Clinical trial NCT03432078: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: IBS - Irritable Bowel Syndrome
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 the 6 months-, 1 and 2 year follow-up.

Eligibility criteria: Inclusion Criteria:

* IBS according to Rome III criteria

Exclusion Criteria:

* Organic GI disease

Primary outcomes:
measure: Change of Gastrointestinal symptom severity
timeFrame: Up to ten years
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dept of Internal Medicine, Sahlgrenska University Hospital
Study officials:
References:
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.