Ignite Creation Date:
2024-05-06 @ 12:49 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03852745
Status:
UNKNOWN
Last Update Posted:
2021-09-29
First Post:
2018-08-01
Brief Title:
Managing Stress With Inflammatory Bowel Disease
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Managing Stress With Inflammatory Bowel Disease - an Open Trial of a Web-based Intervention
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
This study will recruit persons with Inflammatory Bowel Disease The investigators will contact people in an ongoing study called IMAGINE to recruit persons with high levels of stress anxiety or depression who are interested in a web-based program focused on skills in managing stress anxiety and depression a self-directed psychosocial intervention The goal is to develop an internet-based psychosocial intervention to help persons with inflammatory bowel disease to cope with high levels of stress anxiety or depression
Detailed Description:
Depression and anxiety are highly prevalent in IBD with depression rates almost twice as high for those with IBD compared to the general community and an estimated 30 overall with depression or anxiety Perceived stress is a factor in the development of anxiety and depression These comorbid conditions complicate management of IBD adversely impacting patient outcomes and health and increasing the resource burden to the health care system However comorbid depression and anxiety in IBD patients is undertreated paralleling unmet mental health treatment needs in the general Canadian population Development of alternate modes of effective treatment delivery is vital to enhance access given limited mental health service availability CBT has strong clinical evidence for its effectiveness in treating episodes of depression and anxiety as well as in preventing relapses CBT may be successfully delivered as an internet-based intervention While there are limited data on the efficacy of CBT tailored to the IBD population studies targeting comorbid depression in IBD have resulted in significant mental health improvement A recent study described an internet-based CBT for IBD reported modest outcomes 150 but participants were not selected to have psychiatric comorbidity and the primary outcomes were not improvement in mood or anxiety symptoms The internet-based program used in this study will involve brief modules focused on areas important in managing stress anxiety and depression including
Core Topics 1 About the Program 2 IBD and Stress 3 Commitment to Living Life Fully 4 The Brain-Gut Connection 5 Understanding Anxiety 6 Overcoming Avoidance 7 Depression 8 Behavioural Activation Optional Topics 9 Treatment Options 10 IBD and the Workplace 11 Mindfulness
Procedures Participants will be recruited with the use of a resources informing possible participants about the project Patients expressing an interest in the program will receive a copy of the consent form for the study by email but asked not to sign it They will be asked to schedule a time with the study coordinator to review with consent form discuss any questions about the consent form or the program and at the end to indicate verbally whether or not they provide consent Those who provide consent will complete a brief psychiatric interview with the study coordinator to check for inclusion and exclusion criteria The interview used will be the Mini International Neuropsychiatric Interview MINI for DSM5 Those who meet the inclusion criteria for the study will be sent a survey link to complete a the baseline measures for the programOnce participants are accepted into the study assessments will be completed at baseline week 6 week 12 and during follow up at week 24
Core Topics 1 About the Program 2 IBD and Stress 3 Commitment to Living Life Fully 4 The Brain-Gut Connection 5 Understanding Anxiety 6 Overcoming Avoidance 7 Depression 8 Behavioural Activation Optional Topics 9 Treatment Options 10 IBD and the Workplace 11 Mindfulness
Procedures Participants will be recruited with the use of a resources informing possible participants about the project Patients expressing an interest in the program will receive a copy of the consent form for the study by email but asked not to sign it They will be asked to schedule a time with the study coordinator to review with consent form discuss any questions about the consent form or the program and at the end to indicate verbally whether or not they provide consent Those who provide consent will complete a brief psychiatric interview with the study coordinator to check for inclusion and exclusion criteria The interview used will be the Mini International Neuropsychiatric Interview MINI for DSM5 Those who meet the inclusion criteria for the study will be sent a survey link to complete a the baseline measures for the programOnce participants are accepted into the study assessments will be completed at baseline week 6 week 12 and during follow up at week 24
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H2017228 | OTHER | University of Manitoba | None |