- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03432078
Individual vs. Group Hypnotherapy in Patients With Irritable Bowel Syndrome
November 30, 2023 updated by: Magnus Simrén, Sahlgrenska University Hospital, Sweden
Comparison of Effects Between Gut Directed Hypnotherapy Provided Either Individually or in a Group Setting for Patients With Irritable Bowel Syndrome (IBS) a Randomized Controlled Study.
Patients' fulfilling Rome III criteria for IBS with symptoms refractory to standard treatment who are referred to a specialist unit for hypnotherapy are consecutively included in the study.
The patients are randomized to either individual or group treatment given by a nurse trained in hypnotherapy.
The treatment consists of eight sessions of gut directed hypno therapy during twelve weeks.
Effects are measured by validated questionnaires at baseline and at various time points during the treatment period as well as after the completion of the treatment.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Patients' fulfilling Rome III criteria for IBS with symptoms refractory to standard treatment who are referred to a specialist unit for hypnotherapy are consecutively included in the study.
Firstly, the patients are invited to a meeting with the nurse for information about the study, check for eligibility and to sign the written informed consent.
Exclusion criteria that could influence GI symptoms such as organic GI disease, severe psychiatric comorbidity and pregnancy are controlled for.
The patients are randomized to either individual or group treatment given by a nurse trained in hypnotherapy and cognitive behavioral therapy.
The randomization is organized and performed in blocks by an external unit connected to the University in order to be accurate.
The treatment consists of eight sessions of gut directed hypnotherapy during twelve weeks.
A standardized protocol is used and is the same both in the group setting as well as in the individual treatment arm.
In each group approximately eight patients are included.
Every session lasts for one hour.
Outcome measures in the study are GI symptom severity, GI-specific anxiety, psychological distress and health related quality of life.
These effects are measured by validated questionnaires at baseline and at various time points during the treatment period as well as after the completion of the treatment and during the 6 months-, 1 and 2 year follow-up.
Study Type
Interventional
Enrollment (Actual)
119
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Gothenburg, Sweden, 41345
- Dept of Internal Medicine, Sahlgrenska University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 67 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- IBS according to Rome III criteria
Exclusion Criteria:
- Organic GI disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Individual hypnotherapy
Treatment given on a individual basis, face to face.
|
Non-pharmacological treatment
|
Active Comparator: Group hypnotherapy
Treatment given in a group setting, face to face.
|
Non-pharmacological treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Gastrointestinal symptom severity
Time Frame: Up to ten years
|
Measured with Irritable Bowel Syndrome- severity scoring system (IBS-SSS).
The questionnaire measures severity of GI symptoms and consists of five questions where each score ranges from 0 to 100.
A total score of all five questions is calculated ranging from 0 to 500.
The higher the score the more severe the GI symptoms.
|
Up to ten years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2011
Primary Completion (Actual)
December 31, 2019
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
February 7, 2018
First Submitted That Met QC Criteria
February 7, 2018
First Posted (Actual)
February 13, 2018
Study Record Updates
Last Update Posted (Estimated)
December 7, 2023
Last Update Submitted That Met QC Criteria
November 30, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 686-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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