Internet-delivered Exposure-based Cognitive Behavior Therapy for Irritable Bowel Syndrome - a Cohort Effectiveness Study

NCT ID: NCT05328245

Last Updated: 2022-04-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 319 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-01
• Study Completion Date: 2022-01-31

Brief Summary

The main purpose of the study is to investigate the clinical real-world effectiveness of a specific exposure based psychological treatment for irritable bowel syndrome (IBS). A secondary aim of the study is to find mediators of the treatment effect and thereby learn something about the working mechanism of the treatment.

Detailed Description

IBS is a debilitating disorder with a prevalence of 10% world wide. For patients with severe forms of IBS where medication and other interventions have failed it can be useful to try psychological treatment. National Institute for Health and Care Excellence (NICE) guidelines recommend cognitive behavior therapy or hypnotherapy.

Our research group at the Karolinska Institute in Stockholm has developed a cognitive behavioral treatment protocol for IBS. This treatment contains exposure therapy and mindfulness based exercises alongside psychoeducation. The treatment has been tested in four earlier randomized controlled trials (RCT) and produced large effect sizes compared to wait-list and moderate effect sizes compared to other active treatments or placebo.

The present study aims to examine the effectiveness of the treatment protocol under real-world circumstances at a secondary-care unit in Stockholm.

The Internet psychiatry Unit (IPSY) has been operative since 2007 and is run by Region Stockholm (i.e. the responsible authority for all publicly-funded healthcare in Stockholm). Patients with IBS have been treated at the clinic since 2015 and the treatment is delivered via an online treatment platform. The study is based on the clinics own data that has been collected for quality improvement reasons. Another aim of the study is to find out more about the working mechanisms behind the treatment by examining the weekly reports on behavioral avoidance and and anxiety that the patients file during treatment. All patients that have been treated at the clinic so far will be included in the study (N=319). Data has been collected between April 2015 and January 2022.

The study has an approved ethical permit from the Swedish Authority for Ethical Approvals.

The first hypothesis is that the treatment will be as effective in clinical routine care as it has been in earlier trials with a moderate to large effect-size from pre treatment to follow-up, six month after treatment. A second hypothesis is that the treatment effect is mediated by a change in behavioral avoidance that precedes symptomatic improvement.

Conditions

Irritable Bowel Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of IBS made by a licenced physician
• Able to provide written certificate of the diagnosis
• At least 16 years of age
• Daily access to computer, mobile phone or tablet with internet
• Account at health care guide 1177
• Proficient in Swedish

Exclusion Criteria

• Considered having a high risk for suicide
• Unable to read or communicate in written form
• Do not understand Swedish language
• has planned to be away for more than 2 weeks during the treatment period
• suffers from another somatic or psychiatric condition needing to be prioritized or that might hinder treatment

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

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Brjann Ljotsson

Principal Investigator, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brjánn Ljótsson, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

References

Jenkinson C, Layte R, Jenkinson D, Lawrence K, Petersen S, Paice C, Stradling J. A shorter form health survey: can the SF-12 replicate results from the SF-36 in longitudinal studies? J Public Health Med. 1997 Jun;19(2):179-86. doi: 10.1093/oxfordjournals.pubmed.a024606.

Reference Type: BACKGROUND

PMID: 9243433 (View on PubMed)

Wallen H, Ljotsson B, Lindfors P, Forsell E, Hesser H, Svanborg C. Internet-Delivered Exposure-Based Cognitive Behavior Therapy for Irritable Bowel Syndrome: A Clinical Effectiveness Study. Am J Gastroenterol. 2025 Apr 1;120(4):856-863. doi: 10.14309/ajg.0000000000003059. Epub 2024 Aug 28.

Reference Type: DERIVED

PMID: 39194012 (View on PubMed)

Other Identifiers

IPSY-IBS

Identifier Type: -

Identifier Source: org_study_id