OWE-028 Actib trial (assessing cognitive behavioural therapy in irritable bowel): a multicentre randomised controlled trial

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Abstract

Introduction

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.

Methods

ACTIB is a National institute for Health Research (NIHR) multicentre randomised controlled trial. Participants: Adults (≥18 years) 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) or Web-based CBT self-management with minimal therapist support (WCBT) 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: Intention-to-treat with multiple imputation at 12 months.

Results

558/1452 (38.4%) patients screened for eligibility recruited: 186 randomised to TCBT, 185 WCBT, 187 TAU. Mean baseline IBS SSS 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: TAU=10.8 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) 84.8% responders TCBT at 12 months compared to 41.7% TAU OR 6.1 (95% CI 2.5; 15.0; p<0.001) and 75.0% for WCBT OR 3.5 (95% CI 2.0 to 6.1; p<0.001). Patient enablement (PEQ) 78.3% responders TCBT, 23.5% TAU OR 9.2 (95% CI 4.3; 19.4; p<0.001) and 54.8% for WCBT OR 3.6 (95% CI 2.1; 6.1; p<0.001).

Conclusions

To date, this is the largest trial of CBT for IBS worldwide. Both CBT arms showed significant improvements in IBS outcomes compared to TAU, sustained at 12 months. TCBT had larger effects than WCBT. CBT for IBS can be effectively delivered to a broad range of patients with refractory IBS.

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