title: The use of mindfulness-based cognitive therapy for improving quality of life for inflammatory bowel disease patients: study protocol for a pilot randomised controlled trial with embedded process evaluation.
abstract: BACKGROUND
  Inflammatory bowel disease (IBD) is a chronic condition with an unpredictable disease course. Rates of anxiety and depression among IBD patients in relapse (active disease symptoms) as well as in remission are higher than in the general population. Previous studies suggest that the prolonged effect of pain, anxiety, distress and depression have a detrimental effect on patients'quality of life (QoL). Poor QoL in itself is associated with further symptom relapse. Mindfulness based cognitive therapy (MBCT) is a psychological group intervention that has the potential to improve QoL. When used in other chronic conditions, it demonstrated reduced negative effect from pain and psychological factors at completion of an 8-week MBCT course. The effect of MBCT has never been researched in IBD. The aim of this study is to obtain the information required to design a full scale randomised controlled trial (RCT) that will examine the effectiveness of MBCT in improving quality of life for IBD patients.
  
  
  METHODS
  This is an exploratory RCT with embedded process evaluation. Forty IBD patients will be recruited from NHS outpatient gastroenterology clinics and will be randomised to either a MBCT (intervention) group or to a wait-list (control) group. All participants will undergo 16 h of structured group training over an 8-week period, with the control group starting 6 months later than the intervention group. Primary outcomes are recruitment, completion/retention rates and adherence and adaptation to the MBCT manual for IBD patients. The secondary outcome is to assess the feasibility of collecting reliable and valid data on proposed outcome measures such as quality of life, anxiety, depression, disease activity and mindful awareness. The process evaluation will use a survey and focus groups to assess the acceptability of the intervention and trial procedures for IBD patients.
  
  
  CONCLUSIONS
  The outcomes of this study will help define the barriers, uptake and perceived benefits of MBCT program for IBD patients. This information will enable the design of a full-scale study assessing the effect of MBCT on quality of life for IBD patients.
  
  
  BACKGROUND
  Current Controlled Trials: ISRCTN27934462.
authors.affiliation: Centre for Health Science, School of Nursing, Midwifery and Health, University of Stirling, Inverness, Scotland. ms84@stir.ac.uk.
authors.forename: Mariyana
authors.initials: M
authors.lastname: Schoultz
authors.forename: Iain M
authors.initials: IM
authors.lastname: Atherton
authors.forename: Gill
authors.initials: G
authors.lastname: Hubbard
authors.forename: Angus J M
authors.initials: AJ
authors.lastname: Watson
mesh_terms: D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003625:Data Collection; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000523:psychology*; D064866:Mindfulness; D018579:Patient Selection; D011788:Quality of Life; D012107:Research Design; D018401:Sample Size