Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000426088
Ethics application status
Not yet submitted
Date submitted
22/05/2010
Date registered
26/05/2010
Date last updated
26/05/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of Cognitive Behavior Therapy and Supportive Counselling for Reduction in Posttraumatic Stress Disorder (PTSD) Symptoms in Refugees
Scientific title
Randomised Controlled Trial of Cognitive Behavior Therapy and Supportive Counselling for Reduction in Posttraumatic Stress Disorder (PTSD) Symptoms in Refugees
Secondary ID [1] 251838 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder 257438 0
Condition category
Condition code
Mental Health 257587 257587 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are 2 arms to this trial. Arm 1:Cognitive Behaviour Therapy. Arm 2: Supportive Counselling. Therapy is administered in once-weekly 90-minute sessions of one-on-one therapy with a clinical psychologist over 8 weeks. Cognitive Behaviour Therapy includes imaginal reliving of trauma memories, in vivo exposure that includes gradual exposure to feared situations, and cognitive restructuring of the trauma experience. The duration of the study for any participant will conclude after the 6-month follow-up assessment, resulting in participation duration of 8 months.
Intervention code [1] 256536 0
Behaviour
Intervention code [2] 256554 0
Other interventions
Comparator / control treatment
The Supportive Counselling condition involves 8 once-weekly 90-minute sessions of individual therapy over 8 weeks. The therapy includes nondirective counselling that does not include any Cognitive Behaviour Therapy components. The duration of the study for any participant will conclude after the 6-month follow-up assessment, resulting in participation duration of 8 months.
Control group
Active

Outcomes
Primary outcome [1] 258505 0
Posttraumatic stress disorder as measured by the Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale
Timepoint [1] 258505 0
Pretreatment, Posttreatment, 6-Month Follow-Up
Secondary outcome [1] 264306 0
Depression as measured by the Beck Depression Inventory
Timepoint [1] 264306 0
Pretreatment, Posttreatment, 6-Month Follow-Up

Eligibility
Key inclusion criteria
(1) Exposure to refugee-related trauma, (2) Meet criteria for PTSD
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Suicidal intent, psychotic, substance dependent

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)
Participants will be treatment seeking patients attending the Traumatic Stress Clinic at Westmead Hospital. Participants will be randomly assigned according to a random numbers system administered by an individual who is independent of the study and who works at a site that is distant from the treatment center.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be conducted by a process of minimization stratified on gender, trauma type, and Posttraumatic Stress Disorder severity.
Masking / blinding
Blinded (masking 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
1/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257026 0
Government body
Name [1] 257026 0
National Health & Medical Research Council (NHMRC)
Country [1] 257026 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
School of Psychology, University of New South Wales, Anzac Parade, Kensington, Sydney, NSW, 2052
Country
Australia
Secondary sponsor category [1] 256282 0
Hospital
Name [1] 256282 0
Westmead Hospital
Address [1] 256282 0
Westmead Hospital, O'Briens Road Westmead, NSW, 2145
Country [1] 256282 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259041 0
Ethics committee address [1] 259041 0
Ethics committee country [1] 259041 0
Date submitted for ethics approval [1] 259041 0
01/07/2010
Approval date [1] 259041 0
Ethics approval number [1] 259041 0

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

Contacts
Principal investigator
Name 31208 0
Address 31208 0
Country 31208 0
Phone 31208 0
Fax 31208 0
Email 31208 0
Contact person for public queries
Name 14455 0
Professor Richard Bryant
Address 14455 0
School of Psychology
University of New South Wales, Anzac Parade, Kensington,
Sydney, NSW, 2052
Country 14455 0
Australia
Phone 14455 0
61-2-93853640
Fax 14455 0
61-2-93853641
Email 14455 0
[email protected]
Contact person for scientific queries
Name 5383 0
Professor Richard Bryant
Address 5383 0
School of Psychology
University of New South Wales, Anzac Parade, Kensington,
Sydney, NSW, 2052
Country 5383 0
Australia
Phone 5383 0
61-2-93853640
Fax 5383 0
61-2-93853641
Email 5383 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.