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.
- irritable bowel syndrome
- cognitive-behavioural therapy
- randomised controlled trial
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TC and RM-M contributed equally.
Contributors The principal investigators (HAE, RMM and TC) and the other coapplicants (PMC, PL, SL, FB, RL, NC) designed the study and obtained funding. The protocol was further developed by the Trial Management Group (TMG) and agreed by the Trial Steering Committee (TSC) and Data Monitoring and Ethics Committee (DMEC). The TMG, chaired by HAE, included all the authors of this paper and Jill Durnell and Kate Riley, the PPI representatives. The statistical analysis plan (SAP) was developed by KG, RH and SL, discussed by the TMG and DMEC and approved by the TSC before database lock. RH and SL carried out the main statistical analyses. The Regul8 website was previously developed in the MIBS NIHR RfPB funded study and was managed and updated for this study by SH and AS. TC and RMM developed the therapy protocols and treatment manuals, and trained and supervised the trial therapists. RMM led the website arm and TC the therapist arm. The CBT therapists were Suzanne Roche, Mary Burgess, Barbara Bowman, Natalia Fainblum, Fabio Simao, David McCormack, Caroline Stokes, Antonia Dittner, Claire Willis and Jerome Tierney. Independent assessors of therapy fidelity were Alison Griffiths and Sarah Lack. The chief investigator was HAE and the trial manager was GOR. SH, AS and SW were the research assistants. HAE led the primary care recruitment. NC and RL were clinic expert advisors and led the secondary care recruitment at Southampton and London, respectively. All authors contributed to this manuscript and approved it prior to submission. All named authors commented on drafts and approved the final report. Members of the writing group had responsibility for submitting the report, and HAE had the final responsibility for the decision to submit for publication.
Funding The project ACTIB (Assessing Cognitive–behavioural Therapy in Irritable Bowel syndrome)—a randomised controlled trial of clinical and cost-effectiveness of therapist-delivered cognitive–behavioural therapy and web-based self-management in irritable bowel syndrome—was funded by the National Institute for Health Research (NIHR) HTA Project: 11/69/02, with additional support from the NIHR Clinical Research Network. This paper represents independent research with some staff part funded by the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King’s College London.
Disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.
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.
Ethics approval NRES Committee South Central, Berkshire, June 2013 (13/SC/0206).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The lead author (HAE) can be contacted regarding data sharing requests.
Collaborators ACTIB trial group: Trial Steering Committee (independent members): Peter White (chair), Else Guthrie, Qasim Aziz and Tom Sensky. Data Monitoring and Ethics Committee (DMEC) (independent members): Astrid Fletcher (chair), Charlotte Feinmann and Ronan O’Carroll. Patient and public involvement (PPI) member on TSC and DMEC: Jill Durnell. Trial management group PPI member: Kate Riley.
Patient consent for publication Not required.
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