Clinical trial NCT05328245: Internet-delivered Exposure-based Cognitive Behavior Therapy for Irritable Bowel Syndrome - a Cohort Effectiveness Study
Official title: The Effectiveness of Internet-delivered Exposure-based Cognitive Behavior Therapy for Irritable Bowel Syndrome - a Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
Effectiveness
Cognitive Behavioral Therapy
Exposure
Internet
Mediation
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2022-04-14
Enrollment: 319
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients that were treated for IBS at the Internet psychiatry unit in Stockholm from the opening of the unit (april 2015) until january 2022.

The study population is believed to be representative of Swedish IBS-patients that have undergone the first steps of treatment for IBS (i.e. life style counseling, dietary advice and tried various medications) but still suffer significantly from their symptoms.

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.

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

Primary outcomes:
measure: The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS)
timeFrame: pre treatment (same day as treatment starts),
measure: Change from baseline IBS-symptoms measured with The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS)
timeFrame: weekly during treatment (ten times in total, during the ten week long treatment)
measure: The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS)
timeFrame: post treatment (same day as treatment ends). 10 weeks after treatment start.
measure: The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS)
timeFrame: follow-up (six months after the treatment ended),
Secondary outcomes:
measure: The Irritable bowel Syndrome - Behavioral Responses Questionnaire (IBS-BRQ)
timeFrame: pre treatment (same day as treatment starts)
measure: Change from baseline avoidance behaviors measured with The Irritable bowel Syndrome - Behavioral Responses Questionnaire (IBS-BRQ)
timeFrame: weekly during treatment (ten times in total, during the ten week long treatment)
measure: The Irritable bowel Syndrome - Behavioral Responses Questionnaire (IBS-BRQ)
timeFrame: post treatment (same day as treatment ends), ten weeks after treatment start
measure: The Irritable bowel Syndrome - Behavioral Responses Questionnaire (IBS-BRQ)
timeFrame: follow-up (six months after the treatment ended),
measure: Visceral Sensitivity Index (VSI)
timeFrame: pre treatment (same day as treatment starts)
measure: Visceral Sensitivity Index (VSI)
timeFrame: post treatment (same day as treatment ends), ten weeks after treatment start.
measure: Visceral Sensitivity Index (VSI)
timeFrame: follow-up (six months after the treatment ended)
measure: EuroQoL (EQ-5D)
timeFrame: pre treatment (same day as treatment starts)
measure: EuroQoL (EQ-5D)
timeFrame: post treatment (same day as treatment ends), ten weeks after treatment start.
measure: EuroQoL (EQ-5D)
timeFrame: follow-up (six months after the treatment ended)
measure: Short Form Health Survey (SF-12)
timeFrame: pre treatment (same day as treatment starts)
measure: Short Form Health Survey (SF-12)
timeFrame: post treatment (same day as treatment ends), ten weeks after treatment start.
measure: Change from baseline health status measured with Short Form Health Survey (SF-12)
timeFrame: weekly during treatment (ten times in total, during the ten week long treatment)
measure: Short Form Health Survey (SF-12)
timeFrame: follow-up (six months after the treatment ended)
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Brjánn Ljótsson, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.