The University of Southampton
Medicine

Research project: ACTIB - Assessing Cognitive behavioural Therapy in Irrital Bowel Syndrome

Currently Active: 
Yes

The aim of this multicentre RCT is to determine the clinical and cost effectiveness of therapist delivered cognitive behavioural therapy and web based CBT self-management in irritable bowel syndrome.

Project Overview

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. Current GP treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many suffer ongoing symptoms. CBT and self-management can be helpful, but poor availability in the NHS restricts its use. Further evidence on the clinical and cost effectiveness of therapist CBT for IBS and low intensity alternatives will help in service planning and provision in the NHS.

495 participants with refractory IBS will be 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 (LIBT) + TAU or Treatment as usual alone.

The two CBT programmes will include the same content.

TCBT will consist 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).
LIBT will consist 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 will be assessed by examining the difference between 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 will combine measures of resource use with the IBS SSS at 12 months and QALYs.

This trial will assess the clinical and cost effectiveness of CBT for IBS in a well designed rigorous study with a long term outcome. This will enable clinicians, patients and health service planners to make informed decisions regarding the management of IBS with CBT.

Funding: This study was funded by a grant from the NIHR Health Technology Assessment Programme, UK.
Trial Registration ISRCTN
Funders Number: 11/69/02

The project commenced in September 2013. Results of the trial are likely to be published in 2018.

Contact for the study: Gilly O'Reilly - gor@soton.ac.uk

University of Southampton Staff
Dr Hazel Everitt (Chief Investigator)
Professor Paul Little (Expert on complex trial management & recruitment)
Gilly O’Reilly (Trial Manager)
Dr Flis Bishop (Responsibility for Qualitative Interviews)
Ms Steph Hughes (Research Assistant)

Robert Logan, Consultant Gastroenterologist, Kings College London
Nick Coleman, Collaborator at UHS Southampton

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


HTA ACTIB information

ISRCTN

 

Related research groups

Primary Care & Population Sciences Academic Units
Primary care Research group

Staff

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