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Assessing Cognitive behavioural Therapy in Irritable Bowel (ACTIB): protocol for a randomised controlled trial of clinical-effectiveness and cost-effectiveness of therapist delivered cognitive behavioural therapy and web-based self-management in irritable bowel syndrome in adults
  1. Hazel Everitt1,
  2. Sabine Landau2,
  3. Paul Little1,
  4. Felicity L Bishop3,
  5. Paul McCrone4,
  6. Gilly O'Reilly1,
  7. Nicholas Coleman5,
  8. Robert Logan6,
  9. Trudie Chalder7,
  10. Rona Moss-Morris8
  11. on behalf of the ACTIB trial team
    1. 1Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, UK
    2. 2Department of Biostatistics, Institute of Psychiatry, Psychology and Neurosciences, Psychology and Neuroscience Kings College, London, UK
    3. 3Centre for Applications of Health Psychology, University of Southampton, Southampton, UK
    4. 4Institute of Psychiatry, Psychology and Neuroscience, Kings College, London, UK
    5. 5Department of Gastroenterology, Southampton University Hospital, Southampton, UK
    6. 6Department of Gastroenterology, Kings College Hospital, London, UK
    7. 7Academic Department of Psychological Medicine, Kings College, London, UK
    8. 8Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, Kings College, London, UK
    1. Correspondence to Dr Hazel Everitt; hae1{at}soton.ac.uk

    Abstract

    Introduction Irritable bowel syndrome (IBS) affects 10–22% of the UK population, with England's annual National Health Service (NHS) costs amounting to more than £200 million. Abdominal pain, bloating and altered bowel habit affect quality of life, social functioning and time off work. Current treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many people suffer ongoing symptoms. Cognitive behaviour therapy (CBT) and self-management can be helpful, but availability is limited.

    Methods and analysis To determine the clinical- and cost-effectiveness of therapist delivered cognitive behavioural therapy (TCBT) and web-based CBT self-management (WBCBT) in IBS, 495 participants with refractory IBS will be randomised to TCBT plus treatment as usual (TAU); WBCBT plus TAU; or TAU alone. The two CBT programmes have similar content. However, TCBT consists of six, 60 min telephone CBT sessions with a therapist over 9 weeks, at home, and two ‘booster’ 1 hour follow-up phone calls at 4 and 8 months (8 h therapist contact time). WBCBT consists of access to a previously developed and piloted WBCBT management programme (Regul8) and three 30 min therapist telephone sessions over 9 weeks, at home, and two ‘booster’ 30 min follow-up phone calls at 4 and 8 months (2½ h therapist contact time). Clinical effectiveness will be assessed by examining the difference between arms in the IBS Symptom Severity Score (IBS SSS) and Work and Social Adjustment Scale (WASAS) at 12 months from randomisation. Cost-effectiveness will combine measures of resource use with the IBS SSS at 12 months and quality-adjusted life years.

    Ethics and dissemination This trial has full ethical approval. It will be disseminated via peer reviewed publications and conference presentations. The results will enable clinicians, patients and health service planners to make informed decisions regarding the management of IBS with CBT.

    Trial registration number ISRCTN44427879.

    • PRIMARY CARE

    This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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