Clinical Effectiveness of Exposure Based Cognitive Behavioral Group Therapy for IBS
1 other identifier
interventional
143
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2009
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2014
CompletedFirst Submitted
Initial submission to the registry
February 11, 2021
CompletedFirst Posted
Study publicly available on registry
February 16, 2021
CompletedApril 8, 2022
March 1, 2022
6 years
February 11, 2021
March 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gastro-Intestinal Symptom Rating Scale for IBS Gastrointestinal Symptom Rating Scale - IBS version
Change in gastrointestinal symptoms measured with a self-rating scale from baseline to 10 weeks, and from baseline to 9 months for analysis of effect.The GSRS-IBS have 13 items about weekly gastrointestinal symptoms like bloating, hard stool, abdominal pain etc. It is a seven-point Likert scale from 1 (no discomfort at all) to 7 (very severe discomfort). The GSRS-IBS has excellent psychometric properties with internal consistency between α = .74 (for abdominal pain) to α = .85 (for satiety).
Baseline to 10 veeks
Secondary Outcomes (3)
Quality of Life in persons with Irritable Bowel Syndrome (QOL-IBS)
Baseline to 10 veeks
Visceral Sensitivity Index (VSI)
Baseline to 10 veeks
The Montgomery-Åsberg Depression Rating Scale (MADRS-S)
Baseline to 10 veeks
Study Arms (1)
Treatment group
EXPERIMENTALPatients 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).
Interventions
See under detailed description
Eligibility Criteria
You may qualify if:
- \- Diagnosed with IBS
You may not qualify if:
- Severe psychiatric condition (for example severe depression, self injuring, psychosis, PTSD)
- Unable or unwilling to participate in group therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 35260030DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Perjohan Lindfors, PhD, MD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
February 11, 2021
First Posted
February 16, 2021
Study Start
January 1, 2009
Primary Completion
December 31, 2014
Study Completion
December 31, 2014
Last Updated
April 8, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share