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Individual vs. Group Hypnotherapy in Patients With Irritable Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT03432078
Recruitment Status : Active, not recruiting
First Posted : February 13, 2018
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Magnus Simrén, Sahlgrenska University Hospital, Sweden

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
IBS - Irritable Bowel Syndrome Other: Hypnotherapy Not Applicable

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 follow-up.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : August 15, 2011
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2025

Arm Intervention/treatment
Active Comparator: Individual hypnotherapy
Treatment given on a individual basis, face to face.
Other: Hypnotherapy
Non-pharmacological treatment

Active Comparator: Group hypnotherapy
Treatment given in a group setting, face to face.
Other: Hypnotherapy
Non-pharmacological treatment




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • IBS according to Rome III criteria

Exclusion Criteria:

  • Organic GI disease

Responsible Party: Magnus Simrén, Professor, MD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT03432078     History of Changes
Other Study ID Numbers: 686-11
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases