Project overview
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.
The ACTIB trial has been incorporated into the The British Society of Gastronenterology guidelines on the management of irritable bowel syndrome. April 2021.
Mahana Therapeutics Obtains FDA Marketing Authorization for the First Prescription Digital Therapeutic to Treat Irritable Bowel Syndrome press release 8 December 2020.
NIHR blog published on CBT for IBS.
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.
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 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.
Trial Registration ISRCTN
Funders Number: 11/69/02
The project commenced in September 2013. All participants have now been recruited. Results of the trial are likely to be published in 2019. We are also continuing follow up to 24 months.
Contact for the study: Mrs Stephanie Hughes
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)
Mrs 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
The ACTIB trial has been incorporated into the The British Society of Gastronenterology guidelines on the management of irritable bowel syndrome. April 2021.
Mahana Therapeutics Obtains FDA Marketing Authorization for the First Prescription Digital Therapeutic to Treat Irritable Bowel Syndrome press release 8 December 2020.
NIHR blog published on CBT for IBS.
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.
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 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.
Trial Registration ISRCTN
Funders Number: 11/69/02
The project commenced in September 2013. All participants have now been recruited. Results of the trial are likely to be published in 2019. We are also continuing follow up to 24 months.
Contact for the study: Mrs Stephanie Hughes
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)
Mrs 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
Staff
Lead researcher
Other researchers
Collaborating research institutes, centres and groups
Research outputs
Alice Sibelli,
Trudie Chalder,
Paul Workman,
& Rona Moss-Morris
, 2017
, British Journal of Health Psychology
, 22 (4) , 737--762
DOI: 10.1111/bjhp.12264
Type: article
Sabine Landau,
Paul McCrone,
Gilly O'Reilly,
Nicholas Coleman,
Robert Logan,
Trudie Chalder,
& Rona Moss-Morris
, 2015
, BMJ Open
, 5 , 1--15
Type: article