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Trial registered on ANZCTR

Registration number
Ethics application status
Not yet submitted
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Non-Cardiac Chest Pain. Evaluation of a brief psychosocial intervention for patients presenting in an Emergency Department with non-cardiac chest pain to see whether this reduces non-essential health service use.
Scientific title
The effects of health anxiety cognitive behavioural therapy (CBT) versus treatment as usual (TAU) on representations to the emergency department (ED) or general practitioner (GP) over the next 12 months in patients with non-cardiac chest pain (NCPP).
Secondary ID [1] 279750 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-cardiac chest pain 285613 0
Condition category
Condition code
Cardiovascular 285805 285805 0 0
Other cardiovascular diseases
Mental Health 285813 285813 0 0

Study type
Description of intervention(s) / exposure
NCCP modified cognitive behaviour therapy (CBT).
a) 1 x 1 hour of treatment per week.
b) Overall duration of treatment is four weeks
c) Mode of administration is one-on-one, face-to-face sessions with health clinicians.
Intervention code [1] 284066 0
Treatment: Other
Intervention code [2] 284143 0
Comparator / control treatment
Treatment as usual - Reassurance and GP follow up.
Control group

Primary outcome [1] 286387 0
Patient re-presenting at ED or GP with NCCP.
Using data linkage with patient National Health Index (NHI) number.
Timepoint [1] 286387 0
1 year after randomisation
Secondary outcome [1] 295605 0
Mean change on Health Anxiety Inventory (HAI)
Timepoint [1] 295605 0
1 year after randomisation.
Secondary outcome [2] 295606 0
Mean change on Hospital Anxiety and Depression Scale(HADS)
Timepoint [2] 295606 0
1 year after randomisation.
Secondary outcome [3] 295607 0
Mean change on SF-36
Timepoint [3] 295607 0
1 year after randomisation.

Key inclusion criteria
Any patient presenting to Emergency Department with non-cardiac chest pain.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
a) Unable to understand English or Maori sufficiently to be able to complete questionnaires;

b) Currently cardiac pathology suspected and being investigated;

c) Currently under psychiatric care.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Parallel group randomised controlled trial utilising a 1:1 allocation.

Allocation is concealed using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be allocated sequentially using block randomisation in permuted blocks prepared in advance by the study statistician.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 4069 0
New Zealand
State/province [1] 4069 0

Funding & Sponsors
Funding source category [1] 284536 0
Government body
Name [1] 284536 0
Health Research Council of New Zealand
Address [1] 284536 0
PO Box 5541
Wellesley Street
Auckland 1141
Country [1] 284536 0
New Zealand
Primary sponsor type
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
New Zealand
Secondary sponsor category [1] 283465 0
Name [1] 283465 0
Address [1] 283465 0
Country [1] 283465 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286522 0
Upper South A Regional Ethics Committee
Ethics committee address [1] 286522 0
Ministry of Health
PO Box 3877
Christchurch 8011
Ethics committee country [1] 286522 0
New Zealand
Date submitted for ethics approval [1] 286522 0
Approval date [1] 286522 0
Ethics approval number [1] 286522 0

Brief summary
Chest pain is one of the commonest reasons for presenting to an Emergency Department (ED). The majority of this chest pain is non-cardiac in origin. Current methods of dealing with this non-cardiac chest pain (NCCP) using reassurance are not very effective. We propose to evaluate a brief (3-4 session) psychosocial intervention using modified cognitive behavioural therapy (CBT) techniques to reduce the distress associated with NCCP. This will include teaching coping skills, stress management and cardiac risk factor reduction. This NCCP directed CBT may help reduce the inappropriate use of health services resulting in significant cost savings for New Zealand. The training and supervision requirements are modest and ED and cardiac nurses can be trained to use these techniques to enhance patient outcomes throughout New Zealand.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 33649 0
Address 33649 0
Country 33649 0
Phone 33649 0
Fax 33649 0
Email 33649 0
Contact person for public queries
Name 16896 0
Professor Roger Mulder
Address 16896 0
Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 16896 0
New Zealand
Phone 16896 0
++64 3 3720400
Fax 16896 0
++64 3 3720407
Email 16896 0
Contact person for scientific queries
Name 7824 0
Professor Roger Mulder
Address 7824 0
Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 7824 0
New Zealand
Phone 7824 0
++64 3 3720400
Fax 7824 0
++64 3 3720407
Email 7824 0

No information has been provided regarding IPD availability
Summary results
No Results