Abstract

Background: Sleep disorders may worsen clinical, psychological and social situation in patients with IBD. Cognitive behavioral therapy (CBT) is used in chronical disorders and insomnia, which has good results.

Hypothesis: CBT program can improve quality of sleep in patients with IBD.

Aim: To determine effectiveness of the program about quality of sleep(QS) and life(QL) in patients with IBD.

Methods: Randomized trial with 15 subjects from Hospital Universitario del Henares, randomly assigned in 1:1 (experimental: comparison group).

Inclusion criteria: outpatients in clinical remission or mild activity; age:18-65, male/female; IBD? 6 months; bad QS determined by the Pittsburgh Sllep Quality Index (PSQI):score>5.

Dependent variable: quality of health, determined by the PSQI and Insomnia Severity Index (ISI). Data will be collected in Clinical Records and self-administered questionnaires.

A descriptive analysis will be developed, both globally and in groups, calculation of mean and standard deviation and percentage. Correlation between dependent and independent variables will be estimated with Chi-Square test and Students-t. Confidence interval (CI) will be 95% and p<0.05 as p-value. Logistic regression will be undergone to determine association between QS and independent variables, by calculating odds ratio with a 95% CI.