ACTIB trial (Assessing Cognitive behavioural Therapy in Irritable Bowel): a multicentre randomised controlled trial
Irritable Bowel Syndrome (IBS) is a common chronic gastrointestinal condition, characterised by abdominal pain, bloating and change in bowel habit. Medications have limited benefit and many patients experience ongoing symptoms with significant impact on quality of life. Cognitive behavioural therapy (CBT) for IBS is recommended in NICE guidelines but NHS access is very limited. Objective: To determine the clinical 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 IBS.
ACTIB is a National institute for Health Research (NIHR) multicentre randomised controlled trial. Participants: Adults (≥18 yrs) with refractory IBS who had been offered first-line therapies (eg, antispasmodics, antidepressants or fibre-based medications) and had continuing IBS symptoms ≥12 months, were recruited over 23 months from primary and secondary care in the south of England and London. The interventions were therapist telephone delivered CBT (TCBT) (8 hours therapist time) with a patient CBT manual and homework tasks, or Web-based CBT self-management with minimal therapist support (WCBT) (2 ½ hours therapist time) versus treatment as usual (TAU). Main outcome measures: IBS Symptom Severity Score (IBS SSS) and Work and Social Adjustment Scale (WSAS). Baseline and follow up data was patient reported and collected on-line at 3, 6 and 12 months. Analysis was Intention-to-treat with multiple imputation at 12 months.
558/1452 (38.4%) patients screened for eligibility were recruited: 186 randomised to TCBT, to 185 WCBT, and to 187 TAU. Mean baseline IBS SSS was 265.0. At 12 months TAU IBS SSS score was 205.6, compared to 61.6 points lower for TCBT (95% CI 89.5; 33.8; p<0.001) and 35.5 lower for WCBT (95% CI 58.0; 13.1; p=0.002). WSAS score was 10.8 in the TAU group at 12 months and 3.5 lower with TCBT (95% CI 5.1; 1.9; p<0.001), 3.0 points lower with WCBT (95% CI 4.6; 1.3; p<0.001). Secondary outcomes: Subjects Global improvement of symptoms (SGA) had 84.8% responders in the TCBT group at 12 months compared to 41.7% in TAU OR 6.1 (95% CI 2.5; 15.0; p<0.001) and 75.0% in the WCBT group OR 3.5 (95% CI 2.0 to 6.1; p<0.001). Patient enablement (PEQ) had 78.3% responders in the TCBT group, 23.5% in TAU OR 9.2 (95% CI 4.3; 19.4; p<0.001) and 54.8% in the WCBT OR 3.6 (95% CI 2.1; 6.1; p<0.001).
Both CBT arms showed significant improvements in IBS outcomes compared to TAU, which were sustained at 12 months. TCBT had larger effects than WCBT. We believe this is the largest trial of CBT for IBS worldwide. The results suggest that CBT for IBS could be effectively delivered to a broad range of NHS patients with refractory IBS.