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Gut. 2019 Apr 10. pii: gutjnl-2018-317805. doi: 10.1136/gutjnl-2018-317805. [Epub ahead of print]

Assessing telephone-delivered cognitive-behavioural therapy (CBT) and web-delivered CBT versus treatment as usual in irritable bowel syndrome (ACTIB): a multicentre randomised trial.

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.

KEYWORDS:

cognitive-behavioural therapy; irritable bowel syndrome; randomised controlled trial

PMID:
30971419
DOI:
10.1136/gutjnl-2018-317805
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Conflict of interest statement

Competing interests: PL is the director of PGfAR and a member of the Journals Library Board. RMM reports personal fees from training in IBS intervention for Central and North West London NHS Foundation Trust and University of East Anglia, outside the submitted work. TC reports grants from Guy’s and St Thomas’ Charity. She was a faculty member, Third International Conference on Functional (Psychogenic) Neurological Disorders, September 2017, Edinburgh, member of the IAPT Education and Training ERG (2016–), member of the IAPT Outcomes and Informatics Meeting (2016–) and president of the British Association of Behavioural and Cognitive Psychotherapies (2012–2015) for which she did not receive payment. Workshops were delivered on medically unexplained symptoms, during the conduct of the study (money paid into KCL for future research). TC has a patent background IP—manuals were developed prior to trial starting. SL and KG report grants from NIHR. The TSC chair, PW, was a colleague of TC in the past but he has recently retired. RMM reports personal fees from training in IBS intervention for Central and North West London NHS Foundation Trust and University of East Anglia, outside the submitted work. Since this study was submitted, she has received payment for consultancy to Mahana Therapeutics. The CBT patient and the therapist manual used in the telephone CBT arm are freely available on the National Improving Access to Psychological Therapies (IAPT) for LTC/MUS website as part of evidence-based resources for IAPT. The patient manual is background IP developed by CI’s RMM and TC in previous work. The therapist manual was developed for the ACTIB trial. These manuals were only made available once the 12-month ACTIB follow-up was complete. HAE, FB, GOR, AS, RH, SL, SH, SW, PMC, NC and RL have nothing to disclose.

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