ACTIB (Assessing Cognitive behavioural Therapy in Irritable Bowel): A randomized controlled trial of clinical and cost effectiveness of therapist delivered cognitive behavioural therapy and web-based self-management in irritable bowel syndrome.
A 495-patient trial is testing whether a six-session telephone therapy or a website with minimal therapist support can relieve the debilitating gut symptoms that standard drugs fail to control in irritable bowel syndrome. Around one in five IBS patients has refractory disease—symptoms that persist for more than a year despite antispasmodics or antidepressants. The UK’s health watchdog recommends cognitive behavioural therapy for these patients, but face-to-face CBT is expensive and scarce. This trial directly compares two cheaper formats: therapist-led telephone CBT (eight sessions plus boosters) and a lower-intensity web-based programme (eight online sessions with three short phone calls). Both are built on a validated cognitive-behavioural model of IBS that targets bowel habits, eating patterns, unhelpful thoughts, and stress. If either approach proves clinically and cost-effective, the NHS could offer a scalable, centralised service that reaches patients at home. That would shift IBS management from repeated GP visits and drug prescriptions toward a structured psychological treatment that addresses the brain–gut link directly. The trial also includes a qualitative study of why patients stick with or abandon these therapies, which could refine future digital health tools.
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Design: A 3-arm multi-centre RCT. 495 patients with refractory IBS individually randomised to Therapist CBT (TCBT), low intensity behavioural therapy (LIBT) or TAU by an independent randomisation service (CTU) with block randomisation and stratification by centre. Assessors blind to treatment arm. TAU participants will have access to the WCBT website at trial end. A nested qualitative study will explore patients’ experiences of treatments: interviews at 3 and 12 mths with approx. 17 per arm; analysed inductively to identify factors that facilitate or impede adherence to treatment. Setting: Treatment at home via telephone and internet. Therapists based at King’s College London. Target population: Adults (18 yrs or over) with refractory IBS (on-going symptoms, IBS-SSS >75), fulfilling ROME III criteria and unresponsive to first-line therapies (eg anti-spasmodics or anti-depressants) with a continuing symptom profile >12 months. Exclusion: unexplained rectal bleeding or weight loss, IBD, coeliac disease, colorectal carcinoma. Blood tests: FBC, TTG, CRP taken prior to randomisation to exclude important differential diagnoses. Current medications maintained at a stable dose. Recording of: current and past medications, length of symptoms, sub-type of IBS (diarrhoea, constipation or alternating pattern), previous or current psychiatric diagnoses. Health Technologies being assessed: Therapist CBT and Lower intensity CBT (a web-based self-management programme). NICE recommends CBT for refractory IBS but cost is high and availability poor. We will compare 2 formats of CBT (TCBT and LIBT) for IBS against TAU in a high quality trial. The CBT is based on an empirical CB model of IBS (Spence, Moss-Morris. GUT 56,(8),2007). Key differences between arms: therapist contact time and interactive website access. Structured therapy sessions, based on a previous efficacious CBT trial for IBS, consist of education, behavioural and cognitive techniques, aimed at improving bowel habits, developing stable, healthy eating patterns, addressing unhelpful thoughts, managing stress, reducing symptom focussing and preventing relapse. TCBT: patient manual + 6, 60min telephone sessions + homework tasks with a CBT therapist at week 1, 2, 3, 5, 7, 9 and two 1 hr 'booster' CBT sessions at 4 and 8mths. WCBT: An interactive, tailored CBT self-management website developed with substantial patient input (MIBS trial). Participants access 8 online sessions and homework tasks, similar content to TCBT and receive weekly automated email reminders and minimal therapist support: 3, 30 minute telephone support calls at week 1, 3 and 5 and two, 30 min booster sessions at 4 and 8mths. ‘Booster’ sessions are included in both arms to discuss setbacks and to reinforce positive symptom management. Telephone CBT sessions rather than face to face are proposed, as they have similar efficacy, improve accessibility, are efficient, less costly and could be readily delivered across the NHS from a centralised service. Currently, IBS patients have minimal CBT access. Web CBT is effective in depression and recent small trials show promise for IBS but indicate some therapist input is needed. 73% households have internet connections with numbers rising. Therapists receive manuals, training and supervision to ensure quality and adherence to protocol. All sessions are taped to check treatment fidelity, length and number of phone sessions. Patients’ adherence is measured through number of phone sessions and automated count of web sessions accessed. Secure website passwording will ensure non-contamination of treatments. TAU is defined as continuation of current medications, and GP or consultant follow-up with no psychological therapy. All participants receive a standard information sheet on Lifestyle and Diet in IBS based on NICE. Measurement of cost and outcomes: Primary outcomes: IBS symptom Severity Scale (IBS-SSS) and Work and Social adjustment scale (WSAS). IBS SSS is widely used in IBS
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