Individual vs. Group Hypnotherapy in Patients With Irritable Bowel Syndrome

Sahlgrenska University Hospital

Status: Active, not recruiting

Conditions: IBS - Irritable Bowel Syndrome

Treatments: Other: Hypnotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03432078

686-11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 119 patients

Sex: All

Ages: 18 to 67 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• IBS according to Rome III criteria

Exclusion criteria

• Organic GI disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 2 patient groups

Individual hypnotherapy

Active Comparator group

Description:

Treatment given on a individual basis, face to face.

Treatment:

Other: Hypnotherapy

Group hypnotherapy

Active Comparator group

Description:

Treatment given in a group setting, face to face.

Treatment:

Other: Hypnotherapy