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Trial registered on ANZCTR


Registration number
ACTRN12608000298314
Ethics application status
Approved
Date submitted
7/06/2008
Date registered
16/06/2008
Date last updated
16/06/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomized controlled trial of augmented cognitive behaviour therapy for reduction of posttraumatic stress disorder symptoms
Scientific title
Randomized controlled trial of augmented cognitive behaviour therapy for reduction of posttraumatic stress disorder symptoms
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder 3242 0
Condition category
Condition code
Mental Health 3406 3406 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Augmented cognitive behaviour therapy involves 12 once-weekly sessions of individual therapy over 12 weeks. The therapy includes 4 sessions of emotion regulation skills training followed by 8 sessions of reliving of trauma memories and re-appraisal of beliefs about the traumatic experience.
Intervention code [1] 2983 0
Treatment: Other
Comparator / control treatment
Cognitive behaviour therapy involves 12 once-weekly sessions of individual therapy over 12 weeks. The therapy includes 4 sessions of supportive counseling followed by 8 sessions of reliving of trauma memories and re-appraisal of beliefs about the traumatic experience.
Control group
Active

Outcomes
Primary outcome [1] 4304 0
Postttraumatic stress disorder symptoms assessed by the Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale
Timepoint [1] 4304 0
Pretreatment, posttreatment, 6-month follow-up
Secondary outcome [1] 7251 0
Depression measured by the Beck Depression Inventory
Timepoint [1] 7251 0
Pretreatment, posttreatment, 6-month follow-up

Eligibility
Key inclusion criteria
(1) Exposure to trauma, (2) Meet criteria for PTSD
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Suicidal risk, 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. Patients 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 centre.
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
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
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3466 0
Government body
Name [1] 3466 0
National Health & Medical Research Council
Address [1] 3466 0
School of Psychology, University of New South Wales, NSW, 2052
Country [1] 3466 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
University of New South Wales, Sydney, NSW, 2052
Country
Australia
Secondary sponsor category [1] 3111 0
Hospital
Name [1] 3111 0
Westmead Hospital
Address [1] 3111 0
Westmead Hospital, O'Briens Road, Westmead, NSW, 2145.
Country [1] 3111 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5497 0
Sydney West Area health Service Human Research Ethics Committee
Ethics committee address [1] 5497 0
Westmead Hospital, O'Briens Road, Westmead, NSW, 2145.
Ethics committee country [1] 5497 0
Australia
Date submitted for ethics approval [1] 5497 0
Approval date [1] 5497 0
08/06/2006
Ethics approval number [1] 5497 0
HREC2004/7/4.16

Summary
Brief summary
This trial will randomly allocate patients with PTSD to either standard cognitive behaviour therapy or augmented cognitive behaviour therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28653 0
Address 28653 0
Country 28653 0
Phone 28653 0
Fax 28653 0
Email 28653 0
Contact person for public queries
Name 11810 0
Professor Richard Bryant
Address 11810 0
School of Psychology, University of New South Wales, Sydney, NSW, 2052.
Country 11810 0
Australia
Phone 11810 0
02-93853640
Fax 11810 0
02-93853641
Email 11810 0
r.bryant@unsw.edu.au
Contact person for scientific queries
Name 2738 0
Professor Richard Bryant
Address 2738 0
School of Psychology, University of New South Wales, Sydney, NSW, 2052.
Country 2738 0
Australia
Phone 2738 0
02-93853640
Fax 2738 0
02-93853641
Email 2738 0
r.bryant@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary