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

• DOI: 10.3310/hta23170
• Publication Date: 2019-05-01T13:41:07Z
• Authors: Hazel Everitt; Sabine Landau; Paul Little; Felicity L Bishop; Gillian O’Reilly; Alice Sibelli; Rachel Holland; Stephanie Hughes; Sula Windgassen; Paul McCrone; Kim Goldsmith; Nicholas Coleman; Robert Logan; Trudie Chalder; Rona Moss-Morris
• Keywords: Bloating

Background Irritable bowel syndrome (IBS) affects 10–22% of people in the UK. Abdominal pain, bloating and altered habits affect quality life can lead to time off work. Current treatment relies on a positive diagnosis, reassurance, lifestyle advice drug therapies, but many suffer ongoing symptoms. Cognitive–behavioural therapy (CBT) is recommended guidelines for patients with symptoms its availability limited. Objectives To determine clinical effectiveness cost-effectiveness therapist telephone-delivered CBT (TCBT) web-based (WCBT) minimal support compared as usual (TAU) refractory IBS. Design This was three-arm randomised controlled trial. Setting trial took place UK primary secondary care. Participants Adults IBS (clinically significant 12 months despite first-line therapies) were recruited from 74 general practices three gastroenterology centres May 2014 March 2016. Interventions TCBT – patient self-management manual, six 60-minute telephone sessions over 9 weeks two booster at 4 8 (8 hours’ time). WCBT interactive, tailored CBT, 30-minute boosters (2.5 Main outcome measures Primary outcomes symptom severity score (IBS SSS) Work Social Adjustment Scale (WSAS) months. Cost-effectiveness [quality-adjusted life-years (QALYs) health-care costs]. Results In total, 558 out 1452 (38.4%) screened eligibility 186 TCBT, 185 187 TAU. The mean baseline Bowel Syndrome Symptom Severity Score 265.0. An intention-to-treat analysis multiple imputation carried months; SSS 61.6 points lower arm [95% confidence interval (CI) 89.5 33.8; p < 0.001] 35.2 (95% CI 57.8 12.6; = 0.002) than TAU 205.6). WSAS 10.8 arm, 3.5 5.1 1.9; 0.001) 3.0 4.6 1.3; 0.001). For outcomes, Subject’s Global Assessment showed an improvement (responders) 84.8% 41.7% [odds ratio (OR) 6.1, 95% 2.5 15.0; 75.0% (OR 3.6, 2.0 6.3; Patient enablement 78.3% 23.5% 9.3, 4.5 19.3; 54.8% 3.5, 5.9; Adverse events similar between arms. incremental (ICER) (QALY) versus £22,284 £7724. reduced after missing values. Qualitative findings highlighted that, arms, there increased capacity cope symptoms, negative emotions challenges daily life. Therapist input important supporting WCBT. Conclusions this large, rigorously conducted RCT, both arms improvements had costs per QALY TCBT. Sustained are possible acceptable cost. Suggested future research work longer-term follow-up translate these into practice. Future Longer-term practice needed. Trial registration Controlled Trials ISRCTN44427879. Funding project funded by National Institute Health Research (NIHR) Technology (HTA) programme will be published full ; Vol. 23, No. 17. See NIHR Journals Library website further information. University Southampton sponsored study. received HTA Board Clinical Network Network.