Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04646785
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2020-11-16
Brief Title:
Mindfulness-based Cognitive Therapy for Patients With Inflammatory Bowel Disease
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Mindfulness-based Cognitive Therapy to Improve Stress and Sleep in Patients With Inflammatory Bowel Disease
Status:
COMPLETED
Status Verified Date:
2024-01
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:
Considering the limited availability of psychosocial interventions for IBD this study aims to investigate MBCT as an adjunctive treatment to treatment as usual to reduce psychological stress and improve sleep qualityregularity in patients with IBD who report elevated stress levels The study will have a follow-up duration of 12 months from baseline
Detailed Description:
Introduction
Inflammatory bowel diseases IBD are chronic inflammatory diseases of the intestinal tract consisting of crohns disease CD and ulcerative colitis UC In The Netherlands there are about 90000 IBD patients mainly young adults who are in a turbulent part of their life with starting a family and career The prevalence of IBD seems to be rising The peak incidence is between 15 and 30 years The disease is characterized by periods of disease activity flares alternating with periods of clinical remission Physical symptoms include abdominal pain diarrhea rectal bleeding and fatigue Although the arsenal of drugs has increased in recent decades there is no cure for the disease and patients are usually long-term treated with different immunosuppressive medications Nevertheless at this moment we are only partially able to keep our IBD patients in remission
Even in those in remission IBD is associated with increased levels of psychological stress with estimated prevalence rates of 21 for depressive symptoms and 35 for anxiety symptoms In periods of disease activity prevalence of elevated anxiety levels was even found to be as high as 756 Besides psychological stress IBD patients in remission report lower quality of life compared to the general population This is due to the physical symptoms but also to fatigue worries anxiety depression impaired satisfaction with social role and sleep disturbances More than 40 of the IBD patients experience fatigue This may contribute to the higher sick leave days and higher work impairment rates in quiescent IBD causing high societal costs In addition poor sleep seems common in individuals with IBD and has been linked to disease activity and shown as a predictor for subclinical inflammation and a risk factor for relapse and poorer outcomes
Mindfulness training typically in the form of mindfulness-based stress reduction MBSR or mindfulness-based cognitive therapy MBCT is a psychosocial group-based intervention that has been shown to reduce psychological distress and improving quality of life both in patients with mental health problems and those with chronic diseases such as diabetes cancer cardiovascular disease rheumatoid arthritis and fibromyalgia Mindfulness training focuses on the progressive acquisition of mindful awareness to better cope with negative repetitive thoughts and feelings and for that reason may be a good option to reduce psychological stress and fatigue and improve quality of life in patients with chronic conditions including IBD
Although the available literature on the effectiveness of mindfulness-based interventions for IBD is still relatively scarce a recent meta-analysis showed significant benefits in terms of stress depression and quality of life However the variety in types of interventions was rather high and individual studies typically suffered from methodological limitations including small sample size poor blinding of the outcome assessors incomplete data reporting and a relative lack of fidelity measures Therefore it seems warranted to conduct a high-quality multicenter randomized controlled trial investigating the effectiveness of MBCT to improve stress sleep quality and quality of life
Aims
Considering the limited availability of psychosocial interventions for IBD this study aims to investigate MBCT as an adjunctive treatment to TAU to reduce psychological stress in patients with IBD who report elevated stress levels In addition we aim to improve sleep qualityregularity and fatigue IBD-related quality of life perceived control over IBD clinical indicators fecal calprotectin c-reactive protein levels Harvey Brashaw Index for CD Simple Clinical Colitis Activity Index for UC IBD-related flare We also aim to improve repetitive negative thinking mindfulness skills self-compassion skills and positive mental health We will investigate whether improving sleep quality may be one of the pathways through which mindfulness may help reduce psychological distress and improve quality of life in IBD working mechanism
Method
A two-armed randomized multicenter parallel group pragmatic trial comparing Mindfulness-Based Cognitive Therapy MBCT vs Treatment As Usual TAU for reducing psychological distress in distressed patients with Inflammatory Bowel Disease IBD Assessments will be conducted at baseline post treatment 3 months and follow-ups at 6 9 and 12 months Objective sleep measures will be taken at baseline post treatment and 12 months
The control group will receive treatment as usual TAU according to Dutch and European IBD treatment guidelines The intervention group will receive Mindfulness-Based Cognitive Therapy MBCT in addition to TAU The MBCT protocol that will be used is based on the protocol published by Segal Williams and Teasdale MBCT consists of eight weekly 25h group sessions a six-hour silent day and daily home practice assignments guided by audio files Mindfulness is characterized by deliberate non-judging and sustained moment-to-moment awareness Health related benefits include enhanced emotional processing and coping regarding the effects of chronic illness and stress improved self-efficacy and control and a more accepting attitude towards difficult emotions thought and bodily sensations Psycho-education and interactive dialogue typically focus on stress management balancing activities lifestyle factors and strategies to stay well in the future relapse prevention Each group will be comprising 8-12 participants MBCT courses will be taught on site by qualified mindfulness teachers Teacher competency will be assessed with the Mindfulness-Based Interventions - Teaching Assessment Criteria using a random selection of videotaped sessions assessed by expert teachers who have been trained to use these assessment criteria
Inflammatory bowel diseases IBD are chronic inflammatory diseases of the intestinal tract consisting of crohns disease CD and ulcerative colitis UC In The Netherlands there are about 90000 IBD patients mainly young adults who are in a turbulent part of their life with starting a family and career The prevalence of IBD seems to be rising The peak incidence is between 15 and 30 years The disease is characterized by periods of disease activity flares alternating with periods of clinical remission Physical symptoms include abdominal pain diarrhea rectal bleeding and fatigue Although the arsenal of drugs has increased in recent decades there is no cure for the disease and patients are usually long-term treated with different immunosuppressive medications Nevertheless at this moment we are only partially able to keep our IBD patients in remission
Even in those in remission IBD is associated with increased levels of psychological stress with estimated prevalence rates of 21 for depressive symptoms and 35 for anxiety symptoms In periods of disease activity prevalence of elevated anxiety levels was even found to be as high as 756 Besides psychological stress IBD patients in remission report lower quality of life compared to the general population This is due to the physical symptoms but also to fatigue worries anxiety depression impaired satisfaction with social role and sleep disturbances More than 40 of the IBD patients experience fatigue This may contribute to the higher sick leave days and higher work impairment rates in quiescent IBD causing high societal costs In addition poor sleep seems common in individuals with IBD and has been linked to disease activity and shown as a predictor for subclinical inflammation and a risk factor for relapse and poorer outcomes
Mindfulness training typically in the form of mindfulness-based stress reduction MBSR or mindfulness-based cognitive therapy MBCT is a psychosocial group-based intervention that has been shown to reduce psychological distress and improving quality of life both in patients with mental health problems and those with chronic diseases such as diabetes cancer cardiovascular disease rheumatoid arthritis and fibromyalgia Mindfulness training focuses on the progressive acquisition of mindful awareness to better cope with negative repetitive thoughts and feelings and for that reason may be a good option to reduce psychological stress and fatigue and improve quality of life in patients with chronic conditions including IBD
Although the available literature on the effectiveness of mindfulness-based interventions for IBD is still relatively scarce a recent meta-analysis showed significant benefits in terms of stress depression and quality of life However the variety in types of interventions was rather high and individual studies typically suffered from methodological limitations including small sample size poor blinding of the outcome assessors incomplete data reporting and a relative lack of fidelity measures Therefore it seems warranted to conduct a high-quality multicenter randomized controlled trial investigating the effectiveness of MBCT to improve stress sleep quality and quality of life
Aims
Considering the limited availability of psychosocial interventions for IBD this study aims to investigate MBCT as an adjunctive treatment to TAU to reduce psychological stress in patients with IBD who report elevated stress levels In addition we aim to improve sleep qualityregularity and fatigue IBD-related quality of life perceived control over IBD clinical indicators fecal calprotectin c-reactive protein levels Harvey Brashaw Index for CD Simple Clinical Colitis Activity Index for UC IBD-related flare We also aim to improve repetitive negative thinking mindfulness skills self-compassion skills and positive mental health We will investigate whether improving sleep quality may be one of the pathways through which mindfulness may help reduce psychological distress and improve quality of life in IBD working mechanism
Method
A two-armed randomized multicenter parallel group pragmatic trial comparing Mindfulness-Based Cognitive Therapy MBCT vs Treatment As Usual TAU for reducing psychological distress in distressed patients with Inflammatory Bowel Disease IBD Assessments will be conducted at baseline post treatment 3 months and follow-ups at 6 9 and 12 months Objective sleep measures will be taken at baseline post treatment and 12 months
The control group will receive treatment as usual TAU according to Dutch and European IBD treatment guidelines The intervention group will receive Mindfulness-Based Cognitive Therapy MBCT in addition to TAU The MBCT protocol that will be used is based on the protocol published by Segal Williams and Teasdale MBCT consists of eight weekly 25h group sessions a six-hour silent day and daily home practice assignments guided by audio files Mindfulness is characterized by deliberate non-judging and sustained moment-to-moment awareness Health related benefits include enhanced emotional processing and coping regarding the effects of chronic illness and stress improved self-efficacy and control and a more accepting attitude towards difficult emotions thought and bodily sensations Psycho-education and interactive dialogue typically focus on stress management balancing activities lifestyle factors and strategies to stay well in the future relapse prevention Each group will be comprising 8-12 participants MBCT courses will be taught on site by qualified mindfulness teachers Teacher competency will be assessed with the Mindfulness-Based Interventions - Teaching Assessment Criteria using a random selection of videotaped sessions assessed by expert teachers who have been trained to use these assessment criteria
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