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Cognitive behaviour therapy for non-cardiac pain in the chest (COPIC): a multicentre randomized controlled trial with economic evaluation

Tyrer, Peter; Tyrer, Helen; Cooper, Sylvia; Barrett, Barbara; Kings, Stephanie; Lazarevic, Valentina; Bransby-Adams, Kate; Whittamore, Katherine H.; Walker, Gemma M.; McNulty, Antoinette; Donaldson, Emma; Midgley, Luke; McCoy, Shani; Evered, Rachel; Yang, Min; Guo, Boliang; Lisseman-Stones, Yvonne; Doukani, Asmae; Mulder, Roger; Morriss, Richard K.; Crawford, Mike

Authors

Peter Tyrer

Helen Tyrer

Sylvia Cooper

Barbara Barrett

Stephanie Kings

Valentina Lazarevic

Kate Bransby-Adams

Katherine H. Whittamore

Gemma M. Walker

Antoinette McNulty

Emma Donaldson

Luke Midgley

Shani McCoy

Rachel Evered

Min Yang

Yvonne Lisseman-Stones

Asmae Doukani

Roger Mulder

Richard K. Morriss

Mike Crawford



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/design

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.

Discussion

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.

Trial registration

ISRCTN14711101 (registered 05/03/2015)

Journal Article Type Article
Publication Date Nov 24, 2015
Journal BMC Psychology
Electronic ISSN 2050-7283
Publisher Humana Press
Peer Reviewed Not Peer Reviewed
Volume 3
Issue 41
APA6 Citation Tyrer, P., Tyrer, H., Cooper, S., Barrett, B., Kings, S., Lazarevic, V., …Crawford, M. (2015). Cognitive behaviour therapy for non-cardiac pain in the chest (COPIC): a multicentre randomized controlled trial with economic evaluation. BMC Psychology, 3(41), doi:10.1186/s40359-015-0099-7
DOI https://doi.org/10.1186/s40359-015-0099-7
Keywords Cognitive behaviour therapy, Non-cardiac chest pain, Randomized trial
Publisher URL http://dx.doi.org/10.1186/s40359-015-0099-7
Related Public URLs http://​creativecommons.​org/​licenses/​by/​4.​0/​
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0
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