Project overview
The
aim of this NIHR HTA
funded multicentre RCT was to determine the clinical and cost effectiveness of
therapist telephone
delivered cognitive behavioural therapy and web based CBT self-management in
irritable bowel syndrome.
IBS affects 10–22% of the UK population, with NHS costs over £200 million a
year. Abdominal pain, bloating and altered bowel habit affect quality of life,
social functioning and time off work. GP management of IBS involves a positive diagnosis,
reassurance, lifestyle advice and drug therapies, but many patients suffer ongoing
symptoms. CBT and supporting
self-management were known
to be helpful, but poor availability in the NHS has limited the use of CBT for IBS. This trial has provided evidence on the
clinical and cost effectiveness of therapist telephone delivered and web-based CBT for IBS to improve service planning and access to
treatment for people with IBS.
558 participants with refractory IBS were recruited from primary and secondary
care in London and Southampton and randomised to a high intensity therapist
delivered CBT (TCBT) + Treatment as usual (TAU), or a lower intensity web based
CBT programme (WCBT) + TAU or Treatment as usual alone.
The two CBT programmes included the same content.
TCBT consisted of six, 60 minute CBT sessions with a therapist over the
telephone completed over 9 weeks at home and two ‘booster’ one hour follow up
phone calls at 4 and 8 months (8 hours therapist contact time).
WCBT consisted of access to a previously developed and piloted web based CBT
self-management programme (Regul8) and three 30 minute therapist telephone
sessions completed over 9 weeks at home and two ‘booster’ 30 minute follow up
phone calls at 4 and 8 months (2½ hours therapist contact time).
Clinical effectiveness was
assessed by examining the difference between the 3 trial arms in the IBS Symptom severity score
(IBS SSS) and the Work and Social Adjustment Scale (WASAS) which measures
participants ability to function and live their lives at 12 months from
randomisation. Cost effectiveness combined measures of resource use with the IBS SSS at 12
months and Quality Adjusted Life Years (QALYs).
The ACTIB trial results
showed that both telephone and web based CBT for IBS significantly improved IBS
symptoms at 12 months. The 12 and 24 month trial results were published in
2019, and the health economic analysis in 2021 (see links to papers below)
The ACTIB Therapist and Patient
CBT for IBS manuals were made freely available to the NHS Improving Access to
Psychological Therapy service
The Web based CBT for IBS
intervention (REGUL8) was Approved for assessment in practice by NICE in 2020
and Mahana Therapeutics obtained
FDA Marketing Authorization for the First Prescription Digital Therapeutic to
Treat Irritable Bowel Syndrome in 2020.
The ACTIB trial results
were incorporated into the British Society of Gastroenterology
guidelines on the management of irritable bowel syndrome April 2021. (See the Research outputs below.)
The results of this rigorous conducted study
with long-term follow up
enable clinicians, patients and health service planners to make informed
decisions regarding the management of IBS with CBT.
Trial Registration ISRCTN
Funders Number: 11/69/02
The ACTIB Trial
commenced in September 2013 and was completed in 2018.
Contact for the study: Professor
Hazel Everitt
University of Southampton
Staff
Professor Hazel Everitt (Chief Investigator)
Professor Paul Little (Expert on complex trial
management & recruitment)
Dr Gilly O’Reilly (Trial Manager)
Professor Flis Bishop (Responsibility for Qualitative
Interviews)
Mrs Steph Hughes (Research Assistant)
Co-Investigators
at other Institutions
Professor Rona Moss-Morris, Professor in
Psychology
Professor Trudie Chalder, Professor of Cognitive
Behavioural Psychotherapy
Professor Sabine Landau, Professor of
Biostatistics
Professor Paul McCrone, Professor of Health
Economics
Dr Robert Logan, Consultant
Gastroenterologist, Kings College London
Dr Nick Coleman, Collaborator at UHS Southampton
