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Cognitive behavioural therapy (CBT) for irritable bowel syndrome (IBS): 24 month follow-up of ACTIB trial participants

Cognitive behavioural therapy (CBT) for irritable bowel syndrome (IBS): 24 month follow-up of ACTIB trial participants
Cognitive behavioural therapy (CBT) for irritable bowel syndrome (IBS): 24 month follow-up of ACTIB trial participants
Background: IBS is common, affecting 10-20% of the adult population with many people experiencing ongoing symptoms despite first line therapies. Cognitive behavioural therapy (CBT) is recommended in guidelines for refractory IBS but there is limited access to CBT for IBS and uncertainty whether benefits last in the longer term. ACTIB (Assessing Cognitive behavioural Therapy for IBS) was a large randomised controlled trial of two forms of CBT for patients with refractory IBS. ACTIB results showed, at 12 months, that both forms of CBT for IBS were significantly more effective than treatment as usual (TAU) at reducing IBS symptom severity and impact at 12 months in adults with refractory IBS. This follow-up study aims to evaluate 24 month clinical outcomes of participants recruited to the ACTIB trial. Methods: in the ACTIB three-arm randomised controlled trial, 558 adults with refractory IBS were randomly allocated to therapist-delivered telephone CBT (TCBT), web-based CBT with minimal therapist support (WCBT) or treatment as usual (TAU) and followed up for 12 months. 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 1st May 2014 and 31st March 2016. Primary outcome measures were IBS Symptom Severity Score (IBS-SSS) and Work and Social Adjustment Scale (WSAS) Intention-to-treat (ITT) analyses with multiple imputation were undertaken. This study was a non-pre-specified naturalistic follow-up and analysis of ACTIB trial participants at 24 months. Findings: 24 months follow-up of outcomes was achieved for 57·9% (323/558) participants, (119/186 in the Telephone CBT arm, 99/185 in the Web CBT arm, 105 /187 in the treatment as usual arm). At 24 months compared to treatment as usual: IBS-SSS was 40·5 (95% CI 15·0 to 66·0) points lower (p=0·002) in the Telephone CBT arm and 12·9 (95% CI -12·9 to 38·8) points lower (p=0·325) in the Web CBT arm. WSAS was 3·1 (95% CI 1·3 to 4·9) points lower (p<0·001) in the Telephone CBT arm and 1·9 (95% CI 0·1 to 3·7) points lower (p=0·036) in the Web WCBT arm. A clinically significant IBS-SSS change (≧50 points), baseline to 24 months, occurred in 84/119 (70·6%) of participants in the Telephone CBT arm , 62/99 (62·6%) in the Web CBT arm and 48/105 (45·7%) in the treatment as usual arm. There were no adverse no adverse events related to treatment. Interpretation: at 24 month follow-up, sustained improvements in IBS were seen in both cognitive behavioural therapy arms compared to treatment as usual, though some previous gains were reduced compared to the 12 month outcomes. IBS-specific CBT has the potential to provide significant long-term improvement in IBS, achievable within a usual clinical setting. Increasing access to CBT for IBS could achieve long-term patient benefit. Funding: UK National Institute for Health Research, trials number ISRCTN44427879
2468-1253
863-872
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, Kim
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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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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, Kim
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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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Everitt, Hazel, Landau, Sabine, O’Reilly, Gilly, Sibelli, Alice, Hughes, Stephanie, Windgassen, Sula, Holland, Rachel, Little, Paul, McCrone, Paul, Bishop, Felicity, Goldsmith, Kim, Coleman, Nicholas, Logan, Robert, Chalder, Trudie and Moss-Morris, Rona (2019) Cognitive behavioural therapy (CBT) for irritable bowel syndrome (IBS): 24 month follow-up of ACTIB trial participants. The Lancet Gastroenterology & Hepatology, 4 (11), 863-872. (doi:10.1016/S2468-1253(19)30243-2).

Record type: Article

Abstract

Background: IBS is common, affecting 10-20% of the adult population with many people experiencing ongoing symptoms despite first line therapies. Cognitive behavioural therapy (CBT) is recommended in guidelines for refractory IBS but there is limited access to CBT for IBS and uncertainty whether benefits last in the longer term. ACTIB (Assessing Cognitive behavioural Therapy for IBS) was a large randomised controlled trial of two forms of CBT for patients with refractory IBS. ACTIB results showed, at 12 months, that both forms of CBT for IBS were significantly more effective than treatment as usual (TAU) at reducing IBS symptom severity and impact at 12 months in adults with refractory IBS. This follow-up study aims to evaluate 24 month clinical outcomes of participants recruited to the ACTIB trial. Methods: in the ACTIB three-arm randomised controlled trial, 558 adults with refractory IBS were randomly allocated to therapist-delivered telephone CBT (TCBT), web-based CBT with minimal therapist support (WCBT) or treatment as usual (TAU) and followed up for 12 months. 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 1st May 2014 and 31st March 2016. Primary outcome measures were IBS Symptom Severity Score (IBS-SSS) and Work and Social Adjustment Scale (WSAS) Intention-to-treat (ITT) analyses with multiple imputation were undertaken. This study was a non-pre-specified naturalistic follow-up and analysis of ACTIB trial participants at 24 months. Findings: 24 months follow-up of outcomes was achieved for 57·9% (323/558) participants, (119/186 in the Telephone CBT arm, 99/185 in the Web CBT arm, 105 /187 in the treatment as usual arm). At 24 months compared to treatment as usual: IBS-SSS was 40·5 (95% CI 15·0 to 66·0) points lower (p=0·002) in the Telephone CBT arm and 12·9 (95% CI -12·9 to 38·8) points lower (p=0·325) in the Web CBT arm. WSAS was 3·1 (95% CI 1·3 to 4·9) points lower (p<0·001) in the Telephone CBT arm and 1·9 (95% CI 0·1 to 3·7) points lower (p=0·036) in the Web WCBT arm. A clinically significant IBS-SSS change (≧50 points), baseline to 24 months, occurred in 84/119 (70·6%) of participants in the Telephone CBT arm , 62/99 (62·6%) in the Web CBT arm and 48/105 (45·7%) in the treatment as usual arm. There were no adverse no adverse events related to treatment. Interpretation: at 24 month follow-up, sustained improvements in IBS were seen in both cognitive behavioural therapy arms compared to treatment as usual, though some previous gains were reduced compared to the 12 month outcomes. IBS-specific CBT has the potential to provide significant long-term improvement in IBS, achievable within a usual clinical setting. Increasing access to CBT for IBS could achieve long-term patient benefit. Funding: UK National Institute for Health Research, trials number ISRCTN44427879

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ACTIB 24 month outcomes paper Lancet Gastro 100719 clean copy - Accepted Manuscript
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Accepted/In Press date: 18 July 2019
e-pub ahead of print date: 3 September 2019
Published date: November 2019

Identifiers

Local EPrints ID: 432679
URI: http://eprints.soton.ac.uk/id/eprint/432679
ISSN: 2468-1253
PURE UUID: eb3d707d-5019-44b7-9b6b-e1851707ee08
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: 24 Jul 2019 16:30
Last modified: 08 Oct 2020 04:22

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Contributors

Author: Hazel Everitt ORCID iD
Author: Sabine Landau
Author: Gilly O’Reilly
Author: Alice Sibelli
Author: Stephanie Hughes
Author: Sula Windgassen
Author: Rachel Holland
Author: Paul Little
Author: Paul McCrone
Author: Felicity Bishop ORCID iD
Author: Kim Goldsmith
Author: Nicholas Coleman
Author: Robert Logan
Author: Trudie Chalder
Author: Rona Moss-Morris

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