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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

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.

1468-3288
1613-1623
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
a6d39500-67ff-4d7a-a1dc-8e42f80945ff
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
f7742d57-6646-4ce0-bbc0-60e2da09b01b
Logan, Robert
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Chalder, Trudie
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Moss-Morris, Rona
a502f58a-d319-49a6-8aea-9dde4efc871e
Everitt, Hazel
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Landau, Sabine
d708d4cc-a2be-4abd-94e9-d80365127567
O'reilly, Gilly
f66a0310-7e33-4ca7-bb85-8e7a0e780a5d
Sibelli, Alice
64b9c97c-3cf9-4915-8af0-c40b7805a8f1
Hughes, Stephanie
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Windgassen, Sula
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Holland, Rachel
db9576a1-59b0-40af-ad27-c8248341b470
Little, Paul
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McCrone, Paul
ce0c78b3-8fba-43ff-b305-e331c00cb9f9
Bishop, Felicity
1f5429c5-325f-4ac4-aae3-6ba85d079928
Goldsmith, Kimberley
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Coleman, Nicholas
f7742d57-6646-4ce0-bbc0-60e2da09b01b
Logan, Robert
b557d144-df24-4015-87fc-822319bc3f37
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, 68 (9), 1613-1623. (doi:10.1136/gutjnl-2018-317805).

Record type: Article

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.

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

Identifiers

Local EPrints ID: 429733
URI: http://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 Stephanie Hughes: ORCID iD orcid.org/0000-0003-4801-8245
ORCID for Paul Little: ORCID iD orcid.org/0000-0003-3664-1873
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: 12 Jul 2024 01:49

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Contributors

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

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