Individual vs. Group Hypnotherapy in Patients With Irritable Bowel Syndrome
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.
1 other identifier
interventional
119
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 15, 2011
CompletedFirst Submitted
Initial submission to the registry
February 7, 2018
CompletedFirst Posted
Study publicly available on registry
February 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedDecember 7, 2023
November 1, 2023
8.4 years
February 7, 2018
November 30, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Up to ten years
Study Arms (2)
Individual hypnotherapy
ACTIVE COMPARATORTreatment given on a individual basis, face to face.
Group hypnotherapy
ACTIVE COMPARATORTreatment given in a group setting, face to face.
Interventions
Eligibility Criteria
You may qualify if:
- IBS according to Rome III criteria
You may not qualify if:
- Organic GI disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept of Internal Medicine, Sahlgrenska University Hospital
Gothenburg, 41345, Sweden
Related Publications (2)
Lovdahl J, Blomqvist-Storm M, Palsson OS, Ringstrom G, Tornblom H, Simren M, Trindade IA. Nurse-Administered Gut-Directed Hypnotherapy for Irritable Bowel Syndrome: A Two-Year Follow-Up Study. United European Gastroenterol J. 2025 Sep;13(7):1307-1317. doi: 10.1002/ueg2.70060. Epub 2025 Jun 9.
PMID: 40491242DERIVEDLovdahl 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.
PMID: 35505463DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, MD
Study Record Dates
First Submitted
February 7, 2018
First Posted
February 13, 2018
Study Start
August 15, 2011
Primary Completion
December 31, 2019
Study Completion
December 31, 2025
Last Updated
December 7, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share