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Trial registered on ANZCTR
Registration number
ACTRN12623001203640p
Ethics application status
Submitted, not yet approved
Date submitted
18/10/2023
Date registered
22/11/2023
Date last updated
22/11/2023
Date data sharing statement initially provided
22/11/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
A randomized controlled trial of Cognitive Processing Therapy for 18-35-year-olds with co-occurring post-traumatic stress and substance use disorders.
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Scientific title
A randomized controlled trial of Cognitive Processing Therapy for 18-35-year-olds with co-occurring post-traumatic stress and substance use disorders in residential substance use treatment.
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Secondary ID [1]
310542
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
This study is a follow-up from the studies registered as: ACTRN12621000296831 and ACTRN12621000492853.
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Health condition
Health condition(s) or problem(s) studied:
post-traumatic stress disorder
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substance use disorders
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other mental health disorders
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Condition category
Condition code
Mental Health
328112
328112
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0
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Addiction
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Mental Health
328113
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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
Cognitive processing therapy (CPT) is a 'gold-standard' cognitive behavioral therapy that has been effective in reducing symptoms of PTSD that have developed after experiencing a variety of traumatic events including child abuse, combat, rape and natural disasters (Resick et al., 2016). CPT is a 12-session protocol that will be delivered by a team of trained clinicians (primarily case managers supervised by a board-approved, endorsed clinical psychologist) on an individual, twice-weekly basis, over 6 weeks, with 60-minute sessions. Sessions are delivered through telehealth (video-based) format.
Session 1 -
The goals for the first session of CPT are to engage the client in treatment and provide psychoeducation on the relationship between PTSD and substance use. The therapist also explains the rationale behind CPT: giving client’s tools to examine their thoughts and emotions, feeling the natural emotions arising from the trauma, and changing thoughts around trauma that are keeping client’s stuck (referred to as stuck points in CPT).
Sessions 1-3 -
Sessions 1-3 will focus on preparing the client for CPT and identifying stuck points that have interfered with the client’s recovery after their trauma(s), including the role of substance use. These sessions are foundational to developing the client’s association between thoughts and feelings and the client is taught to identify and self-monitor these associations.
Sessions 4- 5 -
The goal for these sessions are for the client to be able to label events, thoughts, and emotions and to understand the connections among them. These sessions will also introduce categorising thoughts objectively as well as challenging the client’s individual thoughts that can be related to the trauma or substance use behaviour.
Sessions 6-8 -
The first goal of these sessions are to teach the clients to become their own cognitive therapists based on the techniques learned thus far in therapy. Secondly, the clients are asked to identify their patterns of problematic thinking in relation to the traumatic event(s) and substance use. These sessions also begin to challenge core beliefs related to the traumatic event.
Sessions 9-12 -
The primary goals of the remainder of the sessions is to continue challenging the clients trauma related beliefs as well as examine the themes of Safety, Trust, Esteem, Intimacy and Power and Control related to the traumatic event. In addition, the client and therapist continue to integrate any unresolved ‘stuck points’ relevant to the index trauma. A modification which will be made at the end of treatment from the original protocol will be to add relapse prevention into the clients final sessions.
Treatment fidelity of the intervention will be monitored through: a) de-identified audio recordings which will be assessed at the end of treatment by independent CPT clinicians, b) session checklists for clinicians during sessions, and c) weekly supervision of clinicians by a trained, board-approved clinical supervisor specializing in the delivery of CPT.
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Intervention code [1]
327137
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Rehabilitation
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Intervention code [2]
327322
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Behaviour
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Comparator / control treatment
The comparator condition will include a treatment-as-usual condition. Participants who are randomised to this condition will receive regular residential treatment offered as part of the standard service program and participate in the same outcome assessment as the intervention condition. Participants will be told their allocated condition in the first week of treatment by their case manager in the facility.
The standard service program is a residential, live-in service that includes a 6-week group program focused on substance use recovery, individual case management and counselling, and medical and psychiatric assistance.
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Control group
Active
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Outcomes
Primary outcome [1]
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PTSD symptoms on the PTSD Checklist for DSM-5 (PCL-5)
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Assessment method [1]
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Timepoint [1]
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baseline, weekly and 1, 3, 6, and 12-months (primary timepoint) post-baseline
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Primary outcome [2]
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Substance Use measured on The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) questionnaire
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Assessment method [2]
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Timepoint [2]
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baseline and 1, 3, 6, and 12-months post-baseline
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Primary outcome [3]
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Substance use measured using the Australian Treatment Outcomes Profile and Quality of Life (ATOP) questionnaire
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Assessment method [3]
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Timepoint [3]
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baseline and 1, 3, 6, and 12-months post-baseline
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Secondary outcome [1]
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Depression measured on the Patient Health Questionnaire (PHQ-9)
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Assessment method [1]
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Timepoint [1]
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baseline and 1, 3, 6, and 12-months post-baseline
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Secondary outcome [2]
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Anxiety measured on the Generalised Anxiety Disorder Scale (GADS-7).
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Assessment method [2]
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Timepoint [2]
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baseline and 1, 3, 6, and 12-months post-baseline
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Secondary outcome [3]
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Post-traumatic cognition as measured by the Posttraumatic Cognitions Inventory (PTCI)
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Assessment method [3]
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Timepoint [3]
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baseline and 1, 3, 6, and 12-months post-baseline
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Eligibility
Key inclusion criteria
1) Positive PTSD screen on the PCL-5 (+31). The PCL-5 is a measure used to assess PTSD symptomatology based on the DSM-5 criteria. This requires the client to need at least: 1 B item (questions 1-5), 1 C item (questions 6-7), 2 D items (questions 8-14), 2 E items (questions 15-20) on the PCL-5.
2) Attendance at one of the participating Lives Lived Well residential facilities
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Minimum age
18
Years
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Maximum age
35
Years
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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
Following CPT protocol recommendations (Resick et al., 2016), participants will be excluded from therapy if they meet any of the following:
a) non-fluent in English
b) acutely suicidal
c) current diagnosis of schizophrenia, currently manic bipolar, or intellectual disability
d) Experienced a trauma that had occurred before the age of three (as there is an inability to remember the trauma)
e) the participant's cognitive capacity is limited such that they are unable to understand the therapeutic concepts and worksheets offered.
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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 is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation using simple randomisation coin-tossing
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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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
For client sample size, a power calculation for the trial including two groups will require a total sample size of 128 participants for adequate power (.8) to detect a medium effect (f =.25, equivalent to a Cohen’s d medium effect size of 0.5) over two time points (calculated using G*Power 3.1). Using a medium effect and only two time points for the calculation was a conservative approach to calculate the sample size to maximise the likelihood to detect an effect, even though there will be more time points. A similar recent study that was run at the Lives Lived Well Mirikai facility recruited 118 clients over an 8-month period. Since the current project will be recruiting clients over a 12-month period, we envisage recruiting at least 177 clients over this time period.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/02/2024
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Actual
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Date of last participant enrolment
Anticipated
1/07/2025
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Actual
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Date of last data collection
Anticipated
1/07/2026
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Actual
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Sample size
Target
177
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council (NHMRC)
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Address [1]
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GPO Box 1421 Canberra ACT 2601
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Country [1]
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Australia
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Primary sponsor type
University
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Name
The University of Queensland
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Address
School of Psychology McElwain Building The University of Queensland St Lucia QLD 4072
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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]
316724
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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The University of Queensland Human Research Ethics Committee
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Ethics committee address [1]
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Level 3, Brian Wilson Chancellery The University of Queensland St Lucia QLD 4072
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
313754
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09/10/2023
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Approval date [1]
313754
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Ethics approval number [1]
313754
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Summary
Brief summary
There are disproportionately higher rates of lifetime trauma and Post-traumatic Stress Disorder (PTSD) among people with substance use disorders (SUDs), which can both precede, and occur as a consequence of substance use. Cognitive Processing Therapy (CPT) is a ‘gold-standard’ PTSD treatment, with a strong emphasis on processing and restructuring maladaptive beliefs around a traumatic event without employing exposure-based strategies. However, the effectiveness of CPT for individuals with co-occurring PTSD and SUD has not been extensively studied. The current project will be a randomized controlled parallel-group trial, which will determine the outcomes of CPT for young people with SUD/PTSD in the residential treatment setting for substance use. Participants will be randomised to receive either TAU or CPT alongside their usual residential treatment (CPT+TAU). Client outcomes on measures of substance use and PTSD, depression, anxiety symptoms will be evaluated at baseline, 1-, 3-, 6-, and 12-months follow-up.
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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 Leanne Hides
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Address
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School of Psychology McElwain Building The University of Queensland St Lucia QLD 4072
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Country
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Australia
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Phone
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+61 7 336 56398
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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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Miss Valeriya Mefodeva
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Address
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School of Psychology McElwain Building The University of Queensland St Lucia QLD 4072
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Country
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Australia
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Phone
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+61 7 336 56398
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Fax
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Email
129251
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[email protected]
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Contact person for scientific queries
Name
129252
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Miss Valeriya Mefodeva
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Address
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School of Psychology McElwain Building The University of Queensland St Lucia QLD 4072
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Country
129252
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Australia
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Phone
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+61 7 336 56398
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Fax
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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)?
Yes
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What data in particular will be shared?
All of the de-identified baseline and follow up data collected
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When will data be available (start and end dates)?
Within 12 months of the conclusion of the study
No end date specified
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Available to whom?
Only researchers who provide a methodologically sound proposal will be provided with access to the data on a case-by-case basis
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Available for what types of analyses?
Only to achieve the aims in the approved proposal
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How or where can data be obtained?
via University of Queensland Research Data Management System website
https://rdm.uq.edu.au/
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
20679
Study protocol
[email protected]
20680
Statistical analysis plan
[email protected]
20681
Ethical approval
[email protected]
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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