, Medical University of Vienna
- Investigators
- Gabriele Moser, Professor, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737410
- Sponsor's protocol ID
- 1488/2012
- Status last verified
- Apr 2016
- First submitted
- 20 Jan 2016
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: via www.figshare.com
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilience in Irritable Bowel Syndrome and Gut-focused Hypnotherapy: Longitudinal Study With Hypnotherapy Patients and Cross Sectional Control Group
- ClinicalTrials.gov ID
- NCT02737410
- Acronym / sponsor ID
- 1488/2012
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Resilience, Coping, Psychosomatic, Hypnosis, Construct Validation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Behavioral: Gut-directed HypnotherapyTreatment group obtaining Gut-directed Hypnotherapy |
| Control | No intervention | –Control group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- pregnancy, mental retardation
- insufficient knowledge of German
- transit time from home to hospital longer than one hour
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gut-directed HypnotherapyAlso: Gut-focused HypnotherapyThe 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). | Behavioural | Treatment |
Primary outcome
Resilience assessed using the Connor-Davidson Resilience Scale
Time frame: 1 year
10-item Connor-Davidson Resilience Scale, with higher values indicating higher resilience.
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.
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.
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.
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.
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.
3 secondary outcomes
Psychological distress assessed by the Hospital Anxiety and Depression Scale
Time frame: 1 year
Quality of life assessed by visual analogue scales
Time frame: 1 year
Symptom severity assessed by the Irritable Bowel Syndrome - Severity Scoring System
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Individual participant dataSharing planned: Yes. via www.figshare.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriele Moser, Professor principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gut-directed Hypnotherapy in people with Irritable Bowel Syndrome, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience assessed using the Connor-Davidson Resilience Scale (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.