Case study: Remotely delivered CBT alleviates symptoms and reduces impact of IBS on patients’ lives
IBS - limited treatment options
Many people who live with irritable bowel syndrome (IBS) have to plan their day-to-day lives around the symptoms caused by their condition. Abdominal pain, bloating, diarrhoea and constipation are the most commonly reported symptoms of IBS, and the condition is linked with higher levels of anxiety and depression. Concerns surrounding their condition, such as the foods they can eat and access to toilets, can affect people’s ability to work and socialise and impact on their overall quality of life.
IBS is a common condition, affecting up to 20% of people in the UK, but it can be difficult to treat successfully and costs the NHS over £200 million per year. Following a diagnosis of IBS, patients are given advice about making positive changes to their lifestyle (such as diet and exercise) and prescribed medication to improve their symptoms.
Despite treatment, many patients continue to suffer from ongoing symptoms (referred to as refractory IBS). An additional option is a psychological approach called cognitive behavioural therapy (CBT). It is recommended by NICE guidelines for patients with IBS who continue to have symptoms after 12 months of treatment with other therapies.
However, there was previously little evidence to confirm how effective CBT is in the longer term or in a large number of patients. Additionally, patients and clinicians faced difficulty accessing the very limited number of NHS face-to-face CBT for IBS appointments.
In the largest study of its kind worldwide, a research project funded by the NIHR Health Technology Assessment Programme set out to deliver stronger evidence for the NHS to offer IBS-specific CBT to patients for whom first-line treatments and drugs have failed. The researchers particularly focused on investigating whether IBS-specific CBT could be delivered to patients via telephone or web-based therapy, which could make treatment available to many more people with IBS.
Professor Hazel Everitt, lead researcher of the Assessing Cognitive behavioural Therapy for IBS (ACTIB) study at the University of Southampton, said: “As a GP I regularly see patients who have ongoing problems with IBS symptoms that really impact on their lives.”
Despite CBT for IBS being recommended in the NICE guidelines, NHS availability was extremely limited and there was nowhere I could refer patients in the NHS for IBS-specific CBT. This motivated me to undertake this research with NIHR to try and improve access.
Professor Hazel Everitt, lead researcher for ACTIB
CBT shows lasting benefits for patients
The cause of IBS is not completely understood but scientists are aware of a link between the central nervous system and the gut nervous system. This means psychological factors, such as stress, can influence IBS symptoms. CBT focuses on modifying people’s thoughts and behaviours around their everyday activities and potentially stressful situations to help manage their IBS symptoms.
With the help of NIHR’s Clinical Research Network, the ACTIB research team recruited 558 people with long-standing IBS who experienced continued symptoms despite medication and lifestyle changes. One third of the participants received eight one-hour sessions of telephone-based therapy with therapists from the Improving Access to Psychological Therapy (IAPT) service trained in IBS-specific CBT. Patients also received a home CBT manual and their usual standard treatment.
Another third had access to a web-based therapy of eight modules of interactive, online IBS-specific CBT (Regul8) and five half-hour sessions with a therapist over the phone. The online programme had been previously developed and feasibility tested in an NIHR Research for Patient Benefit grant. Both therapies included detailed information about understanding IBS and managing unhelpful thoughts and behaviours and included sessions such as assessing and managing symptoms and stress and dealing with flares of symptoms. The remaining group received standard treatment alone, such as lifestyle advice and first-line IBS medications, such as antispasmodics.
After 12 months, patients who had received either telephone or web-based therapy reported fewer IBS symptoms, experienced lower levels of anxiety and depression and felt more able to manage work and relationships compared with those who only received standard IBS treatments. The results of the 12-month follow-up study are published in the journal GUT.
The ACTIB researchers followed up the patients for 24 months and found that the benefits of telephone and web-based CBT continued despite receiving no further therapy. Those who received the most therapist contact time appeared to benefit the most. The ACTIB 24-month study’s results have been published in The Lancet Gastroenterology and Hepatology.
Patient and public involvement (PPI) is an important element of NIHR-funded research to ensure that findings are relevant to the people who could benefit from new treatments. Jill Durnell has long-standing IBS symptoms and participated in the ACTIB trial as a PPI representative. Commenting on the impact of the trial on her health, she said:
My involvement with the ACTIB trial has made me aware of the psychological effect of my IBS. I feel that, to a great extent, I can manage the condition and I have minimised the impact of IBS on my life, without the cost of medication or medical consultations. IBS is not controlling my life.
Jill Durnell, PPI representative on the ACTIB trial
Improving access to IBS-specific CBT
Professor Everitt said: “The fact that both types of remote delivery of IBS-specific CBT were shown to be effective is really important and exciting. This has great potential to increase access to effective care and with the additional benefit that patients are able to undertake these treatments at a time convenient to them, without having to travel to clinics”.
Studies funded by the NIHR HTA Programme not only assess how effectively a treatment works for patients, but also the potential cost to the NHS to make it widely available. The ACTIB team’s evaluation of costs, published in BMC Gastroenterology, found that both web-based and telephone CBT were cost-effective compared with patients’ usual treatment, although web-based CBT was associated with the lowest costs. These cost savings were even greater when the wider cost to society and patients with IBS were considered in addition to NHS costs.
Patients are already benefitting from this research as the ACTIB trial team has helped train over 400 NHS therapists in England to deliver telephone-based therapy and made their therapist and patient manuals freely available to the NHS IAPT programme. NICE has approved Regul8, the web-based programme trialled in ACTIB, in the NICE IAPT Digital assessment exercise, which assesses evidence-based therapies that can be widely delivered digitally to help patients manage their health conditions. It is now being evaluated in clinical practice.
The results have also contributed to the updated British Society of Gastroenterology guidelines on the management of IBS, offering an evidence-based treatment framework for clinicians to apply to their practice. Professor Alexander Ford, Professor of Gastroenterology and Honorary Consultant Gastroenterologist at the University of Leeds, co-authored the guidelines, and commented:
ACTIB is a landmark trial and shows that IBS-specific CBT delivered remotely is effective in both the short- and long-term for some people with IBS. The remote aspect is particularly appealing, as face-to-face CBT is hard to deliver in IBS due to a lack of availability.
The research team has also collaborated with a commercial company, Mahana Therapeutics, who updated Regul8 for compliance with current NICE guidelines and secured Food and Drug Administration approval in the US. The programme is now being made available to patients in the US via a prescription app. They have also secured US, UK and European CE marks for the web programme.
All of these dissemination and implementation activities will improve access to IBS-specific CBT and increase benefit from this NIHR-funded research.
Professor Hazel Everitt
While considering the next steps for improving treatment for patients with IBS, Professor Ford went on to say that: “Many patients included in the ACTIB trial had refractory symptoms and would therefore be expected to have symptoms that are difficult to treat. This suggests that trials using this remote delivery CBT protocol earlier on in the diagnosis, rather than when symptoms have become refractory, should be conducted.”