Individual vs. Group Hypnotherapy in Patients With Irritable Bowel Syndrome
Primary Purpose
IBS - Irritable Bowel Syndrome
Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hypnotherapy
Sponsored by
About this trial
This is an interventional treatment trial for IBS - Irritable Bowel Syndrome
Eligibility Criteria
Inclusion Criteria:
- IBS according to Rome III criteria
Exclusion Criteria:
- Organic GI disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Individual hypnotherapy
Group hypnotherapy
Arm Description
Treatment given on a individual basis, face to face.
Treatment given in a group setting, face to face.
Outcomes
Primary Outcome Measures
Change of Gastrointestinal symptom severity
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03432078
First Posted
February 7, 2018
Last Updated
October 24, 2022
Sponsor
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT03432078
Brief Title
Individual vs. Group Hypnotherapy in Patients With Irritable Bowel Syndrome
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 15, 2011 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS - Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Individual hypnotherapy
Arm Type
Active Comparator
Arm Description
Treatment given on a individual basis, face to face.
Arm Title
Group hypnotherapy
Arm Type
Active Comparator
Arm Description
Treatment given in a group setting, face to face.
Intervention Type
Other
Intervention Name(s)
Hypnotherapy
Intervention Description
Non-pharmacological treatment
Primary Outcome Measure Information:
Title
Change of Gastrointestinal symptom severity
Description
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.
Time Frame
Up to ten years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
IBS according to Rome III criteria
Exclusion Criteria:
Organic GI disease
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35505463
Citation
Lovdahl J, Tornblom H, Ringstrom G, Palsson OS, Simren M. Randomised clinical trial: individual versus group hypnotherapy for irritable bowel syndrome. Aliment Pharmacol Ther. 2022 Jun;55(12):1501-1511. doi: 10.1111/apt.16934. Epub 2022 May 3.
Results Reference
derived
Learn more about this trial
Individual vs. Group Hypnotherapy in Patients With Irritable Bowel Syndrome
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