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

Assessing telephone-delivered cognitive–behavioural therapy (CBT) and web-delivered CBT versus treatment as usual in irritable bowel syndrome (ACTIB): a multicentre randomised trial
Assessing telephone-delivered cognitive–behavioural therapy (CBT) and web-delivered CBT versus treatment as usual in irritable bowel syndrome (ACTIB): a multicentre randomised trial
PDFNeurogastroenterologyOriginal articleAssessing telephone-delivered cognitive–behavioural therapy (CBT) and web-delivered CBT versus treatment as usual in irritable bowel syndrome (ACTIB): a multicentre randomised trial Hazel Anne Everitt1, Sabine Landau2, Gilly O’Reilly1, Alice Sibelli3, Stephanie Hughes1, Sula Windgassen3, Rachel Holland2, Paul Little1, Paul McCrone4, Felicity Bishop5, Kimberley Goldsmith2, Nicholas Coleman6, Robert Logan7, Trudie Chalder8, Rona Moss-Morris3 on behalf of ACTIB trial groupAuthor affiliations Primary Care and Population Sciences, University of Southampton, Southampton, UK Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King’s College, London, UK Department of Psychology, Institue of Psychiatry, Psychology and Neuroscience, King’s College, London, UK Department of Health Services and Population Research, Institute of Psychiatry, Psychology and Neuroscience, King’s College, London, UK Department of Psychology, University of Southampton, Southampton, UK Department of Gastroenterology, University Hospital Southampton, Southampton, UK Department of Gastroenterology, King’s College Hospital, London, UK Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King’s College, London, UK Correspondence to Associate Prof Hazel Anne Everitt, Primary Care and Population Sciences, Southampton University, Southampton SO16 5ST, UK; hae1@soton.ac.uk AbstractObjective 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.
1468-3288
1-11
Everitt, Hazel
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Landau, Sabine
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O'reilly, Gilly
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Sibelli, Alice
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Hughes, Stephanie
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Windgassen, Sula
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Holland, Rachel
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Little, Paul
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McCrone, Paul
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Bishop, Felicity
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Goldsmith, Kimberley
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Coleman, Nicholas
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Logan, Robert
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Chalder, Trudie
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Moss-Morris, Rona
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O'reilly, Gilly
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Hughes, Stephanie
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Windgassen, Sula
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Holland, Rachel
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Little, Paul
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McCrone, Paul
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Bishop, Felicity
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Logan, Robert
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Chalder, Trudie
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Moss-Morris, Rona
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Everitt, Hazel, Landau, Sabine, O'reilly, Gilly, Sibelli, Alice, Hughes, Stephanie, Windgassen, Sula, Holland, Rachel, Little, Paul, McCrone, Paul, Bishop, Felicity, Goldsmith, Kimberley, Coleman, Nicholas, Logan, Robert, Chalder, Trudie and Moss-Morris, Rona (2019) Assessing telephone-delivered cognitive–behavioural therapy (CBT) and web-delivered CBT versus treatment as usual in irritable bowel syndrome (ACTIB): a multicentre randomised trial. Gut, 1-11. (doi:10.1136/gutjnl-2018-317805).

Record type: Article

Abstract

PDFNeurogastroenterologyOriginal articleAssessing telephone-delivered cognitive–behavioural therapy (CBT) and web-delivered CBT versus treatment as usual in irritable bowel syndrome (ACTIB): a multicentre randomised trial Hazel Anne Everitt1, Sabine Landau2, Gilly O’Reilly1, Alice Sibelli3, Stephanie Hughes1, Sula Windgassen3, Rachel Holland2, Paul Little1, Paul McCrone4, Felicity Bishop5, Kimberley Goldsmith2, Nicholas Coleman6, Robert Logan7, Trudie Chalder8, Rona Moss-Morris3 on behalf of ACTIB trial groupAuthor affiliations Primary Care and Population Sciences, University of Southampton, Southampton, UK Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King’s College, London, UK Department of Psychology, Institue of Psychiatry, Psychology and Neuroscience, King’s College, London, UK Department of Health Services and Population Research, Institute of Psychiatry, Psychology and Neuroscience, King’s College, London, UK Department of Psychology, University of Southampton, Southampton, UK Department of Gastroenterology, University Hospital Southampton, Southampton, UK Department of Gastroenterology, King’s College Hospital, London, UK Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King’s College, London, UK Correspondence to Associate Prof Hazel Anne Everitt, Primary Care and Population Sciences, Southampton University, Southampton SO16 5ST, UK; hae1@soton.ac.uk AbstractObjective 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.

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Accepted/In Press date: 22 February 2019
e-pub ahead of print date: 10 April 2019

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Local EPrints ID: 429733
URI: https://eprints.soton.ac.uk/id/eprint/429733
ISSN: 1468-3288
PURE UUID: 61bd649c-5d5e-4231-8753-5597d8e1a2be
ORCID for Hazel Everitt: ORCID iD orcid.org/0000-0001-7362-8403
ORCID for Felicity Bishop: ORCID iD orcid.org/0000-0002-8737-6662

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Date deposited: 04 Apr 2019 16:30
Last modified: 30 Apr 2019 00:36

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