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Trial registered on ANZCTR


Registration number
ACTRN12607000088448
Ethics application status
Approved
Date submitted
19/09/2006
Date registered
25/01/2007
Date last updated
11/12/2018
Date data sharing statement initially provided
11/12/2018
Date results provided
11/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Promoting Recovery Following Traumatic Injury
Scientific title
Screening and treating posttraumatic stress, depression and anxiety with early trauma focused cognitive behavioural therapy following traumatic injury
Secondary ID [1] 296847 0
Nil known
Secondary ID [2] 296848 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress symptoms 1581 0
Posttraumatic stress disorder (PTSD) 1582 0
Depression 1583 0
Anxiety 1584 0
Condition category
Condition code
Mental Health 1685 1685 0 0
Anxiety
Mental Health 1686 1686 0 0
Depression
Mental Health 1687 1687 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention trialled in this study is trauma focused cognitive behavioural therapy (TF-CBT). Participants in this group are offered this treatment 4-6 weeks post injury (early intervention condition). This intervention is delivered on a session basis (one to two sessions per week) for a period of 6-10 sessions. Each session has a duration of 90 minutes. The intervention in this study, TF-CBT, involves psychoeducation around psychological symptoms and trauma, anxiety management, exposure to feared thoughts and situations, cognitive therapy for identifying and challenging maladaptive thought processes around trauma, activity and positive event scheduling and relapse prevention. The administration of these modules in the therapy are tailored for the particular presentation of symptoms. For example, if the presentation is primarily comprised of depressive symptoms, an emphasis on activity and positive events is made. Likewise if the presentation comprises primarliy of PTSD symptoms, an emphasis on prolongued exposure is made.
Intervention code [1] 1364 0
Behaviour
Comparator / control treatment
The intervention trialled in this study is trauma focused cognitive behavioural therapy (TF-CBT). Participants in this group will be offered this treatment 16 weeks post injury (later intervention condition). This intervention is delivered on a session basis (one to two sessions per week) for a period of 6-10 sessions. Each session has a duration of 90 minutes. The late intervention comparison group will act as a waitlist control/treatment as usual condition and will be compared with the early intervention condition to inform of the effectiveness of early intervention.
Control group
Active

Outcomes
Primary outcome [1] 2334 0
The Postrauma Adjustment Scale (PAS) and the Trauma Screening Questionnaire (TSQ) will be administered.
Timepoint [1] 2334 0
Time point 1 (1-2 weeks post injury).
Primary outcome [2] 2335 0
The Postramatic Stress Checklist (PCL) and the Hospital Anxiety and Depression Scale (HADS) will be administered to participants screened as high at Timepoint 1 measures.
Timepoint [2] 2335 0
Timepoint 2 (4-6 weeks post injury).
Primary outcome [3] 2336 0
The Clinican Administred PTSD Scale (CAPS) and the Multi International Neuropsychiatric Interview (MINI) will be administered. This timepoint also acts as the pre-test assessment prior to therapy (intervention) for those assessed as high on the CAPS and MINI. This assessment is completed, irrespective of whether participants undertake therapy. A range of self report measures are also administered at this timepoint as primary outcome measures. These include: Demographic Information, World Health Organistaion Quality of Life measure (WHOQOL), the World Health Organisation Disability Scale (WHODAS), the Alcohol Use Identification Test (AUDIT), the Beck Depression Inventory (BDI), the Hospital Anxiety and Depression Scale (HADS), the Survey of Pain Attitudes (SPA), the West Haven-Yale Multidimensional Pain Inventory (WHYMPI), and the Family Relationship Scale.
Timepoint [3] 2336 0
Timepoint 3 (6 weeks post injury).
Primary outcome [4] 2337 0
The CAPS, MINI and self report measures described above are administered again. This assessment acts as a post test assesment for those in the early intervention group. Whilst serving as the comparison time point this assesment acts as both a 'posttest' comparison and pretest for those participants waiting to undertake the later intervention.
Timepoint [4] 2337 0
Timepoint 4 (18 weeks post therapy).
Primary outcome [5] 2338 0
The CAPS, MINI and self report measures described above are administered again at this timepoint.
Timepoint [5] 2338 0
Timepoint 5 (6 months post injury).
Timepoint 6 (12 months post injury).
Secondary outcome [1] 4070 0
The Refusal Questionaire (applicable for participants who decline/withdraw participation in study)
Timepoint [1] 4070 0
administered at Timepoint 1 (1-2 weeks post injury), Timepoint 2 (4-6 weeks post injury), Timepoint 3 (6 weeks post injury), Timepoint 4 (18 weeks post injury), Timepoint 5 (6 months post injury) and Timepoint 6 (12 months post injury).
Secondary outcome [2] 4071 0
Health service usage and cost
Timepoint [2] 4071 0
measured at Timepoint 3, 4, 5 and 6.

Eligibility
Key inclusion criteria
Inclusion- a) A patient with physical injury that requires an admission of at least 24 hours to the trauma service. b) No brain injury or Mild Traumatic Brain Injury.c) Age between 16 and 65 years (parental consent for <18).d) A reasonable comprehension of English (defined by proficiency to read and understand the participant information sheet and consent form).
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion:a) Non traumatic injury – defined as patients with an injury that is minor and caused by a non-traumatic event. This includes minor injury sustained by the following mechanisms of injury:• Falling from a non-height (e.g., tripping, slipping, fainting)• Domestic accidents (accidents that occur around the home)• Sporting injuries b) Deathc) Age >65 or <16d) Satellite admission – in some cases patients are kept in wards for observation, usually because their injuries are relatively minor. Those in observation wards are not included in the study.e) Brain injury is greater than mild f) The injury is a result of deliberate self-harm g) The individual has a history of or current psychotic disorderh) A temporary Australian visitor (e.g., tourist)i) Non English speakerj) Admission <24 hoursk) Actively suicidall) Cognitive impairmentm) Under police guardn) Missed patients

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)
A sealed opaque envelope will be provided by an external researcher to the clinican before the Time 3 assesment is undertaken. At cessation of the Time 3 assessment, which determines eligibility to the treatment trial, the clinican will open the envelope that will inform which treatment allocation (early or late) the participant has been allocated. The clinican in the study will determine inclusion eligibility to the treatment trial. This clinician will be unaware to which group the participant has been allocated till it is revealled via the envelope after the determination for eligibility into the treatment has been made.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation will be utilised in this study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
While neither the clinican administering the treatment nor the participant recieving treatment is blind to the treatment condition to which the participant is allocated, researchers who conduct the post test (post therapy) and follow assessments are blind to the treatment allocation of the participant.
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2006
Actual
11/10/2006
Date of last participant enrolment
Anticipated
Actual
3/07/2008
Date of last data collection
Anticipated
Actual
29/05/2009
Sample size
Target
1000
Accrual to date
Final
683
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12697 0
The Alfred - Prahran
Recruitment hospital [2] 12698 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 25117 0
3181 - Prahran
Recruitment postcode(s) [2] 25118 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 1829 0
Charities/Societies/Foundations
Name [1] 1829 0
Victorian Trauma Foundation (VTF)
Country [1] 1829 0
Australia
Primary sponsor type
University
Name
Australian Centre for Posttraumatic Mental Health (ACPMH), Dpt of Psychiatry, University of Melbourne
Address
VIC
Country
Australia
Secondary sponsor category [1] 1648 0
Hospital
Name [1] 1648 0
Alfred and Royal Melbourne Hospitals (Trauma and Psychiatry departments)
Address [1] 1648 0
Vic
Country [1] 1648 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3424 0
Alfred Hospital
Ethics committee address [1] 3424 0
Ethics committee country [1] 3424 0
Australia
Date submitted for ethics approval [1] 3424 0
Approval date [1] 3424 0
23/02/2006
Ethics approval number [1] 3424 0
30/06
Ethics committee name [2] 3425 0
Royal Melbourne Hospital
Ethics committee address [2] 3425 0
Ethics committee country [2] 3425 0
Australia
Date submitted for ethics approval [2] 3425 0
Approval date [2] 3425 0
01/03/2006
Ethics approval number [2] 3425 0
2006.008

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

Contacts
Principal investigator
Name 27591 0
Prof Meaghan O'Donnell
Address 27591 0
Phoenix Australia - Centre for Posttraumatic Mental Health
Department of Psychiatry, University of Melbourne
Level 3, Alan Gilbert Building, 161 Barry Street
Carlton VIC 3053
Country 27591 0
Australia
Phone 27591 0
+61 3 9035 5599
Fax 27591 0
+61 3 9035 5455
Email 27591 0
mod@unimelb.edu.au
Contact person for public queries
Name 10553 0
Winnie Lau
Address 10553 0
Phoenix Australia - Centre for Posttraumatic Mental Health
Department of Psychiatry, University of Melbourne
Level 3, Alan Gilbert Building, 161 Barry Street
Carlton VIC 3053
Country 10553 0
Australia
Phone 10553 0
+61 3 9035 5599
Fax 10553 0
+61 3 9035 5455
Email 10553 0
wlau@unimelb.edu.au
Contact person for scientific queries
Name 1481 0
Professor Meaghan O'Donnell
Address 1481 0
Phoenix Australia - Centre for Posttraumatic Mental Health
Department of Psychiatry, University of Melbourne
Level 3, Alan Gilbert Building, 161 Barry Street
Carlton VIC 3053
Country 1481 0
Australia
Phone 1481 0
+61 3 9035 5599
Fax 1481 0
+61 3 9035 5455
Email 1481 0
mod@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data not available.


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.