Nurse-administered, Gut-directed Hypnotherapy for Patients With Irritable Bowel Syndrome (IBS).

Study Overview
=================
Brief Summary
-----------------
Adult IBS patients with symptoms refractory to standard medical treatment received nurse-administered, gut-directed hypnotherapy. The primary outcome measure was change in gastro-intestinal symptom severity.

Detailed Description
-----------------
IBS patients with symptoms refractory to standard treatment and who were referred to a specialist unit for hypnotherapy, were consecutively included in the study. The patients received gut-directed hypnotherapy given by a nurse trained in Cognitive Behavioral Therapy (CBT) and hypnotherapy. Between 2005 and 2015 patients received 8-12 sessions in an individual manner for 12 weeks. From 2016 the treatment was given in a group format. Effects of treatment were measured by validated questionnaires at baseline and at various time points during the treatment period, as well as after the completion of the treatment at follow-up 6 months, 1 and 2 years after treatment.

Official Title
-----------------
Nurse-administered, Gut-directed Hypnotherapy for Patients With Irritable Bowel Syndrome (IBS).

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Behavioral: Gut-directed hypnotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IBS diagnosis. - Exclusion Criteria: Organic GI disease. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nurse-delivered, gut-directed hypnotherapy<br>Adult patients suffering from irritable bowel syndrome (IBS), with symptoms refractory to standard treatment. Patients referred to a tertiary care center were included. | Behavioral: Gut-directed hypnotherapy<br>* Gut-directed hypnotherapy for patients with irritable bowel syndrome (IBS). Gut-directed hypnotherapy (8-12 sessions), were given either in an individual manner or in a group setting.The hypnosis treatment is administered by two nurses specially trained in Cognitive Behavioral Therapy (CBT) and hypnotherapy. The treatment was based on the North Carolina protocol. Patients assessed gastro-intestinal symptom severity before, during and after treatment, as well as at follow-up.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 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. | Baseline (week 0), during treatment (week 6), at treatment completion (week 8), follow-up (6 months, 1 and 2 years after treatment initiation) |