Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000936224
Ethics application status
Approved
Date submitted
8/10/2009
Date registered
2/11/2009
Date last updated
11/12/2018
Date data sharing statement initially provided
11/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Telephone-administered early psychological intervention for depression and anxiety following serious injury
Scientific title
Telephone-administered early psychological intervention for depression and anxiety following serious injury
Secondary ID [1] 296845 0
No secondary ID
Universal Trial Number (UTN)
Trial acronym
TAPIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder 243708 0
Anxiety 243709 0
Depression 243710 0
Condition category
Condition code
Mental Health 239975 239975 0 0
Anxiety
Mental Health 239976 239976 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention trialled in this study is telephone-administered cognitive behavioural therapy (TCBT). Participants in this study will either be offered this treatment at 4-6 weeks post injury (early intervention condition) or usual care. The active intervention (TCBT) is delivered on a session basis (one per week) for 6-10 sessions. Each session has a duration of 90 minutes.

Trauma focused cognitive behavioural therapy (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 to the particular presentation of symptoms. For example, if the presentation is primarily comprised of depressive symtpoms, emphasis on activity and positive events is made. Likewise if the presentation comprises primarily posttraumatic stress disorder (PTSD) symptoms, an emphasis on prolonged exposure is made.
Intervention code [1] 241247 0
Behaviour
Intervention code [2] 241391 0
Early detection / Screening
Comparator / control treatment
The usual care condition will receive any care that they initiate. They will be offered the TCBT at 6 months if they require it.
Control group
Active

Outcomes
Primary outcome [1] 240779 0
The Posttrauma Adjustment Scale (PAS) and the Trauma Screening Questionnaire will be administered. to screen for injury patients at high risk for developing later depression or anxiety.
Timepoint [1] 240779 0
Timepoint 1 (1-2 weeks post injury)
Primary outcome [2] 240780 0
The Posttraumatic Stress Checklist (PCL) and the Hospital Anxiety and Depression Scale (HADS) will be administered to participants who screened high on Timepoint 1 measures. THis will identify those patients who will be invited to the intervention component of the trial.
Timepoint [2] 240780 0
Timepoint 2 (4-6 weeks post injury)
Primary outcome [3] 240781 0
The Clinician Administered PTSD Scale (CAPS) and the Multi International Neuropsychiatric Interview (MINI) will be administered. A range of self report measures are also administered at this timepoint as primary outcome measures. These include:
- Demographic Information
- World Health Organisation Quality of Life measure (WHOQOL)
- World Health Organisation Disability Scale (WHODAS)
- Alcohol Use Identification Test (AUDIT)
- Beck Depression Inventory (BDI)
- Hospital Anxiety and Depression Scale (HADS)
- Survey of Pain Attitudes (SPA)
- West Haven-Yale Multidimentional Pain Inventory (WHYMPI)
- Family Relationship Scale.
Timepoint [3] 240781 0
Timepoint 3 (Pre treatment assessment)
Primary outcome [4] 240782 0
The Clinician Administered PTSD Scale (CAPS) and the Multi International Neuropsychiatric Interview (MINI) will be administered, followed by :
- World Health Organisation Quality of Life measure (WHOQOL)
- World Health Organisation Disability Scale (WHODAS)
- Alcohol Use Identification Test (AUDIT)
- Beck Depression Inventory (BDI)
- Hospital Anxiety and Depression Scale (HADS)
- Survey of Pain Attitudes (SPA)
- West Haven-Yale Multidimentional Pain Inventory (WHYMPI)
- Family Relationship Scale.
Timepoint [4] 240782 0
Timepoint 4 (6 months post injury)

Follow-up assessment 1
Primary outcome [5] 240783 0
The Clinician Administered PTSD Scale (CAPS) and the Multi International Neuropsychiatric Interview (MINI) will be administered followed by :
- World Health Organisation Quality of Life measure (WHOQOL)
- World Health Organisation Disability Scale (WHODAS)
- Alcohol Use Identification Test (AUDIT)
- Beck Depression Inventory (BDI)
- Hospital Anxiety and Depression Scale (HADS)
- Survey of Pain Attitudes (SPA)
- West Haven-Yale Multidimentional Pain Inventory (WHYMPI)
- Family Relationship Scale.
Timepoint [5] 240783 0
Timepoint 5 (12 months post injury)

Follow-up assessment 2
Secondary outcome [1] 257859 0
Nil
Timepoint [1] 257859 0
Nil

Eligibility
Key inclusion criteria
Inclusion criteria:
a) A male or female 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 (MTBI)
c) Aged between 16 and 70 years (parental consent for <18 yrs)
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
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
a) Death
b) Age >70 or <16
c) Brain injury is greater than mild
d) The injury is a result of deliberate self-harm
e) The individual has a history of or current psychotic disorder
f) A temporary Australian visitor (eg tourist)
g) Non English speaker
h) Admission <24 hours
i) Actively suicidal
j) Cognitive impairment
k) Under police guard

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)
An independant researcher will allocate participants into either condition. The therapist will contact the independant researcher when a new participant enters the intervention component of the study. The independant researcher will tell the therapist what condition the participant is in..
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation will be utilised by the independant researcher
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
While neither the clinician administering the treatment nor the participant receiving treatment is blind to the treatment condition to which the participant is allocated, researchers who conduct the follow up assessments (post therapy) are blind to the treatment allocation of the participant.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/01/2010
Actual
19/02/2010
Date of last participant enrolment
Anticipated
Actual
29/09/2011
Date of last data collection
Anticipated
Actual
30/10/2012
Sample size
Target
1000
Accrual to date
Final
775
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12695 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 12696 0
The Alfred - Prahran
Recruitment postcode(s) [1] 2073 0
3004
Recruitment postcode(s) [2] 2074 0
3050

Funding & Sponsors
Funding source category [1] 243622 0
Charities/Societies/Foundations
Name [1] 243622 0
Beyondblue
Country [1] 243622 0
Australia
Funding source category [2] 243623 0
Government body
Name [2] 243623 0
National Health and Medical Research Council
Country [2] 243623 0
Australia
Primary sponsor type
University
Name
Australian Centre for Posttraumatic Mental Health (ACPMH), Dept Psychiatry, University of Melbourne
Address
Level 1
340 Albert Street
East Melbourne
Vic 3002
Country
Australia
Secondary sponsor category [1] 237070 0
Hospital
Name [1] 237070 0
Alfred Hospital
Address [1] 237070 0
The Alfred
PO Box 315
Prahran
Vic 3181
Country [1] 237070 0
Australia
Secondary sponsor category [2] 237071 0
Hospital
Name [2] 237071 0
Royal Melbourne Hospital
Address [2] 237071 0
Grattan Street
Parkville 3050
Country [2] 237071 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243848 0
Alfred Human Research Ethics Committee
Ethics committee address [1] 243848 0
Ethics committee country [1] 243848 0
Australia
Date submitted for ethics approval [1] 243848 0
01/11/2009
Approval date [1] 243848 0
Ethics approval number [1] 243848 0
Ethics committee name [2] 243849 0
Mental Health Research and Ethics Committee
Ethics committee address [2] 243849 0
Ethics committee country [2] 243849 0
Australia
Date submitted for ethics approval [2] 243849 0
01/11/2009
Approval date [2] 243849 0
17/12/2009
Ethics approval number [2] 243849 0

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

Contacts
Principal investigator
Name 30171 0
Prof Meaghan O'Donnell
Address 30171 0
Phoenix Australia - Centre for Post traumatic Mental Health
Department of Psychiatry, University of Melbourne
Level 3, Alan Glibert Building, 161 Barry Street
Carlton VIC 3053
Country 30171 0
Australia
Phone 30171 0
+61 3 9035 5599
Fax 30171 0
+61 3 9035 5455
Email 30171 0
[email protected]
Contact person for public queries
Name 13418 0
Winnie Lau
Address 13418 0
Phoenix Australia - Centre for Post traumatic Mental Health
Department of Psychiatry, University of Melbourne
Level 3, Alan Glibert Building, 161 Barry Street
Carlton VIC 3053


Country 13418 0
Australia
Phone 13418 0
+61 3 9035 5599
Fax 13418 0
+61 3 9035 5455
Email 13418 0
[email protected]
Contact person for scientific queries
Name 4346 0
Meaghan O'Donnell
Address 4346 0
Phoenix Australia - Centre for Post traumatic Mental Health
Department of Psychiatry, University of Melbourne
Level 3, Alan Glibert Building, 161 Barry Street
Carlton VIC 3053
Country 4346 0
Australia
Phone 4346 0
+61 3 9936 5135
Fax 4346 0
+61 3 9936 5199
Email 4346 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual participant data 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.