title: Pilot study evaluating a brief mindfulness intervention for those with chronic pain: study protocol for a randomized controlled trial.
abstract: The burden of chronic pain is a major challenge, impacting the quality of life of patients. Intensive programmes of mindfulness-based therapy can help patients to cope with chronic pain but can be time consuming and require a trained specialist to implement. The self-management model of care is now integral to the care of patients with chronic pain; home-based interventions can be very acceptable, making a compelling argument for investigating brief, self-management interventions. The aim of this study is two-fold: to assess the immediate effects of a brief self-help mindfulness intervention for coping with chronic pain and to assess the feasibility of conducting a definitive randomized controlled trial to determine the effectiveness of such an intervention.
  
  
  
  A randomized controlled pilot study will be conducted to evaluate a brief mindfulness intervention for those with chronic pain. Ninety chronic pain patients who attend hospital outpatient clinics will be recruited and allocated randomly to either the control or treatment group on a 1:1 basis using the computer-generated list of random numbers. The treatment group receives mindfulness audios and the control group receives audios of readings from a non-fiction book, all of which are 15 minutes in length. Immediate effects of the intervention are assessed with brief psychological measures immediately before and after audio use. Mindfulness, mood, health-related quality of life, pain catastrophizing and experience of the intervention are assessed with standardized measures, brief ratings and brief telephone follow-ups, at baseline and after one week and one month. Feasibility is assessed by estimation of effect sizes for outcomes, patient adherence and experience, and appraisal of resource allocation in provision of the intervention.
  
  
  
  This trial will assess whether a brief mindfulness-based intervention is effective for immediately reducing perceived distress and pain with the side effect of increasing relaxation in chronic pain patients and will determine the feasibility of conducting a definitive randomized controlled trial. Patient recruitment began in January 2015 and is due to be completed in June 2016.
  
  
  
  ISRCTN61538090 Registered 20 April 2015.
authors.affiliation: Population Health Research Institute, St George's, University of London, London, UK. p1306542@sgul.ac.uk.
authors.forename: Ana
authors.initials: A
authors.lastname: Howarth
authors.affiliation: Institute of Medical and Biomedical Education, St George's, University of London, London, UK.
authors.forename: Linda
authors.initials: L
authors.lastname: Perkins-Porras
authors.affiliation: Population Health Research Institute, St George's, University of London, London, UK.
authors.forename: Jared G
authors.initials: JG
authors.lastname: Smith
authors.affiliation: Population Health Research Institute, St George's, University of London, London, UK.
authors.forename: Jeevakan
authors.initials: J
authors.lastname: Subramaniam
authors.affiliation: Chronic Pain Service, St George's University Hospitals NHS Foundation Trust, University of London, London, UK.
authors.forename: Claire
authors.initials: C
authors.lastname: Copland
authors.affiliation: Faculty of Health, Social Care and Education, Kingston University and St George's, University of London, London, UK.
authors.forename: Mike
authors.initials: M
authors.lastname: Hurley
authors.affiliation: Faculty of Health, Social Care and Education, Kingston University and St George's, University of London, London, UK.
authors.forename: Iain
authors.initials: I
authors.lastname: Beith
authors.affiliation: Population Health Research Institute, St George's, University of London, London, UK.
authors.forename: Muhammad
authors.initials: M
authors.lastname: Riaz
authors.affiliation: Population Health Research Institute, St George's, University of London, London, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Ussher
mesh_terms: D000223:Adaptation, Psychological; D058443:Catastrophization / Q000523:psychology; D059350:Chronic Pain / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D002985:Clinical Protocols; D006801:Humans; D008131:London; D008603:Mental Health; D064866:Mindfulness; D010147:Pain Measurement; D010349:Patient Compliance; D010865:Pilot Projects; D011614:Psychotherapy, Brief / Q000379:methods*; D011788:Quality of Life; D012107:Research Design; D012648:Self Care / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome
keywords: Chronic pain; Intervention; Mindfulness; Randomized controlled trial