Condition category
Mental and Behavioural Disorders
Date applied
04/03/2015
Date assigned
05/03/2015
Last edited
26/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chest pain is one of the most common reasons for attending an Accident & Emergency Department. Heart conditions often present with chest pain and many sufferers require emergency treatment to save their life. Most people who experience pain in the chest do not have any serious illness, but because of the potential fatal consequence of untreated heart disease, they are encouraged by medical professionals and publicly displayed advertisements, to seek help. Unfortunately there are very few services to deal with psychological causes of chest pain. Such patients are often inadequately managed, receiving a combination of support and reassurance that may reinforce rather than resolve the problem. We have developed a modification of cognitive behaviour therapy for chest pain (CBT-CP). It is administered mainly by trained general nurses and preliminary results have shown it to work well. Here, we want to test its value formally in a randomised controlled trial.

Who can participate?
Patients aged between 16 and 75 with significant chest pain for which no significant disease explaining the condition has been found.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention) are given between 4 and 10 sessions of CBT-CP treatment over a three month period. The treatment involves an initial assessment with a trained therapist followed by 3 to 9 further sessions of treatment each lasing about an hour, the number depending on the complexity and speed of response to treatment. Those in group 2 (control) are given the standard care offered by cardiology and other hospital clinics by general practitioners. Each patient is followed over a one year period and in which they undergo assessments of their anxiety levels, depression, amount of pain and discomfort experienced and general quality of life.

What are the possible benefits and risks of participating?
No adverse effects have been noted to date.

Where is the study run from?
The trial is being run from the Royal Berkshire Hospital, Kings Mill Hospital and the Hillingdon Hospital in the UK.

When is the study starting and how long is it expected to run for?
July 2012 to March 2016.

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
1. Mrs Sylvia Cooper (public)
s.cooper@imperial.ac.uk
2. Professor Peter Tyrer (scientific)
p.tyrer@imperial.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Mrs Sylvia Cooper

ORCID ID

Contact details

Centre for Mental Health
Imperial College
7th Floor
Commonwealth Building
Hammersmith Hospital
London
W12 0NN
United Kingdom
0207 386 1237
s.cooper@imperial.ac.uk

Type

Scientific

Additional contact

Dr Peter Tyrer

ORCID ID

http://orcid.org/0000-0002-0358-1459

Contact details

Centre for Mental Health
Imperial College
7th Floor
Commonwealth Building
Hammersmith Hospital
London
W12 0NN
United Kingdom
0208 383 4161
p.tyrer@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11424

Study information

Scientific title

Randomised controlled trial of modified cognitive behaviour therapy for non-cardiac chest pain

Acronym

COPIC

Study hypothesis

Does an adapted form of cognitive behaviour therapy for non-cardiac chest pain lead to reduced anxiety over health and lower health service costs than standard care over 6 months and one year.

Ethics approval

NRES Committee East Midlands - Northampton, 22/11/2011, ref: 11/EM/0376

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Topic: Mental Health; Subtopic: Anxiety, Stress-related and somatoform; Disease: Anxiety, Stress-related and somatoform disorders

Intervention

Equal (randomised) allocation of patients to:
1. Cognitive behaviour therapy arm, in which between 4 and 10 sessions of treatment are given by a supervised trained therapist over a three month period
2. Standard care given in cardiology and other hospital clinics, and by general practitioners

Follow Up Length: 12 month(s)

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Change in scores on the Health Anxiety Inventory between baseline assessment and 6 months

Secondary outcome measures

1. Change in scores on the Health Anxiety Inventory between baseline assessment and 12 months
2. Change in scores on the Lucock Health Anxiety Questionnaire-Chest Pain version between baseline assessment and 6 months
3. Visual analogue scales for pain and discomfort between baseline assessment and 6 months
4. Schedule for Evaluating Persistent Symptoms (SEPS) between baseline assessment and 6 months
5. Hospital Anxiety and Depression Scale - Anxiety and Depression components between baseline assessment and 6 months
6. Quality of life (EQ-5D) between baseline assessment and 6 months
7. Social functioning (SFQ) between baseline assessment and 6 months
8. Costs using the Adult Service Use Schedule (AD-SUS) between baseline assessment and 6 months

Overall trial start date

10/07/2012

Overall trial end date

31/03/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who satisfy the criteria for:
1. Significant chest pain on at least two separate occasions in the past year in which no significant pathology explaining the symptoms was found
2. Signed consent to take part in the study
3. Aged between 16 and 75

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 68; UK Sample Size: 68; Description: study team confirmed sample size is 120. 31/5/12Study team advised sample size 100. 12/7/12Study team advised 'the final total will be enough for research purposes as the drop-out rate is less than we originally expected.' 4/12/14

Participant exclusion criteria

Patients who are:
1. Under active psychiatric care
2. Have had a new prescription of a psychoactive drug within the previous two months
3. Receiving, or on waiting list for, a psychological treatment. Those who are currently stable and on regular psychoactive medication (for more than 2 months) are eligible for the study.

Recruitment start date

10/07/2012

Recruitment end date

31/01/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Berkshire Hospital
London Rd
Reading
RG1 5AN
United Kingdom

Trial participating centre

Kings Mill Hospital
Mansfield Road Sutton-in-Ashfield
Nottinghamshire
NG17 4JL
United Kingdom

Trial participating centre

The Hillingdon Hospital
Pield Heath Road
Uxbridge
UB8 3NN
United Kingdom

Sponsor information

Organisation

Imperial College of Science, Technology and Medicine

Sponsor details

Du Cane Road
London
W12 0NN
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Protocol paper in preparation to be submitted to Trials in September 2015. Main results to be published in both psychiatric and medical journals.

Intention to publish date

30/09/2015

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26596540

Publication citations

Additional files

Editorial Notes