Inflammatory Bowel Disease
Conditions
Brief summary
Main aim is to evaluate the role of stress in the evolution of inflammatory bowel disease (IBD) and the quality of life of these patients. A second aim is to establish the existence of any psicopathological profile in these patients. We designed a prospective experimental study were patients are randomized to receive or not a cognitive-behavior program. Patients will be evaluated at 3 and 12 months after the program and study variables will be measured: stress level, coping strategies, quality of life, activity of disease and biological variables related to IBD.
Interventions
BEHAVIORALCognitive-behavior interventional program
Sponsors
Asociación Española de Gastroenterología
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-85 years * Informed consent * Crohn's disease or ulcerative colitis diagnosis * Active disease in the last 18 months
Exclusion criteria
* Severe mental disease * Other severe concomitant disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in IBD activity at short and long-term | Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months | Number of clinical episodes of activity of IBD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in stress scales at short and long-term | Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months | Perceived Stress Scale (PSS) |
| Change in quality of life at short and long-term | Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months | Inflammatory bowel disease quality-of-life scale (IBDQ) |
| Change in anxiety and depression at short and long-term | Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months | HAD scale |
Countries
Spain
Outcome results
None listed