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

NCT05328245 | Completed

• 1 other identifier: IPSY-IBS
• Study Type: observational
• Target: 319
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome; Effectiveness; Cognitive Behavioral Therapy; Exposure; Internet; Mediation

Outcome Measures

Primary Outcomes (4)

• The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS)

  It is a self-rating scale with 13 questions regarding the severity of the IBS-symptoms. The questions can be rated from 1-7, where 1 represents no discomfort at all and 7 means very severe discomfort. The total score may range from 13-91. The GSRS-IBS has demonstrated good psychometric properties for the different symptoms that are assessed, with an internal consistency (Cronbach's a) of .88 \[17\] and test-retest reliability between .55 and .70

  pre treatment (same day as treatment starts),

• Change from baseline IBS-symptoms measured with The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS)

  It is a self-rating scale with 13 questions regarding the severity of the IBS-symptoms. The questions can be rated from 1-7, where 1 represents no discomfort at all and 7 means very severe discomfort. The total score may range from 13-91. The GSRS-IBS has demonstrated good psychometric properties for the different symptoms that are assessed, with an internal consistency (Cronbach's a) of .88 \[17\] and test-retest reliability between .55 and .70

  weekly during treatment (ten times in total, during the ten week long treatment)

• The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS)

  It is a self-rating scale with 13 questions regarding the severity of the IBS-symptoms. The questions can be rated from 1-7, where 1 represents no discomfort at all and 7 means very severe discomfort. The total score may range from 13-91. The GSRS-IBS has demonstrated good psychometric properties for the different symptoms that are assessed, with an internal consistency (Cronbach's a) of .88 \[17\] and test-retest reliability between .55 and .70

  post treatment (same day as treatment ends). 10 weeks after treatment start.

• The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS)

  It is a self-rating scale with 13 questions regarding the severity of the IBS-symptoms. The questions can be rated from 1-7, where 1 represents no discomfort at all and 7 means very severe discomfort. The total score may range from 13-91. The GSRS-IBS has demonstrated good psychometric properties for the different symptoms that are assessed, with an internal consistency (Cronbach's a) of .88 \[17\] and test-retest reliability between .55 and .70

  follow-up (six months after the treatment ended),

Secondary Outcomes (14)

• The Irritable bowel Syndrome - Behavioral Responses Questionnaire (IBS-BRQ)

  pre treatment (same day as treatment starts)

• Change from baseline avoidance behaviors measured with The Irritable bowel Syndrome - Behavioral Responses Questionnaire (IBS-BRQ)

  weekly during treatment (ten times in total, during the ten week long treatment)

• The Irritable bowel Syndrome - Behavioral Responses Questionnaire (IBS-BRQ)

  post treatment (same day as treatment ends), ten weeks after treatment start

• The Irritable bowel Syndrome - Behavioral Responses Questionnaire (IBS-BRQ)

  follow-up (six months after the treatment ended),

• Visceral Sensitivity Index (VSI)

  pre treatment (same day as treatment starts)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Related Publications (2)

• 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.

  PMID: 9243433 BACKGROUND

• 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.

  PMID: 39194012 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome; Negotiating

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Communication; Behavior

Study Officials

• Brjánn Ljótsson, Ass. Prof.

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 14, 2022
• Study Start: April 1, 2015
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share