Clinical trial NCT04756414: Clinical Effectiveness of Exposure Based Cognitive Behavioral Group Therapy for IBS
Official title: Clinical Effectiveness of Exposure Based Cognitive Behavioral Group Therapy for IBS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Cognitive Behavior Therapy, IBS, Group Therapy, Exposure,
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 143
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Gastro-Intestinal Symptom Rating Scale for IBS Gastrointestinal Symptom Rating Scale - IBS version
timeFrame: Baseline to 10 veeks
Secondary outcomes:
measure: Quality of Life in persons with Irritable Bowel Syndrome (QOL-IBS)
timeFrame: Baseline to 10 veeks
measure: Visceral Sensitivity Index (VSI)
timeFrame: Baseline to 10 veeks
measure: The Montgomery-Åsberg Depression Rating Scale (MADRS-S)
timeFrame: Baseline to 10 veeks
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Perjohan Lindfors, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.