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Trial registered on ANZCTR
Registration number
ACTRN12618001674224
Ethics application status
Approved
Date submitted
8/10/2018
Date registered
10/10/2018
Date last updated
5/02/2021
Date data sharing statement initially provided
8/02/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Attention Control Training In Veterans to Augment Treatment (ACTIVATE)
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Scientific title
Attention training to augment post traumatic stress disorder treatment for veterans: A pilot RCT
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Secondary ID [1]
295907
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None
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Universal Trial Number (UTN)
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Trial acronym
ACTIVATE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Post traumatic stress disorder
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Condition category
Condition code
Mental Health
308424
308424
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Attention control training (ACT)
In ACT, participants perform four computer-delivered attention training sessions, taking 7 minutes per training session, over a period of 4 weeks (once weekly). Attention training sessions are delivered in the hospital. In each session the dot-probe task is administered. The task consists of 128 trials. Each trial begins with a centrally-presented fixation cross that is then replaced by a pair of neutral and threat words. A target probe appears in the location previously occupied by one of the words, and participants are requested to discriminate the probe type via button press. In ACT, targets appear with equal probability at the location of threat and neutral stimuli, in order to modify the fluctuations in attention allocation. Reaction time duration and incorrect responses are reviewed post-hoc to assess adherence to the intervention.
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Intervention code [1]
312393
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Treatment: Other
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Comparator / control treatment
Attention Bias Modification (ABM)
In ABM participants perform four computer-delivered attention training sessions, taking 7 minutes per training session, over a period of 4 weeks (once weekly). Attention training sessions are delivered in the hospital. In each session the dot-probe task is administered. The task consists of 128 trials. Each trial begins with a centrally-presented fixation cross that is then replaced by a pair of neutral and threat words. A target probe appears in the location previously occupied by the neutral word, and participants are requested to discriminate the probe type via button press. In ABM, the probe always appears in the location opposite to the threat word (i.e., replaces the location of the neutral word). Reaction time duration and incorrect responses are reviewed post-hoc to assess adherence to the intervention.
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Control group
Active
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Outcomes
Primary outcome [1]
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Severity of PTSD symptoms as measured by the PTSD Checklist (PCL-5). The PCL-5 is a 20-item self-report scale with scores ranging from 0 to 80, with higher scores reflecting more symptoms of PTSD (Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013).
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Assessment method [1]
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Timepoint [1]
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Pre-attention training, post-attention training, post-treatment as usual (primary timepoint), 3 months follow-up, 9 months follow-up.
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Secondary outcome [1]
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Symptoms of anxiety and depression will be measured using the The Hospital Depression Anxiety Scale (HADS; Zigmond & Snaith, 1983) with a total of 7 items for each subscale. Participants are asked to respond to 14 items on a 4-point Likert scale ranging from 0 to 3.
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Assessment method [1]
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Timepoint [1]
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Pre-attention training, post-attention training, post-treatment as usual, 3 months follow-up, 9 months follow-up.
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Secondary outcome [2]
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Psychological distress will be measued using the Kessler Psychological Distress Scale. This was developed by Kessler and others in 1992 as a screening instrument for mental health conditions and as a measure of non-specific psychological distress (Kessler et al, 2002).
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Assessment method [2]
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Timepoint [2]
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Pre-attention training, post-attention training, post-treatment as usual, 3 months follow-up, 9 months follow-up.
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Secondary outcome [3]
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Anger severity will be measured using the Dimensions of Anger Reactions (Forbes, Alkemade, Mitchell, et al., 2014). It comprised of 5 items relating to anger reactions and is a concise measure of anger severity. It has demonstrated strong psychometric properties in a combat veteran population (Forbes, Alkemade, Hopcraft, et al., 2014).
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Assessment method [3]
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Timepoint [3]
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Pre-attention training, post-attention training, post-treatment as usual, 3 months follow-up, 9 months follow-up.
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Secondary outcome [4]
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Pain will be measured using the Visual Analog Scale for Pain (Hawker, Mian, Kendzerska, & French, 2011), a unidimensional measure of pain intensity. It has been widely used in a diverse range of adult populations.
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Assessment method [4]
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Timepoint [4]
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Pre-attention training, post-attention training, post-treatment as usual, 3 months follow-up, 9 months follow-up.
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Secondary outcome [5]
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Attention Bias Variability (ABV) is a measure of the degree to which attention fluctuates between vigilance and avoidance. It is calculated using reaction time data from the dot-probe computer-based task. In this task, pairs of anger and neutral faces are simultaneously presented on the computer screen. Each stimulus pair is followed by a target probe appearing randomly at the location of either the angry face or the neutral face. Participants press a key indicating which probe appeared. The task consists of 64 items. Response latencies on the task provide a “snap-shot” of the distribution of the subject’s attention, with faster responses to probes presented in the attended relative to the unattended location. For example, attention bias toward threat is evident when participants are faster to respond to probes that replace threat stimuli rather than neutral stimuli. The reverse pattern indicates threat-related attentional avoidance.
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Assessment method [5]
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Timepoint [5]
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Pre-attention training, post-attention training and post-treatment as usual.
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Secondary outcome [6]
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Capacity for attention training to prepare an individual for standard treatment will be measured using the Readiness for Psychotherapy Index (Ogrodniczuk, Joyce, & Piper, 2009), which is a 20-item scale that assesses four aspects of readiness. An additional item measuring readiness to engage with the trauma memory was also added.
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Assessment method [6]
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Timepoint [6]
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Pre and post attention training.
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Eligibility
Key inclusion criteria
An ex-serving member of the Australian Defence Force
Have a diagnosis of PTSD, confirmed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Eligible for participation and consented to participate in the Toowong Hospital Trauma Recovery Program (TRP)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
A currently serving member of ADF
Unable to use a computer keyboard
Unable or ineligible to participate in the Toowong TRP
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be used for this trial. Specifically, a central randomisation website will be utilised that assigns a participant to either condition 1 or 2. Neither participants nor the administering research assistant will know which is ABM and which is ACT.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using a randomisation table created by computer software (i.e. computerised sequence generation),
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
As this is a pilot RCT testing feasibility of the intervention in this population and in an augmentative capacity to standard treatment, no formal power analyses has been conducted. Our recruitment target of 50 participants (25 participants in each group) are similar to those used in previous studies that detected significant differences between the active and control groups.
Descriptive statistics will be used to summarise characteristics of intervention and control conditions, with regards to baseline characteristics and patterns of change over time. Differences between intervention and control conditions, on both primary and secondary outcomes, will be evaluated in a regression-based framework and in accordance with intention-to-treat (ITT) principles. Historical data previously collected in a sample of veterans with PTSD who received the Toowong TRP (i.e., this study's TAU) will be used to create a matched sample to further investigate change in PTSD scores between the intervention, control, and the historical sample.
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data analysis is complete
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Reason for early stopping/withdrawal
Other reasons/comments
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Other reasons
COVID-19
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Date of first participant enrolment
Anticipated
22/10/2018
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Actual
1/11/2018
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Date of last participant enrolment
Anticipated
30/10/2020
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Actual
17/02/2020
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Date of last data collection
Anticipated
30/07/2021
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Actual
27/03/2020
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Sample size
Target
50
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Accrual to date
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Final
17
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Toowong Private Hospital - Toowong
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Recruitment postcode(s) [1]
23975
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4066 - Toowong
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Centenary of Anzac Centre, Phoenix Australia - Centre for Posttraumatic Mental Health
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Address [1]
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Department of Psychiatry, The University of Melbourne
Level 3, Alan Gilbert Building,
161 Barry Street
Carlton VIC 3053
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Country [1]
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
Centenary of Anzac Centre, Phoenix Australia
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Address
Department of Psychiatry, The University of Melbourne
Level 3, Alan Gilbert Building,
161 Barry Street
Carlton VIC 3053
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
300459
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Other collaborator category [1]
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Hospital
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Name [1]
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Toowong Private Hospital
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Address [1]
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496 Milton Rd, Toowong QLD 4066
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Country [1]
280357
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Australia
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Other collaborator category [2]
280358
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University
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Name [2]
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Tel Aviv University
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Address [2]
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Laboratory for Research on Anxiety and Trauma
School of Psychological Sciences
Tel Aviv University
Tel Aviv, Israel 69978
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Country [2]
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Israel
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Department of Veterans’ Affairs Human Research Ethics Committee, the Departments of Defence and Veterans’ Affairs (DDVA HREC)
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Ethics committee address [1]
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DDVA HREC Secretariat CP3-6-037 Department of Defence Canberra ACT 2600
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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26/07/2018
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Approval date [1]
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05/09/2018
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Ethics approval number [1]
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050-18
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Summary
Brief summary
PTSD is the most common psychological disorder in veterans, and while evidence-based treatments exist, much can be done to improve outcomes. The study is a pilot randomised-controlled-trial comparing two interventions in veterans with a diagnosis of PTSD before and after they receive standard hospital treatment. This study will test the efficacy of two types of attention training to augment standard treatment for veterans with a diagnosis of PTSD. Attention training is delivered via computer and involves participants viewing words on a screen and then pressing a corresponding button on the keyboard. The first task, ‘Attention Control Training’ (ACT) works by re-balancing attention, whilst 'Attention Bias Modification; (ABM) aims to decrease over-responding to threat stimuli. We want to investigate whether receiving either one of these attention training programs significantly improves mental health outcomes after receiving standard treatment.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Meaghan O'Donnell
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Address
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Phoenix Australia, Level 3, Alan Gilbert Building, 161 Barry Street Carlton VIC 3053
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Country
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Australia
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Phone
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+61 3 9035 5599
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Olivia Metcalf
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Address
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Phoenix Australia, Level 3, Alan Gilbert Building, 161 Barry Street Carlton VIC 3053
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Country
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Australia
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Phone
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+61 3 9035 5599
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Olivia Metcalf
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Address
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Phoenix Australia, Level 3, Alan Gilbert Building, 161 Barry Street Carlton VIC 3053
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Country
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Australia
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Phone
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+61 3 9035 5599
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Fax
86536
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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