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

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...

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Main Authors: 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
Format: Article
Published: BioMed Central 2015
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Online Access:https://eprints.nottingham.ac.uk/31492/
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author 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
author_facet 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
author_sort Tyrer, Peter
building Nottingham Research Data Repository
collection Online Access
description 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)
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spelling nottingham-314922020-05-04T17:21:42Z https://eprints.nottingham.ac.uk/31492/ 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 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) BioMed Central 2015-11-24 Article NonPeerReviewed 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. and Crawford, Mike (2015) Cognitive behaviour therapy for non-cardiac pain in the chest (COPIC): a multicentre randomized controlled trial with economic evaluation. BMC Psychology, 3 (41). ISSN 2050-7283 Cognitive behaviour therapy Non-cardiac chest pain Randomized trial http://dx.doi.org/10.1186/s40359-015-0099-7 doi:10.1186/s40359-015-0099-7 doi:10.1186/s40359-015-0099-7
spellingShingle Cognitive behaviour therapy
Non-cardiac chest pain
Randomized trial
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
Cognitive behaviour therapy for non-cardiac pain in the chest (COPIC): a multicentre randomized controlled trial with economic evaluation
title Cognitive behaviour therapy for non-cardiac pain in the chest (COPIC): a multicentre randomized controlled trial with economic evaluation
title_full Cognitive behaviour therapy for non-cardiac pain in the chest (COPIC): a multicentre randomized controlled trial with economic evaluation
title_fullStr Cognitive behaviour therapy for non-cardiac pain in the chest (COPIC): a multicentre randomized controlled trial with economic evaluation
title_full_unstemmed Cognitive behaviour therapy for non-cardiac pain in the chest (COPIC): a multicentre randomized controlled trial with economic evaluation
title_short Cognitive behaviour therapy for non-cardiac pain in the chest (COPIC): a multicentre randomized controlled trial with economic evaluation
title_sort cognitive behaviour therapy for non-cardiac pain in the chest (copic): a multicentre randomized controlled trial with economic evaluation
topic Cognitive behaviour therapy
Non-cardiac chest pain
Randomized trial
url https://eprints.nottingham.ac.uk/31492/
https://eprints.nottingham.ac.uk/31492/
https://eprints.nottingham.ac.uk/31492/