Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000296336
Ethics application status
Approved
Date submitted
21/05/2008
Date registered
13/06/2008
Date last updated
13/06/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of Cognitive Behaviour Therapy to Reduce Posttraumatic Stress Disorder Symptoms After Terrorist Attacks in Thailand
Scientific title
Randomised Controlled Trial of Cognitive Behaviour Therapy to Reduce Posttraumatic Stress Disorder Symptoms After Terrorist Attacks in Thailand
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder 3175 0
Condition category
Condition code
Mental Health 3334 3334 0 0
Anxiety
Mental Health 3335 3335 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cogntive behaviour therapy involves 8 x 60 minute sessions of individual therapy provided on a a once-weekly basis that lasts 8 weeks. The therapy includes exposure to trauma memories and re-appraisal of beliefs about the trauma.
Intervention code [1] 2908 0
Treatment: Other
Comparator / control treatment
Treatment as usual, which will involve counseling and management of symptoms through supportive care. This therapy involves 8 x 60 minute sessions of individual therapy provided on a a once-weekly basis that lasts 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 4223 0
Posttraumatic Stress Disorder Scale
Timepoint [1] 4223 0
Pretreatment, posttreatment, and 3 month follow-up
Secondary outcome [1] 7139 0
Beck Depression Inventory
Timepoint [1] 7139 0
Pretreatment, posttreatment, and 3 month follow-up

Eligibility
Key inclusion criteria
Meet DSM-IV criteria for Posttraumatic Stress Disorder: (a) exposed to a terrorist attack, (b) reexperiencing criteria, (c) avoidance criteria, (d) arousal criteria, (e) lasting at least 1 month, and (f) causes impairment.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Suicidal risk, psychotic

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)
Randomization will be conducted by personnel in the Department of Mental Health who are independent of clinicians based on random number generation.
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 and severity of posttraumatic stress disorder.
Masking / blinding
Blinded (masking 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
Recruiting
Date of first participant enrolment
Anticipated
1/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 977 0
Thailand
State/province [1] 977 0

Funding & Sponsors
Funding source category [1] 3412 0
Government body
Name [1] 3412 0
Australia-Thailand Institute
Country [1] 3412 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] 3056 0
Government body
Name [1] 3056 0
Department of Mental Health
Address [1] 3056 0
Department of Mental Health
Ministry of Health
Bangkok, Thailand
Country [1] 3056 0
Thailand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5438 0
Department of Mental Health
Ethics committee address [1] 5438 0
Ethics committee country [1] 5438 0
Thailand
Date submitted for ethics approval [1] 5438 0
Approval date [1] 5438 0
14/03/2007
Ethics approval number [1] 5438 0

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

Contacts
Principal investigator
Name 28605 0
Address 28605 0
Country 28605 0
Phone 28605 0
Fax 28605 0
Email 28605 0
Contact person for public queries
Name 11762 0
Prof Richard Bryant
Address 11762 0
Schoolof Psychology
University of New South Wales
Sydney, NSW, 2052
Country 11762 0
Australia
Phone 11762 0
61-2-93854640
Fax 11762 0
61-2-93854640
Email 11762 0
[email protected]
Contact person for scientific queries
Name 2690 0
Prof Richard Bryant
Address 2690 0
School of Psychology
University of New South Wales
Sydney, NSW, 2052
Country 2690 0
Australia
Phone 2690 0
61-2-93854640
Fax 2690 0
61-2-93854641
Email 2690 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.