Multicentre trial of combined cognitive behavioural therapy and antidepressant treatment in functional bowel disorders

INTERVENTION: Group 1: cognitive behaviour therapy (CBT), once a week for 12 weeks Group 2: desipramine, up to 150 mg/day for 12 weeks Group 3: combined CBT plus desipramine: CBT once a week and desipramine administered weekly up to 150 mg/day for 12 weeks Contact for public queries: Adrienne Amato Research Co‐ordinator Social Equity & Health Research Centre for Addiction & Mental Health 455 Spadina Ave, Suite 300 Toronto, Ontario M5S 2G8 Canada Tel: +1 416 979 4296 Fax: +1 416 979 6811 Email: adrienne_amato@camh.net CONDITION: Functional bowel disorders ; Digestive System ; Bowel disorders PRIMARY OUTCOME: Composite measure consisting of: ; 1. Satisfaction with treatment; 2. Global well being; 3. Pain ratings; 4. Health related quality of life; ; Points two to four above will be measured at pre‐treatment, post‐treatment, three month follow up and six month follow up. SECONDARY OUTCOME: Four outcomes of composite measure will be analysed separately as secondary variables:; 1. Satisfaction with treatment: post‐treatment, three month follow up, six month follow up; 2. Global well being: pre‐treatment, post‐treatment, three month follow up, six month follow up; 3. Pain ratings: pre‐treatment, end of treatment, three month follow up, six month follow up; 4. Health related quality of life: post‐treatment, three month follow up, six month follow up INCLUSION CRITERIA: 1. Literate, female patients aged 18 to 65 years 2. Symptoms present at least two days per week for greater than six months 3. Diagnosis of painful functional bowel disorder (later subcategorised using Rome II Criteria as irritable bowel syndrome [IBS], functional abdominal pain syndrome, painful constipation or unspecified functional bowel disorder [FBD]) 4. Moderate (MFBD) or severe (SFBD) functional bowel disorder (FBD) based on the Functional Bowel Disorder Severity Index (FBDSI) that we developed. SFBD is defined as a score more than 110, and MFBD as a score between 36 and 110. Patients with mild symptoms (less than 36) will be excluded, since the proposed treatments would not be cost‐effective nor clinically needed.