Therapist telephone-delivered CBT and web-based CBT compared with treatment as usual in refractory irritable bowel syndrome: the ACTIB three-arm RCT

Hazel Everitt; Sabine Landau; Paul Little; Felicity Bishop; Gilly O'Reilly; Alice Sibelli; Rachel Mary Holland; S. Hughes; Sula Sumati Windgassen; Paul Richard McCrone; Kimberley Ann Goldsmith; N Coleman; Robert Logan; Trudie Chalder; Rona Moss-Morris

doi:10.3310/hta23170

Therapist telephone-delivered CBT and web-based CBT compared with treatment as usual in refractory irritable bowel syndrome: the ACTIB three-arm RCT

Hazel Everitt, Sabine Landau, Paul Little, Felicity Bishop, Gilly O'Reilly, Alice Sibelli, Rachel Mary Holland, S. Hughes, Sula Sumati Windgassen, Paul Richard McCrone, Kimberley Ann Goldsmith, N Coleman, Robert Logan, Trudie Chalder, Rona Moss-Morris

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Abstract

Abstract Background Irritable bowel syndrome (IBS) affects 10–22% of people in the UK. Abdominal pain, bloating and altered bowel habits affect quality of life and can lead to time off work. Current treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many people suffer ongoing symptoms. Cognitive–behavioural therapy (CBT) is recommended in guidelines for patients with ongoing symptoms but its availability is limited. Objectives To determine the clinical effectiveness and cost-effectiveness of therapist telephone-delivered CBT (TCBT) and web-based CBT (WCBT) with minimal therapist support compared with treatment as usual (TAU) in refractory IBS. Design This was a three-arm randomised controlled trial. Setting This trial took place in UK primary and secondary care. Participants Adults with refractory IBS (clinically significant symptoms for 12 months despite first-line therapies) were recruited from 74 general practices and three gastroenterology centres from May 2014 to March 2016. Interventions TCBT – patient CBT self-management manual, six 60-minute telephone sessions over 9 weeks and two 60-minute booster sessions at 4 and 8 months (8 hours’ therapist time). WCBT – interactive, tailored web-based CBT, three 30-minute telephone sessions over 9 weeks and two 30-minute boosters at 4 and 8 months (2.5 hours’ therapist time). Main outcome measures Primary outcomes – IBS symptom severity score (IBS SSS) and Work and Social Adjustment Scale (WSAS) at 12 months. Cost-effectiveness [quality-adjusted life-years (QALYs) and health-care costs]. Results In total, 558 out of 1452 patients (38.4%) screened for eligibility were recruited – 186 were randomised to TCBT, 185 were randomised to WCBT and 187 were randomised to TAU. The mean baseline Irritable Bowel Syndrome Symptom Severity Score (IBS SSS) was 265.0. An intention-to-treat analysis with multiple imputation was carried out at 12 months; IBS SSS were 61.6 points lower in the TCBT arm [95% confidence interval (CI) 89.5 to 33.8; p < 0.001] and 35.2 points lower in the WCBT arm (95% CI 57.8 to 12.6; p = 0.002) than in the TAU arm (IBS SSS of 205.6). The mean WSAS score at 12 months was 10.8 in the TAU arm, 3.5 points lower in the TCBT arm (95% CI 5.1 to 1.9; p < 0.001) and 3.0 points lower in the WCBT arm (95% CI 4.6 to 1.3; p = 0.001). For the secondary outcomes, the Subject’s Global Assessment showed an improvement in symptoms at 12 months (responders) in 84.8% of the TCBT arm compared with 41.7% of the TAU arm [odds ratio (OR) 6.1, 95% CI 2.5 to 15.0; p < 0.001] and 75.0% of the WCBT arm (OR 3.6, 95% CI 2.0 to 6.3; p < 0.001). Patient enablement was 78.3% (responders) for TCBT, 23.5% for TAU (OR 9.3, 95% CI 4.5 to 19.3; p < 0.001) and 54.8% for WCBT (OR 3.5, 95% CI 2.0 to 5.9; p < 0.001). Adverse events were similar between the trial arms. The incremental cost-effectiveness ratio (ICER) (QALY) for TCBT versus TAU was £22,284 and for WCBT versus TAU was £7724. Cost-effectiveness reduced after imputation for missing values. Qualitative findings highlighted that, in the CBT arms, there was increased capacity to cope with symptoms, negative emotions and challenges of daily life. Therapist input was important in supporting WCBT. Conclusions In this large, rigorously conducted RCT, both CBT arms showed significant improvements in IBS outcomes compared with TAU. WCBT had lower costs per QALY than TCBT. Sustained improvements in IBS symptoms are possible at an acceptable cost. Suggested future research work is longer-term follow-up and research to translate these findings into usual clinical practice. Future work Longer-term follow-up and research to translate these findings into usual clinical practice is needed.

Original language	English
Pages (from-to)	1-154
Number of pages	154
Journal	Health Technology Assessment
Volume	23
Issue number	17
Early online date	15 Apr 2019
DOIs	https://doi.org/10.3310/hta23170
Publication status	Published - 1 May 2019

Keywords

COGNITIVE–BEHAVIOURAL THERAPY
DIGITAL INTERVENTION
IRRITABLE BOWEL SYNDROME
RANDOMISED CONTROLLED TRIAL
SELF-MANAGEMENT

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Everitt, H., Landau, S., Little, P., Bishop, F., O'Reilly, G., Sibelli, A., Holland, R. M., Hughes, S., Windgassen, S. S., McCrone, P. R., Goldsmith, K. A., Coleman, N., Logan, R., Chalder, T., & Moss-Morris, R. (2019). Therapist telephone-delivered CBT and web-based CBT compared with treatment as usual in refractory irritable bowel syndrome: the ACTIB three-arm RCT. Health Technology Assessment, 23(17), 1-154. https://doi.org/10.3310/hta23170

@article{622f3fe0764146d4a46d90d0de420d1a,

title = "Therapist telephone-delivered CBT and web-based CBT compared with treatment as usual in refractory irritable bowel syndrome: the ACTIB three-arm RCT",

abstract = "Abstract Background Irritable bowel syndrome (IBS) affects 10–22% of people in the UK. Abdominal pain, bloating and altered bowel habits affect quality of life and can lead to time off work. Current treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many people suffer ongoing symptoms. Cognitive–behavioural therapy (CBT) is recommended in guidelines for patients with ongoing symptoms but its availability is limited. Objectives To determine the clinical effectiveness and cost-effectiveness of therapist telephone-delivered CBT (TCBT) and web-based CBT (WCBT) with minimal therapist support compared with treatment as usual (TAU) in refractory IBS. Design This was a three-arm randomised controlled trial. Setting This trial took place in UK primary and secondary care. Participants Adults with refractory IBS (clinically significant symptoms for 12 months despite first-line therapies) were recruited from 74 general practices and three gastroenterology centres from May 2014 to March 2016. Interventions TCBT – patient CBT self-management manual, six 60-minute telephone sessions over 9 weeks and two 60-minute booster sessions at 4 and 8 months (8 hours{\textquoteright} therapist time). WCBT – interactive, tailored web-based CBT, three 30-minute telephone sessions over 9 weeks and two 30-minute boosters at 4 and 8 months (2.5 hours{\textquoteright} therapist time). Main outcome measures Primary outcomes – IBS symptom severity score (IBS SSS) and Work and Social Adjustment Scale (WSAS) at 12 months. Cost-effectiveness [quality-adjusted life-years (QALYs) and health-care costs]. Results In total, 558 out of 1452 patients (38.4%) screened for eligibility were recruited – 186 were randomised to TCBT, 185 were randomised to WCBT and 187 were randomised to TAU. The mean baseline Irritable Bowel Syndrome Symptom Severity Score (IBS SSS) was 265.0. An intention-to-treat analysis with multiple imputation was carried out at 12 months; IBS SSS were 61.6 points lower in the TCBT arm [95% confidence interval (CI) 89.5 to 33.8; p < 0.001] and 35.2 points lower in the WCBT arm (95% CI 57.8 to 12.6; p = 0.002) than in the TAU arm (IBS SSS of 205.6). The mean WSAS score at 12 months was 10.8 in the TAU arm, 3.5 points lower in the TCBT arm (95% CI 5.1 to 1.9; p < 0.001) and 3.0 points lower in the WCBT arm (95% CI 4.6 to 1.3; p = 0.001). For the secondary outcomes, the Subject{\textquoteright}s Global Assessment showed an improvement in symptoms at 12 months (responders) in 84.8% of the TCBT arm compared with 41.7% of the TAU arm [odds ratio (OR) 6.1, 95% CI 2.5 to 15.0; p < 0.001] and 75.0% of the WCBT arm (OR 3.6, 95% CI 2.0 to 6.3; p < 0.001). Patient enablement was 78.3% (responders) for TCBT, 23.5% for TAU (OR 9.3, 95% CI 4.5 to 19.3; p < 0.001) and 54.8% for WCBT (OR 3.5, 95% CI 2.0 to 5.9; p < 0.001). Adverse events were similar between the trial arms. The incremental cost-effectiveness ratio (ICER) (QALY) for TCBT versus TAU was £22,284 and for WCBT versus TAU was £7724. Cost-effectiveness reduced after imputation for missing values. Qualitative findings highlighted that, in the CBT arms, there was increased capacity to cope with symptoms, negative emotions and challenges of daily life. Therapist input was important in supporting WCBT. Conclusions In this large, rigorously conducted RCT, both CBT arms showed significant improvements in IBS outcomes compared with TAU. WCBT had lower costs per QALY than TCBT. Sustained improvements in IBS symptoms are possible at an acceptable cost. Suggested future research work is longer-term follow-up and research to translate these findings into usual clinical practice. Future work Longer-term follow-up and research to translate these findings into usual clinical practice is needed.",

keywords = "COGNITIVE–BEHAVIOURAL THERAPY, DIGITAL INTERVENTION, IRRITABLE BOWEL SYNDROME, RANDOMISED CONTROLLED TRIAL, SELF-MANAGEMENT",

author = "Hazel Everitt and Sabine Landau and Paul Little and Felicity Bishop and Gilly O'Reilly and Alice Sibelli and Holland, {Rachel Mary} and S. Hughes and Windgassen, {Sula Sumati} and McCrone, {Paul Richard} and Goldsmith, {Kimberley Ann} and N Coleman and Robert Logan and Trudie Chalder and Rona Moss-Morris",

year = "2019",

month = may,

day = "1",

doi = "10.3310/hta23170",

language = "English",

volume = "23",

pages = "1--154",

journal = "Health Technology Assessment",

issn = "1366-5278",

publisher = "NIHR Health Technology Assessment Programme",

number = "17",

}

Everitt, H, Landau, S, Little, P, Bishop, F, O'Reilly, G, Sibelli, A , Holland, RM, Hughes, S, Windgassen, SS , McCrone, PR , Goldsmith, KA, Coleman, N, Logan, R, Chalder, T & Moss-Morris, R 2019, 'Therapist telephone-delivered CBT and web-based CBT compared with treatment as usual in refractory irritable bowel syndrome: the ACTIB three-arm RCT', Health Technology Assessment, vol. 23, no. 17, pp. 1-154. https://doi.org/10.3310/hta23170

TY - JOUR

T1 - Therapist telephone-delivered CBT and web-based CBT compared with treatment as usual in refractory irritable bowel syndrome: the ACTIB three-arm RCT

AU - Everitt, Hazel

AU - Landau, Sabine

AU - Little, Paul

AU - Bishop, Felicity

AU - O'Reilly, Gilly

AU - Sibelli, Alice

AU - Holland, Rachel Mary

AU - Hughes, S.

AU - Windgassen, Sula Sumati

AU - McCrone, Paul Richard

AU - Goldsmith, Kimberley Ann

AU - Coleman, N

AU - Logan, Robert

AU - Chalder, Trudie

AU - Moss-Morris, Rona

PY - 2019/5/1

Y1 - 2019/5/1

N2 - Abstract Background Irritable bowel syndrome (IBS) affects 10–22% of people in the UK. Abdominal pain, bloating and altered bowel habits affect quality of life and can lead to time off work. Current treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many people suffer ongoing symptoms. Cognitive–behavioural therapy (CBT) is recommended in guidelines for patients with ongoing symptoms but its availability is limited. Objectives To determine the clinical effectiveness and cost-effectiveness of therapist telephone-delivered CBT (TCBT) and web-based CBT (WCBT) with minimal therapist support compared with treatment as usual (TAU) in refractory IBS. Design This was a three-arm randomised controlled trial. Setting This trial took place in UK primary and secondary care. Participants Adults with refractory IBS (clinically significant symptoms for 12 months despite first-line therapies) were recruited from 74 general practices and three gastroenterology centres from May 2014 to March 2016. Interventions TCBT – patient CBT self-management manual, six 60-minute telephone sessions over 9 weeks and two 60-minute booster sessions at 4 and 8 months (8 hours’ therapist time). WCBT – interactive, tailored web-based CBT, three 30-minute telephone sessions over 9 weeks and two 30-minute boosters at 4 and 8 months (2.5 hours’ therapist time). Main outcome measures Primary outcomes – IBS symptom severity score (IBS SSS) and Work and Social Adjustment Scale (WSAS) at 12 months. Cost-effectiveness [quality-adjusted life-years (QALYs) and health-care costs]. Results In total, 558 out of 1452 patients (38.4%) screened for eligibility were recruited – 186 were randomised to TCBT, 185 were randomised to WCBT and 187 were randomised to TAU. The mean baseline Irritable Bowel Syndrome Symptom Severity Score (IBS SSS) was 265.0. An intention-to-treat analysis with multiple imputation was carried out at 12 months; IBS SSS were 61.6 points lower in the TCBT arm [95% confidence interval (CI) 89.5 to 33.8; p < 0.001] and 35.2 points lower in the WCBT arm (95% CI 57.8 to 12.6; p = 0.002) than in the TAU arm (IBS SSS of 205.6). The mean WSAS score at 12 months was 10.8 in the TAU arm, 3.5 points lower in the TCBT arm (95% CI 5.1 to 1.9; p < 0.001) and 3.0 points lower in the WCBT arm (95% CI 4.6 to 1.3; p = 0.001). For the secondary outcomes, the Subject’s Global Assessment showed an improvement in symptoms at 12 months (responders) in 84.8% of the TCBT arm compared with 41.7% of the TAU arm [odds ratio (OR) 6.1, 95% CI 2.5 to 15.0; p < 0.001] and 75.0% of the WCBT arm (OR 3.6, 95% CI 2.0 to 6.3; p < 0.001). Patient enablement was 78.3% (responders) for TCBT, 23.5% for TAU (OR 9.3, 95% CI 4.5 to 19.3; p < 0.001) and 54.8% for WCBT (OR 3.5, 95% CI 2.0 to 5.9; p < 0.001). Adverse events were similar between the trial arms. The incremental cost-effectiveness ratio (ICER) (QALY) for TCBT versus TAU was £22,284 and for WCBT versus TAU was £7724. Cost-effectiveness reduced after imputation for missing values. Qualitative findings highlighted that, in the CBT arms, there was increased capacity to cope with symptoms, negative emotions and challenges of daily life. Therapist input was important in supporting WCBT. Conclusions In this large, rigorously conducted RCT, both CBT arms showed significant improvements in IBS outcomes compared with TAU. WCBT had lower costs per QALY than TCBT. Sustained improvements in IBS symptoms are possible at an acceptable cost. Suggested future research work is longer-term follow-up and research to translate these findings into usual clinical practice. Future work Longer-term follow-up and research to translate these findings into usual clinical practice is needed.

AB - Abstract Background Irritable bowel syndrome (IBS) affects 10–22% of people in the UK. Abdominal pain, bloating and altered bowel habits affect quality of life and can lead to time off work. Current treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many people suffer ongoing symptoms. Cognitive–behavioural therapy (CBT) is recommended in guidelines for patients with ongoing symptoms but its availability is limited. Objectives To determine the clinical effectiveness and cost-effectiveness of therapist telephone-delivered CBT (TCBT) and web-based CBT (WCBT) with minimal therapist support compared with treatment as usual (TAU) in refractory IBS. Design This was a three-arm randomised controlled trial. Setting This trial took place in UK primary and secondary care. Participants Adults with refractory IBS (clinically significant symptoms for 12 months despite first-line therapies) were recruited from 74 general practices and three gastroenterology centres from May 2014 to March 2016. Interventions TCBT – patient CBT self-management manual, six 60-minute telephone sessions over 9 weeks and two 60-minute booster sessions at 4 and 8 months (8 hours’ therapist time). WCBT – interactive, tailored web-based CBT, three 30-minute telephone sessions over 9 weeks and two 30-minute boosters at 4 and 8 months (2.5 hours’ therapist time). Main outcome measures Primary outcomes – IBS symptom severity score (IBS SSS) and Work and Social Adjustment Scale (WSAS) at 12 months. Cost-effectiveness [quality-adjusted life-years (QALYs) and health-care costs]. Results In total, 558 out of 1452 patients (38.4%) screened for eligibility were recruited – 186 were randomised to TCBT, 185 were randomised to WCBT and 187 were randomised to TAU. The mean baseline Irritable Bowel Syndrome Symptom Severity Score (IBS SSS) was 265.0. An intention-to-treat analysis with multiple imputation was carried out at 12 months; IBS SSS were 61.6 points lower in the TCBT arm [95% confidence interval (CI) 89.5 to 33.8; p < 0.001] and 35.2 points lower in the WCBT arm (95% CI 57.8 to 12.6; p = 0.002) than in the TAU arm (IBS SSS of 205.6). The mean WSAS score at 12 months was 10.8 in the TAU arm, 3.5 points lower in the TCBT arm (95% CI 5.1 to 1.9; p < 0.001) and 3.0 points lower in the WCBT arm (95% CI 4.6 to 1.3; p = 0.001). For the secondary outcomes, the Subject’s Global Assessment showed an improvement in symptoms at 12 months (responders) in 84.8% of the TCBT arm compared with 41.7% of the TAU arm [odds ratio (OR) 6.1, 95% CI 2.5 to 15.0; p < 0.001] and 75.0% of the WCBT arm (OR 3.6, 95% CI 2.0 to 6.3; p < 0.001). Patient enablement was 78.3% (responders) for TCBT, 23.5% for TAU (OR 9.3, 95% CI 4.5 to 19.3; p < 0.001) and 54.8% for WCBT (OR 3.5, 95% CI 2.0 to 5.9; p < 0.001). Adverse events were similar between the trial arms. The incremental cost-effectiveness ratio (ICER) (QALY) for TCBT versus TAU was £22,284 and for WCBT versus TAU was £7724. Cost-effectiveness reduced after imputation for missing values. Qualitative findings highlighted that, in the CBT arms, there was increased capacity to cope with symptoms, negative emotions and challenges of daily life. Therapist input was important in supporting WCBT. Conclusions In this large, rigorously conducted RCT, both CBT arms showed significant improvements in IBS outcomes compared with TAU. WCBT had lower costs per QALY than TCBT. Sustained improvements in IBS symptoms are possible at an acceptable cost. Suggested future research work is longer-term follow-up and research to translate these findings into usual clinical practice. Future work Longer-term follow-up and research to translate these findings into usual clinical practice is needed.

KW - COGNITIVE–BEHAVIOURAL THERAPY

KW - DIGITAL INTERVENTION

KW - IRRITABLE BOWEL SYNDROME

KW - RANDOMISED CONTROLLED TRIAL

KW - SELF-MANAGEMENT

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DO - 10.3310/hta23170

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JO - Health Technology Assessment

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IS - 17

ER -

Therapist telephone-delivered CBT and web-based CBT compared with treatment as usual in refractory irritable bowel syndrome: the ACTIB three-arm RCT

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