Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512597
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Behavioral Therapy for Crohns Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Combination Therapy of Resilience Intervention With Biologics in Crohns Disease CATHARSIS Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
People living with Crohns disease CD experience psychological and emotional symptoms in addition to known chronic and disabling physical symptoms which prevent them from living their life to the fullest flourishing Depression and anxiety are experienced by 30 of people living with CD and 60 of inflammatory bowel disease IBD patients continue to report chronic pain stress sleeplessness and fatigue even when they are objectively in remission Psychological stress has been endorsed by 70 of patients with IBD as a key trigger for disease activity which is not surprising given the significance of the gut-brain-microbiome axis the close communication between the enteric and autonomic nervous systems and the role of the hypothalamic-pituitary axis and its neuroendocrine and immune functions in the expression of GI symptoms Interestingly up to 85 of patients with CD also endorse the positive impact of effective coping skills on disease course The PIs prior work has suggested that early provision of effective coping strategies offered at the time of diagnosis or more precisely immediately prior to biologic medication initiation could potentially result in faster healing and improved well-being likely through the combination of 1 physiological mitigation of the stress response and optimization of the gut-brain-microbiome axis and 2 promotion of effective coping and disease self-management behaviors that promote psychological flourishing despite disease Unfortunately to date early effective psychosocial care has been limited by concerns over reimbursement for psychological services access to qualified IBD mental health professionals and the lack of a standardized methodology focused on the brain-gut stress response and how to assess monitor communicate and maintain tight control over both physical and emotional well-being CATHARSIS is a rigorous placebo-controlled randomized controlled trial of coping strategies plus medication for 170 people living with Crohns for less than 5 years who are about to start a new biologic medication due to active disease Outcomes include improvements in emotional well-being as well as clinical and endoscopic remission over a 12-month period The overall goal of the study is to demonstrate that it is essential to combine biologic therapy and psychosocial care to ensure optimal and long-term positive outcomes in CD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None