Ignite Creation Date:
2024-05-05 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 9:49 AM
Study NCT ID:
NCT00679003
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2008-05-14
Brief Title:
Managing Inflammatory Bowel Disease
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Psychosocial Intervention for Children With IBD
Status:
COMPLETED
Status Verified Date:
2015-04
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:
Managing IBD
Brief Summary:
Inflammatory Bowel Disease Crohns disease and ulcerative colitis often results in significant life disruption hospitalization and surgery While psychosocial factors are not believed to cause IBD such factors can contribute to the ability of individuals with IBD to cope with the disease and ineffective coping may lead to the exacerbation of IBD symptoms The goal of this study is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with IBD The primary outcomes of interest are IBD symptoms medical visits quality of life and overall disability
Detailed Description:
Inflammatory Bowel Disease Crohns and ulcerative colitis IBD a serious medical condition that affects children and adolescents is often associated with high rates of health care utilization and disability including school absences While psychosocial factors are not believed to cause IBD research suggests that they may increase illness-related dysfunction Prior studies suggest that response to chronic illness is in part acquired during childhood through social learning processes and may be modified with psychosocial interventions This randomized controlled trial will compare a social learning and cognitive behavior therapy SLCBT treatment to an education and support condition ES 180 children with IBD will be recruited and followed for 12 months It is hypothesized that SLCBT participants compared to those in the ES condition will at one-year follow-up 1 exhibit greater decreases in IBD symptoms medical visits for IBD and functional disability and greater increases in quality of life 2 demonstrate greater use of cognitive coping relaxation and stress management skills and their parents will demonstrate greater reductions in maladaptive responses to illness behavior and 3 exhibit greater reductions in anxiety depression and somatization Results will lead to innovative interventions for IBD and other chronic childhood medical conditions
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HD050345-01A2 | NIH | None | httpsreporternihgovquickSearch1R01HD050345-01A2 |