Skip to content

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03432078
Enrollment
119
Registered
2018-02-13
Start date
2011-08-15
Completion date
2025-12-31
Last updated
2023-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBS - Irritable Bowel Syndrome

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.

Interventions

OTHERHypnotherapy

Non-pharmacological treatment

Sponsors

Sahlgrenska University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 67 Years
Healthy volunteers
No

Inclusion criteria

* IBS according to Rome III criteria

Exclusion criteria

* Organic GI disease

Design outcomes

Primary

MeasureTime frameDescription
Change of Gastrointestinal symptom severityUp to ten yearsMeasured 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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026