Clinical Effectiveness of Exposure Based Cognitive Behavioral Group Therapy for IBS

NCT ID: NCT04756414

Last Updated: 2022-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-01
• Study Completion Date: 2014-12-31

Brief Summary

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).

Detailed 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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

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).

Group Type: EXPERIMENTAL

Exposure based face-to-face Cognitive Behavior Group Therapy

Intervention Type: BEHAVIORAL

See under detailed description

Interventions

Exposure based face-to-face Cognitive Behavior Group Therapy

See under detailed description

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Perjohan Lindfors

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Perjohan Lindfors, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

References

Wallen H, Ljotsson B, Svanborg C, Rydh S, Falk L, Lindfors P. Exposure based cognitive behavioral group therapy for IBS at a gastroenterological clinic - a clinical effectiveness study. Scand J Gastroenterol. 2022 Aug;57(8):904-911. doi: 10.1080/00365521.2022.2047220. Epub 2022 Mar 9.

Reference Type: DERIVED

PMID: 35260030 (View on PubMed)

Other Identifiers

IBS-Sabb

Identifier Type: -

Identifier Source: org_study_id