Everitt HA¹, Landau S², O'Reilly G¹, Sibelli A³, Hughes S¹, Windgassen S³, Holland R², Little P¹, McCrone P⁴, Bishop F⁵, Goldsmith K², Coleman N⁶, Logan R⁷, Chalder T^#8, Moss-Morris R^#3; ACTIB trial group. Gut. 2019 Apr 10. pii: gutjnl-2018-317805. doi: 10.1136/gutjnl-2018-317805. [Epub ahead of print]

Author information

1 Primary Care and Population Sciences, University of Southampton, Southampton, UK.

2 Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College, London, UK.

3 Department of Psychology, Institue of Psychiatry, Psychology and Neuroscience, King's College, London, UK.

4 Department of Health Services and Population Research, Institute of Psychiatry, Psychology and Neuroscience, King's College, London, UK.

5 Department of Psychology, University of Southampton, Southampton, UK.

6 Department of Gastroenterology, University Hospital Southampton, Southampton, UK.

7 Department of Gastroenterology, King's College Hospital, London, UK.

8 Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College, London, UK.

# Contributed equally

Abstract

OBJECTIVE: To evaluate the clinical effectiveness of two modes of cognitive-behavioural therapy (CBT) for IBS compared with treatment as usual (TAU) in refractory IBS.

DESIGN: A three-arm randomised controlled trial assessing telephone-delivered CBT (TCBT), web-based CBT (WCBT) with minimal therapist support, and TAU. Blinding participants and therapists was not possible. Chief investigator, assessors and statisticians were blinded. Participants were adults with refractory IBS (clinically significant symptoms for ≥12 months despite first-line therapies), recruited by letter and opportunistically from 74 general practices and three gastroenterology centres in London and South of England between May 2014 to March 2016. Co-primary outcomes were IBS Symptom Severity Score (IBS-SSS) and Work and Social Adjustment Scale (WSAS) at 12 months.

RESULTS: 558/1452 (38.4%) patients screened for eligibility were randomised: 76% female: 91% white: mean age 43 years. (391/558) 70.1% completed 12 months of follow-up. Primary outcomes: Compared with TAU (IBS-SSS 205.6 at 12 months), IBS-SSS was 61.6 (95% CI 33.8 to 89.5) points lower (p<0.001) in TCBT and 35.2 (95% CI 12.6 to 57.8) points lower (p=0.002) in WCBT at 12 months. Compared with TAU (WSAS score 10.8 at 12 months) WSAS was 3.5 (95% CI 1.9 to 5.1) points lower (p<0.001) in TCBT and 3.0 (95% CI 1.3 to 4.6) points lower (p=0.001) in WCBT. All secondary outcomes showed significantly greater improvement (p≤0.002) in CBT arms compared with TAU. There were no serious adverse reactions to treatment.

CONCLUSION: Both CBT interventions were superior to TAU up to 12 months of follow-up.

TRIAL REGISTRATION NUMBER: ISRCTN44427879.