Stress and Personality Profiles in IBD

Study Overview
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Brief Summary
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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.

Official Title
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Effect of the Stress and Personality Profiles in the Development, Evolution and Treatment of Inflammatory Bowel Disease.

Conditions
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Inflammatory Bowel Disease

Intervention / Treatment
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* Behavioral: Cognitive-behavior interventional program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychological intervention<br>Cognitive-behavior interventional program | Behavioral: Cognitive-behavior interventional program<br> <br> |
| No Intervention: Control<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in IBD activity at short and long-term | Number of clinical episodes of activity of IBD | Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months | 
| Change in IBD activity at short and long-term | Number of hospital admisions because of IBD | Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months | 
| Change in IBD activity at short and long-term | Activity index vaules (CDAI for Crohn's disease and Mayo score for ulcerative colitis) | Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in stress scales at short and long-term | Perceived Stress Scale (PSS) | Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months | 
| Change in quality of life at short and long-term | Inflammatory bowel disease quality-of-life scale (IBDQ) | Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months | 
| Change in anxiety and depression at short and long-term | HAD scale | Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months | 
| Change in stress scales at short and long-term | Disease related stress scale (EAE) | Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months | 
| Change in stress scales at short and long-term | Vital stressors scale (AVE) | Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months | 
| Change in stress scales at short and long-term | stress coping questionnaire (CAE) | Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months |