Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000355572
Ethics application status
Not yet submitted
Date submitted
20/07/2014
Date registered
20/04/2015
Date last updated
20/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Hospital-Based Early Intervention for Posttraumatic Stress Disorder
Scientific title
Randomised Controlled Trial of Cognitive Therapy with either Memory Reactivation or Control Condition for Adults to prevent Posttraumatic Stress Disorder Following Traumatic Injury
Secondary ID [1] 285019 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder 292533 0
Condition category
Condition code
Mental Health 292839 292839 0 0
Anxiety
Injuries and Accidents 295045 295045 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 289853 0
Treatment: Other
Intervention code [2] 291628 0
Prevention
Comparator / control treatment
Cognitive Therapy includes brief 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.

Wait-List includes no intervention but involves same assessments as administered to those in active treatments. 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. At the conclusion of the Wait-List follow-up, participants in this condition will be referred for individual treatment as indicated.
Control group
Active

Outcomes
Primary outcome [1] 292706 0
Posttraumatic stress disorder, as measured by the Posttraumatic Stress Scale.
Timepoint [1] 292706 0
Timepoint: Pretreatment, posttreatment, 3, Month Follow-up, 6-Month Follow-up
Secondary outcome [1] 309529 0
Depression, as measured by the Hospital Anxiety and Depression Scale
Timepoint [1] 309529 0
Timepoint: Pretreatment, posttreatment, 3, Month Follow-up, 6-Month Follow-up

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be adults admitted to hospital following traumatic injury and indicating moderate distress. Participants wishing to participate will be randomly allocated according to
a random numbers system administered by an individual who
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 minmization stratified on gender and severity of PTSD levels.
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
The thrust of analyses will be using hierarchical linear models (HLM) to investigate the relative effects of the treatments. Analyses will be conducted using Mplus (version 7.11). The benefit of this approach is that it presumes intent-to-treat analyses as HLM allows the number of observations to vary between participants and effectively handles missing data by using the maximum likelihood estimator, which provides the optimal estimates of model parameter values and standard errors. The Level 1 model will represent within-patient change over time, and the Level 2 model will predict variation in within-patient change over time and encompass between-patient variables (treatment condition, injury characteristics, gender). Primary measures will comprise the PDS and HADS. Effect size is based on previous recommendations for multilevel models. Power for this design is estimated to be 80%, entering the parameters of 80 per group, effect-size at .7 (p = .05).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2016
Actual
Date of last participant enrolment
Anticipated
1/11/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2755 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 8454 0
2065 - Crows Nest

Funding & Sponsors
Funding source category [1] 289632 0
Government body
Name [1] 289632 0
NHMRC
Country [1] 289632 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
School of Psychology, University of New South Wales, Anzac Parade, Kensington, Sydney, NSW, 2052
Country
Australia
Secondary sponsor category [1] 288318 0
None
Name [1] 288318 0
Address [1] 288318 0
Country [1] 288318 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291371 0
Northern Sydney Local Area Health Service HREC
Ethics committee address [1] 291371 0
Ethics committee country [1] 291371 0
Australia
Date submitted for ethics approval [1] 291371 0
28/07/2014
Approval date [1] 291371 0
Ethics approval number [1] 291371 0

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

Contacts
Principal investigator
Name 50086 0
Prof Richard Bryant
Address 50086 0
School of Psychology University of New South Wales Sydney, NSW, 2052
Country 50086 0
Australia
Phone 50086 0
+61-2-93853640
Fax 50086 0
+61-2-93853641
Email 50086 0
[email protected]
Contact person for public queries
Name 50087 0
Richard Bryant
Address 50087 0
School of Psychology University of New South Wales Sydney, NSW, 2052
Country 50087 0
Australia
Phone 50087 0
+61-2-93853640
Fax 50087 0
+61-2-93853641
Email 50087 0
[email protected]
Contact person for scientific queries
Name 50088 0
Richard Bryant
Address 50088 0
School of Psychology University of New South Wales Sydney, NSW, 2052
Country 50088 0
Australia
Phone 50088 0
+61-2-93853640
Fax 50088 0
+61-2-93853641
Email 50088 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.