Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000872134
Ethics application status
Approved
Date submitted
2/05/2019
Date registered
19/06/2019
Date last updated
19/06/2019
Date data sharing statement initially provided
19/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Cognitive Behaviour Therapy for Non Cardiac Chest Pain on re-presentations for Non- Cardiac Chest Pain (NCCP) in Emergency Department (ED)
Scientific title
Psychological interventions for reducing non-cardiac Emergency Department Representations – A Randomised Controlled Trial
Secondary ID [1] 298127 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Cardiac Chest Pain 312660 0
Condition category
Condition code
Emergency medicine 311157 311157 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be an information sheet provided at ED and a client consent form with information about the trial and that all participation is voluntary. The patients will also be provided information about the treatment and that they have a right to withdraw at any point in time. The intervention will consist of Cognitive Behaviour Therapy which will target non cardiac chest pain as a symptoms
it will be delivered by a fully registered psychologist
it will be delivered as a face to face intervention for 6 sessions over 6 to 8 weeks
the duration of any single session will generally be 1 hour per week
the intervention will be delivered from the Townsville Hospital
assessing the adherence to intervention will be a part of the psychotherapy
Intervention code [1] 314348 0
Behaviour
Intervention code [2] 314717 0
Treatment: Other
Comparator / control treatment
Wait List controls will be provided with usual care through usual ED processes which involve being referred back to their GP
they will be offered treatment after 6 months
Control group
Active

Outcomes
Primary outcome [1] 319930 0
The primary outcome measure is number of re-presentations to ED over 24 weeks period.
This will be assessed using hospital records of ED re-presentations over the 24 week period
Timepoint [1] 319930 0
24 Weeks
Secondary outcome [1] 369921 0
Several Patient Reported Outcome Measures will be assessed throughout the study.
1 Symptom related distress i.e. Chest pain frequency and intensity assessed through :
• Chest pain frequency (Chambers et al 2014)
Timepoint [1] 369921 0
8 weeks; 16 weeks; 24 weeks
Secondary outcome [2] 371409 0
Psychological distress related outcomes such as
• K-10 (Kessler et al 2002)
Timepoint [2] 371409 0
8 weeks; 16 weeks; 24 weeks
Secondary outcome [3] 371410 0
Quality of Life related measure ie

Quality of Life measure (AQoL 8)
Timepoint [3] 371410 0
8 weeks; 16 weeks; 24 weeks
Secondary outcome [4] 371712 0
Chest Pain severity and problem ratings (Chambers et al 2014)
Together, This measure will provide information on interference with daily activities.
Timepoint [4] 371712 0
8 weeks; 16 weeks and 24 weeks
Secondary outcome [5] 371713 0
presence of co-morbid psychological conditions assessed through DASS 21 (Lovibond and Lovibond 1995)
Timepoint [5] 371713 0
8 week, 16 week and 24 week

Eligibility
Key inclusion criteria
All patients aged 18 to 65yrs who present to THHS ED with a discharge diagnosis of non-cardiac chest pain (NCCP) during the study period,.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Since therapy involves providing standard psychotherapy which involves a fair degree of proficiency with English language, it is proposed that the following are excluded from this RCT in the interest of controlling for relevant variables:
• Individuals with limited proficiency in English language or with sensory or other impairment which impacts on expression and comprehension of English language
• Individuals from indigenous or culturally and linguistically diverse backgrounds
In addition it is suggested that individuals with the following conditions be excluded from this study
i. Those who have an underlying cardiac pathology – for the purpose of the study this is defined as individuals who have a diagnosed coronary artery disease This is because this represents a high-risk group who might need to re-present to the ED and therefore any gains made due to psychotherapy might not be best reflected through ED representations as the primary measure of the intervention's success.
ii. Individuals who have a co-morbid neurological condition: This includes a group of individuals who have had stroke or a space occupying lesion or those with a history of seizure disorder. Once again this represents a high-risk group who might need to re-present to the ED and therefore any gains made due to psychotherapy might not be best reflected through ED representations as the primary measure of the intervention's success
iii. Individuals who have a co-morbid psychiatric condition for which they are on psychotropic medication:

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)
Allocation will not be concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Individuals will be randomized to either the treatment or non-treatment conditions. Block randomization will be used to ensure there are approximately equal numbers of participants allocated to intervention and control groups (ratio of 1:1). For the purpose of randomization, we will use a computer-generated code, using the site www.randomization.com .
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
individuals will be randomly allocated as described above. The study will be single blinded. The assessors responsible for collecting the information at baseline, and the 8, 16 and 24 week follow up periods will be blind to the group (i.e. treatment or control) to which patients have been randomized. The participants however will not be able to be blinded. Those who are allocated to the treatment condition will be informed that as a part of the study they will be required to attend up to six sessions with a psychologist
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
For continuous variables, independent samples t-tests will be used to determine whether there are differences between groups at baseline. Chi-squared tests will be used for categorical variables. At each follow-up point, difference scores will be calculated to represent the difference between baseline score and follow-up score at that time point. Between group analyses will then be conducted to assess differences on the various outcome measures, adjusting for relevant confounding variables. In addition, event rates will be calculated for each outcome measure, and relative risks calculated (event rate in intervention group divided by event rate in control group). This relative risk will then be used to calculate a range of relevant relative and absolute measures (Relative Risk Reduction, Absolute Risk Reduction, Number Needed to Treat).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/07/2019
Actual
Date of last participant enrolment
Anticipated
30/06/2020
Actual
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13680 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 26364 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 302658 0
Hospital
Name [1] 302658 0
Study Education Research Trust Account (SERTA) at the Townsvile Hospital
Country [1] 302658 0
Australia
Primary sponsor type
Hospital
Name
The Townsville Hospital
Address
The Townsville Hospital
100 Angus Smith Avenue
Douglas QLD 4814
Country
Australia
Secondary sponsor category [1] 302578 0
None
Name [1] 302578 0
Address [1] 302578 0
Country [1] 302578 0
Other collaborator category [1] 280664 0
University
Name [1] 280664 0
James Cook University
Address [1] 280664 0
James Cook Drive
Douglas QLD 4814
Country [1] 280664 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303280 0
The Townsville Hospital and Health Service HREC
Ethics committee address [1] 303280 0
The Townsville Hospital
100 Angus Smith Avenue
Douglas QLD 4814
Ethics committee country [1] 303280 0
Australia
Date submitted for ethics approval [1] 303280 0
Approval date [1] 303280 0
05/03/2019
Ethics approval number [1] 303280 0
HREC Reference number: HREC/2018/QTHS/47872

Summary
Brief summary
The primary aim of the study is to reduce the number of ED re-presentations in the target population. Specifically, the aim of this study is to determine whether there are differences in outcomes for individuals who present to ED with non-cardiac chest pain and receive psychological intervention vs those who receive usual care, in relation to ED re-presentations over a 6-month period.
The secondary aim is to study if the intervention will result in an improvement in other patient outcomes, such as symptomatology, the quality of life and reduction in psychological distress and whether or not this intervention is cost effective
This is a Single-blind randomised controlled trial in which the assessor is blind to treatment vs standard care condition.
All individuals who meet the selection criteria will be invited to participate in the research. Consenting participants who meet the selection criteria, will be randomly allocated to either -:
A) Psychological treatment group consisting of 6 sessions of psychotherapy over 6-8 weeks, which will be conducted by a fully qualified Psychologist (Director of Psychology, THHS)
B) Usual care/ Wait list controls (Wait list controls have been included to ensure that all patients in the trial have access to treatment eventually should they so desire, since this treatment is evidence based)

Outcomes will be assessed for both groups at baseline, 8 weeks; 16 weeks and 24 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93118 0
Ms Vidula Garde
Address 93118 0
Department of Psychology
The Townsville Hospital
100 Angus Smith Drive
Townsville
Douglas QLD 4814
Country 93118 0
Australia
Phone 93118 0
+61 7 44335263
Fax 93118 0
Email 93118 0
[email protected]
Contact person for public queries
Name 93119 0
Vidula Garde
Address 93119 0
Department of Psychology
The Townsville Hospital
100 Angus Smith Drive
Townsville
Douglas QLD 4814
Country 93119 0
Australia
Phone 93119 0
+61 7 44335263
Fax 93119 0
Email 93119 0
[email protected]
Contact person for scientific queries
Name 93120 0
Vidula Garde
Address 93120 0
Department of Psychology
The Townsville Hospital
100 Angus Smith Drive
Townsville
Douglas QLD 4814
Country 93120 0
Australia
Phone 93120 0
+61 7 44335263
Fax 93120 0
Email 93120 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participation data underlying published results will be be shared
When will data be available (start and end dates)?
at the finish of the trial i.e July 2020 onwards for up to 5 years
Available to whom?
researchers who provide a methodologically sound proposal and on case by case basis at the discretion of primary sponsor
Available for what types of analyses?
only to achieve the aims in the approved proposal, and for meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator as well as upon signing relevant data access agreement with The Townsville Hospital (TTH)


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
No additional documents have been identified.