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Research project

ACTIB - Accessing Cognitive Therapy in Irritable Bowel

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

Staff

Lead researcher

Professor Hazel Everitt

Professor of Primary Care Research

Research interests

  • Supporting Self-management 
  • Healthcare communication
  • Development of digital interventions
Other researchers

Professor Paul Little

Professor in Primary Care Research

Professor Flis Bishop

Professor of Health Psychology

Research interests

  • Placebo effects and context effects in healthcare
  • Complementary and integrative medicine utilisation
  • Treatment decision-making and adherence

Collaborating research institutes, centres and groups

Research outputs

Sabine Landau,
Gilly O’Reilly,
Alice Sibelli,
Stephanie Hughes,
Sula Windgassen,
Rachel Holland,
Paul McCrone,
Kim Goldsmith,
Nicholas Coleman,
Robert Logan,
Trudie Chalder,
& Rona Moss-Morris
, 2019 , The Lancet Gastroenterology & Hepatology , 4 (11) , 863--872
Type: article
Sabine Landau,
Gilly O'reilly,
Alice Sibelli,
Sula Windgassen,
Rachel Holland,
Paul McCrone,
Kimberley Goldsmith,
Nicholas Coleman,
Robert Logan,
Trudie Chalder,
& Rona Moss-Morris
, 2019 , Gut , 68 (9) , 1613--1623
Type: article
Alice Sibelli,
Trudie Chalder,
Joseph Chilcot,
& Rona Moss-Morris
, 2018 , Journal of Psychosomatic Research , 105 , 1--13
Type: article
J. Matthew Harvey,
Alice Sibelli,
Trudie Chalder,
Rona Moss-Morris,
, 2018 , British Journal of Health Psychology
Type: article
Alice Sibelli,
Rona Moss-Morris,
Trudie Chalder,
Sula Windgassen,
, 2018 , British Journal of General Practice , 68 (674) , e654--e662
Type: article