title: 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.
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  ISRCTN44427879.
authors.affiliation: Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.
authors.forename: Hazel
authors.initials: H
authors.lastname: Everitt
authors.affiliation: Department of Biostatistics, Institute of Psychiatry, Psychology and Neurosciences, Psychology and Neuroscience Kings College, London, UK.
authors.forename: Sabine
authors.initials: S
authors.lastname: Landau
authors.affiliation: Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Little
authors.affiliation: Centre for Applications of Health Psychology, University of Southampton, Southampton, UK.
authors.forename: Felicity L
authors.initials: FL
authors.lastname: Bishop
authors.affiliation: Institute of Psychiatry, Psychology and Neuroscience, Kings College, London, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: McCrone
authors.affiliation: Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.
authors.forename: Gilly
authors.initials: G
authors.lastname: O'Reilly
authors.affiliation: Department of Gastroenterology, Southampton University Hospital, Southampton, UK.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Coleman
authors.affiliation: Department of Gastroenterology, Kings College Hospital, London, UK.
authors.forename: Robert
authors.initials: R
authors.lastname: Logan
authors.affiliation: Academic Department of Psychological Medicine, Kings College, London, UK.
authors.forename: Trudie
authors.initials: T
authors.lastname: Chalder
authors.affiliation: Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, Kings College, London, UK.
authors.forename: Rona
authors.initials: R
authors.lastname: Moss-Morris
mesh_terms: D015928:Cognitive Behavioral Therapy / Q000191:economics / Q000379:methods*; D005260:Female; D006801:Humans; D020407:Internet; D043183:Irritable Bowel Syndrome / Q000188:drug therapy / Q000191:economics / Q000628:therapy*; D008019:Life Style; D008297:Male; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D012107:Research Design; D012648:Self Care; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires
keywords: PRIMARY CARE