Clinical Effectiveness of Exposure Based Cognitive Behavioral Group Therapy for IBS

Karolinska Institute

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Behavioral: Exposure based face-to-face Cognitive Behavior Group Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04756414

IBS-Sabb

Details and patient eligibility

About

The aim of the study is to evaluate the effects of a specific Cognitive Behavioral treatment protocol for patients with IBS used in routine care at a gastroenterology unit in Stockholm. The research question is whether the treatment has the same effects in routine care as it has had in efficacy studies.

The treatment is given by licenced psychologists (with CBT training) face-to-face in groups of 4-7 participants and lasts for ten sessions (ten weeks, normally).

Full description

IBS is a debilitating condition that affects approximately one out of eleven persons world wide. It is often called a functional disorder, a term used to characterize painful conditions, whose biological mechanisms are not fully understood.

Diagnosis is made based on symptoms and exclusion of other conditions rather than specific tests or biological markers.

Treatment usually starts with diet counselling and a change of eating habits. If symptoms persist, a physician can prescribe medication of different types. But for some patients neither change of diet, nor medication is sufficient. Some of these patients may benefit from psychological treatment. There are a few different psychological treatments that have been proven efficacious in clinical trials. Most researched is Cognitive Behavior Therapy (CBT).

Our study is a clinical effectiveness trial without a control group. The data comes from a gastroenterology clinic in Stockholm and is collected as part of the work with continous improvement at the clinic.

Patients with diagnosed IBS are offered group treatment with a specific CBT protocol developed by our research group at Karolinska Institutet. The treatment comprises 6 different modules and stretches over ten sessions. The modules are: 1. Information regarding the treatment, IBS and mindfulness. 2 Hypervigilance and anxiety. 3. Behaviors and thoughts. 4. Behavior change part one - toilet habits including exposure to feared situations. 5. Behavior change part two - exposure to symptoms and avoidance/control behaviors. 6. Summary and relapse prevention.

Group sizes range from 4-7 patients and the treatment is given by licenced psychologists who are employed at the clinic.

Enrollment: 143 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with IBS

Exclusion criteria

• Severe psychiatric condition (for example severe depression, self injuring, psychosis, PTSD)
• Unable or unwilling to participate in group therapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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143 participants in 1 patient group

Treatment group

Experimental group

Description:

Patients recieve treatment from standard protocol at a gastroenterology unit. No specific adjustments is made for study purposes. Baseline data is collected before treatment and then again after treatment (POST).

Treatment:

Behavioral: Exposure based face-to-face Cognitive Behavior Group Therapy