Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04756414
Status:
COMPLETED
Last Update Posted:
2022-04-08
First Post:
2021-02-11
Brief Title:
Clinical Effectiveness of Exposure Based Cognitive Behavioral Group Therapy for IBS
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Clinical Effectiveness of Exposure Based Cognitive Behavioral Group Therapy for IBS
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 avoidancecontrol 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
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 avoidancecontrol 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None