Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000438550
Ethics application status
Approved
Date submitted
23/04/2015
Date registered
7/05/2015
Date last updated
7/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Ongoing Treatment of Posttraumatic Stress Disorder After Traumatic Injury
Scientific title
Randomised Controlled Trial of Enhanced Monitoring or Treatment As Usual for Adults to Treat Posttraumatic
Stress Disorder Following Traumatic Injury
Secondary ID [1] 286588 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder 294860 0
Condition category
Condition code
Mental Health 295119 295119 0 0
Anxiety
Injuries and Accidents 295120 295120 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two arms to this trial. Arm 1: Enhanced Monitoring. Arm 2: Treatment as Usual. Enhanced Monitoring involves patients being assessed by telephone after hospital discharge at 1, 3, and 9 months by a psychologist, and if patient indicates psychological problems they are referred to local specialists for treatment. Treatment as Usual involves being assessed by telephone by a psychologist at 1, 3, and 9 months but there is no specific referrals. The duration of the study for any participant will conclude after the 9-month follow-up assessment, resulting in participation duration of 9.5 months.
Intervention code [1] 291703 0
Treatment: Other
Comparator / control treatment
Treatment as Usual includes follow-up assessments at 1, 3, and 9 months following hospital discharge. At the 9 month assessment patients will be sent to specialist referral if needed. The duration of the study for any participant will conclude after the 9-month follow-up assessment, resulting in participation duration of 9.5 months.
Control group
Active

Outcomes
Primary outcome [1] 294884 0
Posttraumatic stress disorder as measured by the Posttraumatic Stress
Scale.
Timepoint [1] 294884 0
Posttreatment (Hospital Assessment), 1 month follow up, 3 month follow up, 9 month follow up.
Secondary outcome [1] 314282 0
Anxiety, as measured by the Hospital Anxiety and Depression Scale.
Timepoint [1] 314282 0
Posttreatment (Hospital Assessment), 1 month follow up, 3 month follow up, 9 month follow up.
Secondary outcome [2] 335781 0
Disability, as measured by the World Health Organisation Disability Assessment Schedule (WHODAS)
Timepoint [2] 335781 0
The time points at which WHODAS is assessed is the Posttreatment (Hospital Assessment), 1 month follow-up, 3 month follow-up, 9 month follow up.
Secondary outcome [3] 335782 0
Depression, as measured by the Hospital Anxiety and Depression Scale (HADS)
Timepoint [3] 335782 0
The HADS will be measured as part of the Posttreatment (Hospital Assessment), 1-month month follow-up, 3 month follow-up, 9 month follow-up.

Eligibility
Key inclusion criteria
Adults survivors of traumatic injury who are admitted to hospital following injury
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with a moderate to severe traumatic brain injury as defined by
a. A GCS score < 12 – as per the Emergency Department (ED) assessment
b. Ongoing Post Traumatic Amnesia (PTA) testing > 72 hours
c. NOTE: Refer to MTBI decision making tree (appendix) if there are other reasons for altered GCS or PTA score (e.g., intubation of patient)
2. Patients unable to understand the study procedures, consent, or willingly participate in the study protocol
3. Patients with moderate dementia or severe cognitive impairment
4. Patients with severe suicidal ideation (i.e., if the injury was the result of a suicide attempt, as defined by the electronic medical records at Royal North Shore Hospital).
5. Patients with psychosis (as defined by the electronic medical records at Royal North Shore Hospital).

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 adults admitted to hospital following traumatic injury. 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?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will use repeated measures analyses of variance (ANOVAs) on intent-to-treat data (missing values imputed) using the 9 month data as the end point of analyses. Primary measures will comprise the PCL, HADS, and WHODAS. Effect sizes will be calculated between conditions at 9 months, as will number needed to treat.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2016
Actual
9/01/2017
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
31/12/2019
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3728 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 9602 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 291154 0
Government body
Name [1] 291154 0
NSW Department of Health
Country [1] 291154 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney (Northern Clinical School), Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 289832 0
None
Name [1] 289832 0
Address [1] 289832 0
Country [1] 289832 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292730 0
Northern Sydney Local Area Health Service
Ethics committee address [1] 292730 0
Ethics committee country [1] 292730 0
Australia
Date submitted for ethics approval [1] 292730 0
27/04/2015
Approval date [1] 292730 0
04/11/2015
Ethics approval number [1] 292730 0
HREC/15/HAWKE/163

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

Contacts
Principal investigator
Name 56754 0
Dr Tony Joseph
Address 56754 0
Trauma Service
Royal North Shore Hospital
St Leonards
NSW 2065
Country 56754 0
Australia
Phone 56754 0
+612 9926 7921
Fax 56754 0
+612 99265149
Email 56754 0
[email protected]
Contact person for public queries
Name 56755 0
Richard Bryant
Address 56755 0
School of Psychology, University of New South Wales, Anzac Parade, Kensington,, Sydney, NSW, 2052
Country 56755 0
Australia
Phone 56755 0
+61-2-93853640
Fax 56755 0
+61-2-93853641
Email 56755 0
[email protected]
Contact person for scientific queries
Name 56756 0
Richard Bryant
Address 56756 0
School of Psychology, University of New South Wales, Anzac Parade, Kensington,, Sydney, NSW, 2052
Country 56756 0
Australia
Phone 56756 0
+61-2-93853640
Fax 56756 0
+61-2-93853641
Email 56756 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
SourceTitleYear of PublicationDOI
EmbaseA proof-of-concept randomized controlled trial of follow-up mental health care for traumatic injury patients following hospital discharge.2023https://dx.doi.org/10.1016/j.injury.2023.01.003
N.B. These documents automatically identified may not have been verified by the study sponsor.