title: Cognitive behaviour therapy for non-cardiac pain in the chest (COPIC): a multicentre randomized controlled trial with economic evaluation.
abstract: BACKGROUND
  Most patients with chest pain have nothing wrong with their cardiac function. Psychological forms of treatment for this condition are more likely to be successful than others.
  
  
  METHODS
  A two-arm parallel controlled randomized trial of standard care versus a modified form of cognitive behaviour therapy for chest pain (CBT-CP) in patients who have attended emergency hospital services. Inclusion criteria include (i) emergency attendance more than once in the previous year with chest pain when no physical pathology has been found, (ii) aged between 16 and 75, (iii) signed consent to take part in the study. Exclusion criteria are (i) under current psychiatric care, (ii) those who have had new psychotropic drugs prescribed within the last two months, (iii) are receiving or about to receive a formal psychological treatment. Those satisfying these criteria will be randomized to 4-10 sessions of CBT-CP or to continue with standard care. Participants are randomized using a remote web-based system using permuted stacked blocks stratified by study centre. Assessment is carried out at baseline by researchers subsequently masked to allocation and at 6 months and 1 year after randomization. The primary outcome is the Health Anxiety Inventory score at 6 months, and secondary outcomes are generalised anxiety and depressive symptoms, the Lucock Health Anxiety Questionnaire adapted for chest pain, visual analogue scales for chest pain and discomfort (Inskip Scale), the Schedule for Evaluating Persistent Symptoms (SEPS), health related quality of life, social functioning and medical resource usage. Intention to treat analyses will be carried out with clinical and functioning data, and a cost-utility analysis will compare differences in total costs and differences in quality of life using QALYs derived from the EQ-5D. The data will also be linked to another parallel study in New Zealand where 126 patients with the same inclusion criteria have been treated in a similar trial; the form of analysis of the combined data has yet to be determined.
  
  
  CONCLUSIONS
  The morbidity and costs of non-cardiac chest pain are substantial and if a simple psychological treatment given by health professionals working in medical departments is beneficial it should prove to be of great value. Combining data with a similar study in New Zealand is an additional asset.
  
  
  BACKGROUND
  ISRCTN14711101 (registered 05/03/2015).
authors.affiliation: Centre for Mental Health, Imperial College, Claybrook Road, London, W6 8LN, UK. p.tyrer@imperial.ac.uk.|Centre for Mental Health, Imperial College, 7th Floor, Commonwealth Building, Hammersmith Hospital, London, W12 0NN, UK. p.tyrer@imperial.ac.uk.
authors.forename: Peter
authors.initials: P
authors.lastname: Tyrer
authors.affiliation: Centre for Mental Health, Imperial College, Claybrook Road, London, W6 8LN, UK. h.tyrer@imperial.ac.uk.
authors.forename: Helen
authors.initials: H
authors.lastname: Tyrer
authors.affiliation: Centre for Mental Health, Imperial College, Claybrook Road, London, W6 8LN, UK. s.cooper@imperial.ac.uk.
authors.forename: Sylvia
authors.initials: S
authors.lastname: Cooper
authors.affiliation: King's Health Economics, King's College, London, De Crespigny Park, London, SE5 8AF, UK. barbara.m.barrett@kcl.ac.uk.
authors.forename: Barbara
authors.initials: B
authors.lastname: Barrett
authors.affiliation: East Midlands Clinical Research Network, Institute of Mental Health, Nottingham, NG7 2TU, UK. steph.kings@nottshc.nhs.uk.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Kings
authors.affiliation: East Midlands Clinical Research Network, Institute of Mental Health, Nottingham, NG7 2TU, UK. valentina.lazarevic@nottshc.nhs.uk.
authors.forename: Valentina
authors.initials: V
authors.lastname: Lazarevic
authors.affiliation: East Midlands Clinical Research Network, Institute of Mental Health, Nottingham, NG7 2TU, UK. kate.bransby-adams@nottshc.nhs.uk.
authors.forename: Kate
authors.initials: K
authors.lastname: Bransby-Adams
authors.affiliation: East Midlands Clinical Research Network, Institute of Mental Health, Nottingham, NG7 2TU, UK. katherine.whittamore2@nottingham.ac.uk.
authors.forename: Katherine
authors.initials: K
authors.lastname: Whittamore
authors.affiliation: East Midlands Clinical Research Network, Institute of Mental Health, Nottingham, NG7 2TU, UK. gemma.walker@nottingham.ac.uk.
authors.forename: Gemma
authors.initials: G
authors.lastname: Walker
authors.affiliation: North West London Clinical Research Network, Hammersmith Hospital, London, W12 0NN, UK. amcnulty1@nhs.net.
authors.forename: Antoinette
authors.initials: A
authors.lastname: McNulty
authors.affiliation: Berkshire Healthcare NHS Foundation Trust, Skimped Hill Lane, Bracknell, Berkshire, RG12 1BQ, UK. emma.donaldson@berkshire.nhs.uk.
authors.forename: Emma
authors.initials: E
authors.lastname: Donaldson
authors.affiliation: Berkshire Healthcare NHS Foundation Trust, Skimped Hill Lane, Bracknell, Berkshire, RG12 1BQ, UK. luke.midgley@berkshire.nhs.uk.
authors.forename: Luke
authors.initials: L
authors.lastname: Midgley
authors.affiliation: Berkshire Healthcare NHS Foundation Trust, Skimped Hill Lane, Bracknell, Berkshire, RG12 1BQ, UK. shani.emmons@btinternet.com.
authors.forename: Shani
authors.initials: S
authors.lastname: McCoy
authors.affiliation: Central and North West London NHS Foundation Trust, Hampstead Road, London, NW1 7QY, UK. rachel.evered@gmail.com.
authors.forename: Rachel
authors.initials: R
authors.lastname: Evered
authors.affiliation: School of Public Health, Sichuan University, Chengdu, Sichuan, China. yangmin2013@scu.edu.cn.
authors.forename: Min
authors.initials: M
authors.lastname: Yang
authors.affiliation: Faculty of Medicine & Health Sciences, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK. boliang.guo@nottingham.ac.uk.
authors.forename: Boliang
authors.initials: B
authors.lastname: Guo
authors.affiliation: Kings Mill Hospital, Sutton-in-Ashfield, Nottinghamshire, NG17 4JL, UK. yvonne.lisseman-stones@sfh-tr.nhs.uk.
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Lisseman-Stones
authors.affiliation: London School of Hygiene and Tropical Health, Keppel Street, London, WC1E 7HT, UK. asmae.doukani@lshtm.ac.uk.
authors.forename: Asmae
authors.initials: A
authors.lastname: Doukani
authors.affiliation: Department of Psychological Medicine, University of Otago, Riccarton Avenue, PO Box 4345, Christchurch, 8140, New Zealand. roger.mulder@otago.ac.nz.
authors.forename: Roger
authors.initials: R
authors.lastname: Mulder
authors.affiliation: Faculty of Medicine & Health Sciences, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK. richard.morriss@nottingham.ac.uk.
authors.forename: Richard
authors.initials: R
authors.lastname: Morriss
authors.affiliation: Centre for Mental Health, Imperial College, Claybrook Road, London, W6 8LN, UK. m.crawford@imperial.ac.uk.
authors.forename: Mike
authors.initials: M
authors.lastname: Crawford
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002637:Chest Pain / Q000523:psychology / Q000628:therapy*; D015928:Cognitive Behavioral Therapy / Q000191:economics / Q000379:methods*; D003362:Cost-Benefit Analysis; D004739:England; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D019057:Quality-Adjusted Life Years; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult