Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000133831
Ethics application status
Not yet submitted
Date submitted
18/01/2012
Date registered
31/01/2012
Date last updated
31/01/2012
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
Nil
Universal Trial Number (UTN)
Nil
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
Anxiety

Intervention/exposure
Study type
Interventional
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
Behaviour
Comparator / control treatment
Treatment as usual - Reassurance and GP follow up.
Control group
Active

Outcomes
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.

Eligibility
Key inclusion criteria
Any patient presenting to Emergency Department with non-cardiac chest pain.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment outside Australia
Country [1] 4069 0
New Zealand
State/province [1] 4069 0
Canterbury

Funding & Sponsors
Funding source category [1] 284536 0
Government body
Name [1] 284536 0
Health Research Council of New Zealand
Country [1] 284536 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Christchurch
Address
PO Box 4345
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 283465 0
None
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
Ethics committee country [1] 286522 0
New Zealand
Date submitted for ethics approval [1] 286522 0
16/01/2012
Approval date [1] 286522 0
Ethics approval number [1] 286522 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
roger.mulder@otago.ac.nz
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
roger.mulder@otago.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAn RCT of brief cognitive therapy versus treatment as usual in patients with non-cardiac chest pain.2019https://dx.doi.org/10.1016/j.ijcard.2019.01.067
N.B. These documents automatically identified may not have been verified by the study sponsor.