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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12615000355572 |
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Date of registration:
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20/04/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Hospital-Based Early Intervention for Posttraumatic Stress Disorder
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Scientific title:
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Randomised Controlled Trial of Cognitive Therapy with either Memory Reactivation or Control Condition for Adults to prevent Posttraumatic Stress Disorder Following Traumatic Injury |
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Date of first enrolment:
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01/01/2016 |
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Target sample size:
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240 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://anzctr.org.au/ACTRN12615000355572.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Prof Richard Bryant
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Address:
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School of Psychology University of New South Wales Sydney, NSW, 2052
Australia |
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Telephone:
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+61-2-93853640 |
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Email:
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r.bryant@unsw.edu.au |
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Affiliation:
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Name:
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Prof Richard Bryant
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Address:
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School of Psychology University of New South Wales Sydney, NSW, 2052
Australia |
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Telephone:
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+61-2-93853640 |
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Email:
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r.bryant@unsw.edu.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Adults survivors of traumatic injury who are admitted to hospital following injury and report at least moderate distress (as measured on the Acute Stress Disorder Scale)
Exclusion criteria: (a) current substance dependence, (b) inadequate comprehension of English, (c) suicidal intent, (d) psychosis, (e) concurrent psychotropic medication, (f) concurrent psychotherapy, or (g) existence of moderate or severe traumatic brain injury.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Posttraumatic stress disorder;
Posttraumatic stress disorder
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Injuries and Accidents - Other injuries and accidents
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Mental Health - Anxiety
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Intervention(s)
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There are three arms to this trial. Arm 1: Cognitive Therapy/Memory Reactivation. Arm 2: Cognitive Therapy. Arm 3: Wait-List. Therapy is administered once-daily over
4 days on an individual 30 minute basis. Cognitive Therapy/Memory Reactivation is hospital-based and administered by a psychologist. It includes brief reminding the patient of their traumatic injury, followed by audiorecorded instructions encouraging adaptive appraisals about recovery. The duration of the study for any participant will conclude after a 6-month follow-up assessment, resulting in participation duration of 6.5 months.
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Primary Outcome(s)
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Posttraumatic stress disorder, as measured by the Posttraumatic Stress Scale.[Timepoint: Pretreatment, posttreatment, 3, Month Follow-up, 6-Month Follow-up]
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Secondary Outcome(s)
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Depression, as measured by the Hospital Anxiety and Depression Scale[Timepoint: Pretreatment, posttreatment, 3, Month Follow-up, 6-Month Follow-up]
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Source(s) of Monetary Support
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NHMRC
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Ethics review
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Status: Not approved
Approval date:
Contact:
Northern Sydney Local Area Health Service HREC
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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