Therapist telephone-delivered CBT and web-based CBT compared with treatment as usual in refractory irritable bowel syndrome: the ACTIB three-arm RCT

• Published in: Health technology assessment (Winchester, England) England), 2019-04, Vol.23 (17), p.1-154
• Main Authors: Everitt, Hazel, Landau, Sabine, Little, Paul, Bishop, Felicity L, O'Reilly, Gillian, Sibelli, Alice, Holland, Rachel, Hughes, Stephanie, Windgassen, Sula, McCrone, Paul, Goldsmith, Kim, Coleman, Nicholas, Logan, Robert, Chalder, Trudie, Moss-Morris, Rona
• Format: Article
• Language: English
• Subjects: Adult; Cognitive Behavioral Therapy; COGNITIVE–BEHAVIOURAL THERAPY; Cost-Benefit Analysis; DIGITAL INTERVENTION; Female; Humans; Internet; IRRITABLE BOWEL SYNDROME; Irritable Bowel Syndrome - physiopathology; Irritable Bowel Syndrome - psychology; Male; Middle Aged; Outcome Assessment, Health Care; Quality of Life; RANDOMISED CONTROLLED TRIAL; Remote Consultation - methods; SELF-MANAGEMENT; Surveys and Questionnaires; Telemedicine - economics; Young Adult
• ISSN: 1366-5278; 2046-4924
• DOI: 10.3310/hta23170

Irritable bowel syndrome (IBS) affects 10-22% of people in the UK. Abdominal pain, bloating and altered bowel habits affect quality of life and can lead to time off work. Current treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many people suffer ongoing symptoms. Cognitive-behavioural therapy (CBT) is recommended in guidelines for patients with ongoing symptoms but its availability is limited. To determine the clinical effectiveness and cost-effectiveness of therapist telephone-delivered CBT (TCBT) and web-based CBT (WCBT) with minimal therapist support compared with treatment as usual (TAU) in refractory IBS. This was a three-arm randomised controlled trial. This trial took place in UK primary and secondary care. Adults with refractory IBS (clinically significant symptoms for 12 months despite first-line therapies) were recruited from 74 general practices and three gastroenterology centres from May 2014 to March 2016. TCBT - patient CBT self-management manual, six 60-minute telephone sessions over 9 weeks and two 60-minute booster sessions at 4 and 8 months (8 hours' therapist time). WCBT - interactive, tailored web-based CBT, three 30-minute telephone sessions over 9 weeks and two 30-minute boosters at 4 and 8 months (2.5 hours' therapist time). Primary outcomes - IBS symptom severity score (IBS SSS) and Work and Social Adjustment Scale (WSAS) at 12 months. Cost-effectiveness [quality-adjusted life-years (QALYs) and health-care costs]. In total, 558 out of 1452 patients (38.4%) screened for eligibility were recruited - 186 were randomised to TCBT, 185 were randomised to WCBT and 187 were randomised to TAU. The mean baseline Irritable Bowel Syndrome Symptom Severity Score (IBS SSS) was 265.0. An intention-to-treat analysis with multiple imputation was carried out at 12 months; IBS SSS were 61.6 points lower in the TCBT arm [95% confidence interval (CI) 89.5 to 33.8;