Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000391471
Ethics application status
Approved
Date submitted
23/07/2007
Date registered
31/07/2007
Date last updated
31/07/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cognitive Behaviour Therapy of Acute Stress Disorder
Scientific title
A randomised controlled trial to evaluate the effect of prolonged exposure versus cognitive restructuring versus wait-list to prevent posttraumatic stress disorder
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute stress disorder (ASD) 2189 0
Condition category
Condition code
Mental Health 2284 2284 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention comprises prolonged exposure or cognitive restructuring. Participants are given 5 weekly 90-minute sessions of prolonged exposure (imaginal exposure and in vivo exposure) or 5 weekly 90-minute sessions of cognitive restructuring. Exposure involves repeating trauma memories. Cognitive restructuring involves identification and correction of irrational thoughts.
Intervention code [1] 1905 0
Behaviour
Comparator / control treatment
The control condition involves patients in the wait list being assessed before treatment and re-assessed 6 weeks later.
Control group
Active

Outcomes
Primary outcome [1] 3175 0
Severity of posttraumatic stress symptoms measured by the Clinician Adminsitered PTSD Scale
Timepoint [1] 3175 0
At baseline, posttreatment ,and 6 months after treatment.
Secondary outcome [1] 5297 0
Depression (measured by the Beck Depression Inventory)
Timepoint [1] 5297 0
Assessed at posttreatment and 6 months after treatment finishes.
Secondary outcome [2] 5298 0
Anxiety (measured by the Beck Anxiety Inventory)
Timepoint [2] 5298 0
Assessed at posttreatment and 6 months after treatment finishes.

Eligibility
Key inclusion criteria
Inclusion criteria were that the patient had suffered a motor vehicle accident or nonsexual assault in the previous month and met full criteria for ASD.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included history of psychosis, organic brain syndrome, current substance dependence, borderline personality disorder, suicidal risk, inability to converse in English, or aged less than 17 years of age or more than 70 years of age.

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 to treatment condition is conducted by a clinician via email who is independent of the study and the hospital site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generation with stratification by ASD severity, gender, and type of trauma.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All assessors are blind to treatment condition
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2450 0
Government body
Name [1] 2450 0
National Health and Medical Research Council
Country [1] 2450 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 2222 0
None
Name [1] 2222 0
None
Address [1] 2222 0
Country [1] 2222 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4304 0
University of New South Wales Committee on Experimental Procedures Involving Human Ethics
Ethics committee address [1] 4304 0
Ethics committee country [1] 4304 0
Australia
Date submitted for ethics approval [1] 4304 0
Approval date [1] 4304 0
20/07/1999
Ethics approval number [1] 4304 0
CEPIHS No. 99136

Summary
Brief summary
Acute Stress Disorder is a psychiatric condition that develops after exposure to a traumatic event, and is strongly predictive of subsequent disorder. Although cognitive behaviour therapy effectively treats ASD, little is known about the optimal intervention strategies for treating ASD. This study will compare 5 weekly sessions of either prolonged exposure, cognitive restructuring, or wait -list to determine the relative efficacies in reducing posttraumatic stress disorder at 6 months follow-up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27719 0
Address 27719 0
Country 27719 0
Phone 27719 0
Fax 27719 0
Email 27719 0
Contact person for public queries
Name 11094 0
Professor Richard Bryant
Address 11094 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 11094 0
Australia
Phone 11094 0
+61 2 93853640
Fax 11094 0
+61 2 93853641
Email 11094 0
[email protected]
Contact person for scientific queries
Name 2022 0
Professor Richard Bryant
Address 2022 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 2022 0
Australia
Phone 2022 0
+61 2 93853640
Fax 2022 0
+61 2 93853641
Email 2022 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.