ACTIB trial (Assessing Cognitive behavioural Therapy in Irritable Bowel): Recruitment and Baseline Characteristics
IBS is a common chronic gastrointestinal condition, characterised by abdominal pain, bloating and change in bowel habit. Currently available medications have limited benefit and many experience on-going symptoms which can have significant impact on quality of life. Cognitive behavioural therapy (CBT) for IBS can help but NHS access is very limited. ACTIB is a NIHR HTA funded multicentre trial designed to determine the clinical and cost-effectiveness of therapist telephone delivered CBT and web-based CBT self-management with minimal therapist support compared to treatment as usual in adults with refractory Irritable Bowel Syndrome (IBS). This abstract describes recruitment and baseline characteristics.
Target recruitment: 495 participants over 23 months from Primary and Secondary Care in the South of England and London. A steady recruitment flow was required as therapist CBT resources had a finite capacity to accept participants each month.Population: Adults (≥18 yrs) with refractory IBS: had been offered first-line therapies (eg, antispasmodics, antidepressants or fibre based medications); continuing IBS symptoms ≥12 months. Those aged >60 yrs must have had a consultant review ≤ 2yrs to exclude serious bowel conditions. Recruitment procedures were informed by the MIBS feasibility study. Potential participants were identified by GP practices and Gastroenterology clinics searching their lists for patients with an IBS diagnosis and sending invite letters, and by opportunistic recruitment. Interested patients returned a reply slip to the study team, had initial telephone screening, completed on-line consent and were invited for blood testing. If bloods were acceptable, participants could be randomised. Baseline and follow up data was patient reported and collected on-line.
15114 invites were sent from 74 GP practices (14,394) and 3 hospital GI clinics (681). 1,479 patients replied, 728 were eligible on screening and consented to the blood test. 558 participants were randomised in 23 months, (464 from primary care).The complexity of screening required several months lead-in prior to the first patient entering the trial. Baseline characteristics: 75.8% (423/558) female; mean age 43yr (95% CI 42.0;44.2); mean duration since diagnosis 10.38 yr (95% CI, 9.57, 11.19) 10.2% had seen a GI consultant; mean IBS-SS score 276.85 (95% CI 269.34, 284.36) indicating moderately severely IBS; mean time from start of symptoms to diagnosis 6.10 yr (95%CI, 5.48, 6.72): 30.3% (169/558) had received treatment for anxiety, 39.85% (222/558) for depression; 53.5% (299/558) qualified to at least degree level; 1.1% had joined a self-help organisation.
Recruitment above target was achieved. An experienced Trial manager, staggered initiation of sites, clear delegation of duties, meticulous data recording and constant perseverance were key. Baseline characteristics indicate recruitment of a similar population to expected, apart from a higher educational level, which we will explore during analysis.