A randomized controlled trial of a cognitive behavioural therapy-based self-management intervention for irritable bowel syndrome in primary care

Background. Recent guidelines for the treatment of irritable bowel syndrome (IBS) emphasize the need for research to facilitate home-based self-management for these patients in primary care. The aim of the current study was to test the efficacy of a manualized cognitive behavioural therapy (CBT)-based self-management programme for IBS in a pilot randomized controlled trial (RCT). Method. Sixty-four primary-care patients meeting Rome criteria for FBS were randomized into either self-management plus treatment as usual (TAU) (n = 31) or a TAU control condition (n = 33). The self-management condition included a structured 7-week manualized programme that was self-administered in conjunction with a 1-hour face-to-face therapy session and two 1-hour telephone sessions. The primary outcome measures were the Subject's Global Assessment (SGA) of Relief and the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) assessed at baseline, end of treatment (2 months), and 3 and 6 months post-treatment. Results. Analysis was by intention-to-treat. Twenty-three (76.7%) of the self-management group rated themselves as experiencing symptom relief across all three time periods compared to seven (21.2%) of the TAU controls [odds ratio (OR) 12.2, 95% confidence interval (CI) 3.72-40.1]. At 8 months, 25 (83%) of the self-management group showed a clinically significant change on the IBS-SSS compared to 16 (49%) of the control group (OR 5.3, 95% CI 1.64-17.26). Conclusions. This study provides preliminary evidence that CBT-based self-management in the form of a structured manual and minimal therapist contact is an effective and acceptable form of treatment for primary-care IBS patients.