Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000017022
Ethics application status
Approved
Date submitted
6/01/2010
Date registered
7/01/2010
Date last updated
7/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of Exposure and Cognitive Restructuring for Reduction in Posttraumatic Stress Disorder (PTSD) Symptoms
Scientific title
Randomised Controlled Trial of Exposure and Cognitive Restructuring for Reduction in Posttraumatic Stress Disorder (PTSD) Symptoms After Exposure to Any Traumatic Event
Secondary ID [1] 1242 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder 256476 0
Condition category
Condition code
Mental Health 256646 256646 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are 4 arms to this trial. Arm 1: Imaginal Exposure only. Arm 2: In Vivo Exposure only. Arm 3: Imaginal Exposure and In Vivo Exposure combined. Arm 4: Imaginal Expsoure, In Vivo Exposure and Cognitive Restructuring combined. Therapy is administered in once-weekly 90-minute sessions of one-on-one therapy with a clinical psychologist over 8 weeks. Imaginal exposure includes imaginal reliving of trauma memories. In vivo exposure includes gradual exposure to feared situations. Cognitive restructuring includes training reappraisal 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] 255761 0
Treatment: Other
Comparator / control treatment
The Imaginal Exposure condition involves 8 once-weekly 90-minute sessions of individual therapy over 8 weeks. The therapy includes imaginal reliving of trauma memories. The In Vivo Exposure condition involves 8 once-weekly 90-minute sessions of individual therapy over 8 weeks. The therapy includes gradual exposure to feared situations. The Imaginal Exposure/In Vivo Exposure Condition involves 8 once-weekly 90-minute sessions of individual therapy over 8 weeks. The therapy includes imaginal reliving of trauma memories and gradual exposure to feared situations. 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] 257539 0
Posttraumatic stress disorder as measured by the Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale
Timepoint [1] 257539 0
Pretreatment, Posttreatment, 6-Month Follow-Up
Secondary outcome [1] 262777 0
Depression as measured by the Beck Depression Inventory
Timepoint [1] 262777 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
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
Completed
Date of first participant enrolment
Anticipated
1/03/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
118
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256246 0
Government body
Name [1] 256246 0
National Health & Medical Research Council
Country [1] 256246 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] 251577 0
Hospital
Name [1] 251577 0
Westmead Hospital
Address [1] 251577 0
Westmead Hospital O'Briens Road Westmead, NSW, 2145
Country [1] 251577 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258340 0
Sydney West Area Health Service Human Ethics Committee
Ethics committee address [1] 258340 0
Westmead Hospital O'Briens Road Westmead, NSW, 2145
Ethics committee country [1] 258340 0
Australia
Date submitted for ethics approval [1] 258340 0
Approval date [1] 258340 0
12/12/2004
Ethics approval number [1] 258340 0
HREC2004/7/4.16 (1883)

Summary
Brief summary
This study will randomly allocate patients with PTSD to either (a) imaginal exposure, (b) in vivo exposure, (c) combined imaginal and in vivo exposure, or (d) combined imaginal, in vivo exposure, and cognitive restructuring.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30665 0
Address 30665 0
Country 30665 0
Phone 30665 0
Fax 30665 0
Email 30665 0
Contact person for public queries
Name 13912 0
Professor Richard Bryant
Address 13912 0
School of Psychology
University of New South Wales
Sydney, NSW, 2052
Country 13912 0
Australia
Phone 13912 0
61-2-93853640
Fax 13912 0
61-2-93853641
Email 13912 0
[email protected]
Contact person for scientific queries
Name 4840 0
Professor Richard Bryant
Address 4840 0
School of Psychology
University of New South Wales
Sydney, NSW, 2052
Country 4840 0
Australia
Phone 4840 0
61-2-93853640
Fax 4840 0
61-2-93853641
Email 4840 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.