Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000265976
Ethics application status
Approved
Date submitted
9/03/2011
Date registered
11/03/2011
Date last updated
11/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a short cognitive and behavioural therapy intervention on illness representations and quality of life in
individuals who sustain a traumatic injury: A pilot study.
Scientific title
The effect of a short cognitive and behavioural therapy intervention on illness representations and quality of life in
individuals who sustain a traumatic injury: A pilot study.
Secondary ID [1] 259764 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic injury 261340 0
Condition category
Condition code
Injuries and Accidents 259490 259490 0 0
Other injuries and accidents
Mental Health 259500 259500 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two sessions of cognitive-behavioural therapy delivered face-to-face. Sessions will last one hour duration and will be one on one with a provisionally registered or fully registered psychologist. Sessions will be approximately three weeks apart (the first will be delivered approximately one week before discharge from hospital, the second will be delivered two weeks following discharge).

Participants will learn skills for relaxation, challenging unhelpful thoughts, how to manage uncertainty.
Intervention code [1] 264187 0
Behaviour
Intervention code [2] 264194 0
Prevention
Comparator / control treatment
Standard medical care (may include some or all of the following: review of condition by trained medical staff, prescribing medication, physical rehabilitation)
Control group
Active

Outcomes
Primary outcome [1] 262298 0
Health-related quality of life (as measured by the Short-Form 12)
Timepoint [1] 262298 0
end of treatment (i.e., second session) and three months follow-up
Secondary outcome [1] 273483 0
Illness representations (i.e., the participants' view of their injury) and health-related quality of life.
This will be measured by the illness perception questionnaire-revised (IPQ-R) and the Short-Form 12 (SF-12)
Timepoint [1] 273483 0
end of treatment (i.e., second session) and three months follow-up

Eligibility
Key inclusion criteria
Greater than 18 years of age
Sustained a traumatic injury requiring hospitalization for 3 days or more
English-speaking (to an 8th grade level)
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with Brain Injury (Glasgow Coma Score < 13)
Spinal cord injury
Hangings
Poisonings
Patients not discharged home (e.g., sent to extended treatment and rehabilitation ward).

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Just prior to a patient being transferred from the ICU ward, nursing staff from the ward will let the patient know of some research being done through Griffith university for people who have had an injury and ask if they would like for the researcher to contact them to explain the study. If the patient agrees, the researcher will be given their name and ward and will make contact and go through information and consent form. If the patient says no, the patient will have no contact from the researcher.

The patient will be allocated to either a treatment or control group on the basis of their scores on the illness perception questionnaire (this technique was advised after the study underwent statistical and methodological review at Griffith University to ensure for robust findings).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264633 0
University
Name [1] 264633 0
Griffith university
Country [1] 264633 0
Australia
Primary sponsor type
University
Name
Griffith university
Address
School of Psychology
Gold Coast Campus
Griffith University
Southport
QLD 4222
Country
Australia
Secondary sponsor category [1] 263771 0
None
Name [1] 263771 0
Address [1] 263771 0
Country [1] 263771 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266634 0
Gold Coast Health Service District
Ethics committee address [1] 266634 0
c/o 8 Little High Street
Southport QLD 4215
Ethics committee country [1] 266634 0
Australia
Date submitted for ethics approval [1] 266634 0
Approval date [1] 266634 0
01/03/2011
Ethics approval number [1] 266634 0
10/QGC/87

Summary
Brief summary
Specific aims of this research project include:
1.Examining whether previous findings about associations between illness representations and health related quality of life in people who have had a traumatic injury are replicated.
2.The development and evaluation of a brief CBT intervention designed to enhance self-regulation in trauma injured patients and assist them to develop realistic and helpful cognitive representations which would in turn facilitate their coping and recovery processes.

It is hypothesized that:
1.Illness perceptions will be associated with health-related quality of life.
2.Following the intervention, the intervention group will show more adaptive illness perceptions than the control group.
3.Following the intervention, the intervention group will report better health-related quality of life than the control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32328 0
Address 32328 0
Country 32328 0
Phone 32328 0
Fax 32328 0
Email 32328 0
Contact person for public queries
Name 15575 0
Jamie Barnier
Address 15575 0
School of Psychology
Gold Coast Campus
Griffith University
Southport QLD
4222
Country 15575 0
Australia
Phone 15575 0
+61 0419 199 259
Fax 15575 0
Email 15575 0
[email protected]
Contact person for scientific queries
Name 6503 0
Jamie Barnier
Address 6503 0
School of Psychology
Gold Coast Campus
Griffith University
Southport QLD
4222
Country 6503 0
Australia
Phone 6503 0
+61 0419 199 259
Fax 6503 0
Email 6503 0
[email protected]

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
No additional documents have been identified.