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Trial registered on ANZCTR
Registration number
ACTRN12624001261505
Ethics application status
Approved
Date submitted
24/03/2024
Date registered
16/10/2024
Date last updated
16/10/2024
Date data sharing statement initially provided
16/10/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
The Stay Strong App, Use of a Digital Wellbeing App with Indigenous People in Prison: A Randomized Controlled Trial
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Scientific title
Efficacy of the Stay Strong App, a Digital Wellbeing App targeting Wellbeing, Empowerment and Psychological Distress in Indigenous People in Prison: A Randomized Controlled Trial
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Secondary ID [1]
311669
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
psychological distress
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empowerment
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wellbeing
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Condition category
Condition code
Mental Health
329826
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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
The Stay Strong App (SSA) is a culturally safe intervention tool, developed to enhance the wellbeing and mental health of Aboriginal and Torres Strait Islander peoples. It is an Android app delivered in conjunction with a therapist on tablet pcs, with administration of the SSA taking approximately 60 minutes. Therapeutic adherence is supported through practitioner supervision and training.
The SSA is an 11-step intervention involving (1) the collection of demographics, (2) “people who keep me strong” or the identification of support people and the nature of their relationship, (3) strengths or factors that support client well-being, (4) worries or factors that reduce client well-being , (5) setting the client’s first goal for change, (6) setting the client’s second goal for change, (7) well-being tips, (8) tips to reduce substance use, (9) “my support” or a description of professional supports and contact details for use upon release from prison, (10) “client summary” or a review of client information provided across the previous 9 steps, and (11) the provision of a client card to the client.
Items relating to the Stay Strong Tree (steps 3 and 4) provide descriptive data on the strengths and worries that were identified in the SSA sessions. The tree is divided into a 4-root system, representative of the four aspects of a client’s life: (1) spiritual and cultural; (2) physical; (3) family, social, and emotional; and (4) mental and emotional aspects. Each root system is then divided into individual strength or worry items (strengths: 16, including 4 open items idiosyncratic to clients; worries: 16 items, including 2 open items idiosyncratic to clients; steps 3 and 4). These items in the SSA represent the key determinants of SEWB for Aboriginal and Torres Strait Islander people.
The primary aim of the project was to conduct a randomized controlled trial (RCT) within Queensland prisons to determine the feasibility and effectiveness of the SSA with Indigenous female and male prisoners. The project was conducted through the Indigenous Mental Health Intervention Program (IMHIP), a social and emotional wellbeing (SEWB) and mental health service for Aboriginal and Torres Strait Islander people in custody. The SSA was added to existing IMHIP services immediately after a baseline assessment or after a 3-month delay, and wellbeing, empowerment and psychological distress were assessed at Baseline, 3 and 6 months. Delivery of the SSA was facilitated in-person by Indigenous practitioners, requiring no prior computer literature of clients. Indigenous participants were recruited from three high-security Australian prisons from January 2017 to September 2019. The outcome measures assessed wellbeing (Warwick-Edinburgh Mental Wellbeing Scale, WWS), empowerment (Growth and Empowerment Measure, GEM, giving Total, EE14 and 12S scores) and psychological distress (Kessler Psychological Distress Scale, K10). Intention-to-treat effects on these outcomes were analysed using Linear Mixed Models.
Clients were provided with 2 copies of their client cards, one for use while in prison and one for their prison property, which would become available to them upon release from prison. Each client card had a summary of the SSA, including professional supports and contact details. The laminated cards were folded in a way that allowed clients to display their support network, or “people who help me are,” in their prison cells.
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Intervention code [1]
328133
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Prevention
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Intervention code [2]
329492
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Behaviour
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Comparator / control treatment
The trial compared Immediate and three month Delayed use of the intervention.
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Control group
Active
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Outcomes
Primary outcome [1]
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Wellbeing
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Assessment method [1]
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Warwick-Edinburgh Mental Wellbeing Scale
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Timepoint [1]
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Baseline, 3months and 6 months post-baseline
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Primary outcome [2]
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Empowerment
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Assessment method [2]
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Growth and Empowerment Measure
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Timepoint [2]
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Baseline, 3 months and 6 months post-baseline
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Primary outcome [3]
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Psychological Distress
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Assessment method [3]
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Kessler Psychological Distress Scale
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Timepoint [3]
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Baseline, 3 months and 6 months post-baseline
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Secondary outcome [1]
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Change in number of strengths identified within app
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Assessment method [1]
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For the secondary analyses examining whether the number of strengths and worries changed from the first SSA session (ie, at baseline for the immediate group and 3 months for the delayed group) to the session 3 months later (ie, at 3 months for the immediate group and 6 months for the delayed group). As a result, there were only 2 time points and a single time effect for those analyses.
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Timepoint [1]
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Comparison between baseline, 3 months post-baseline and 6 months post-baseline
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Secondary outcome [2]
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Change in number of worries identified within app
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Assessment method [2]
439668
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For the secondary analyses examining whether the number of strengths and worries changed from the first SSA session (ie, at baseline for the immediate group and 3 months for the delayed group) to the session 3 months later (ie, at 3 months for the immediate group and 6 months for the delayed group). As a result, there were only 2 time points and a single time effect for those analyses.
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Timepoint [2]
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Comparison between baseline, 3 months post-baseline and 6 months post-baseline
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Eligibility
Key inclusion criteria
All Aboriginal and Torres Strait Islander peoples in custody who were engaged with Indigenous Mental Health Intervention Program (IMHIP), who had the capacity to consent were invited by IMHIP staff to participate in the study. This invitation involved both a written and verbal explanation of the study and consent forms.
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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?
Yes
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Key exclusion criteria
Participants who caused safety concerns for staff
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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)
central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation created by computer
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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
Other
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Other design features
Outcome measures were administered by IMHIP practitioners to all available participants at baseline, 3 months, and 6 months at the beginning of treatment sessions. The immediate intervention group had SSA sessions after each assessment, while the delayed group had sessions only at 3 and 6 months.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Intention-to-treat effects on these outcomes were analysed using Linear Mixed Models.
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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
Study complete with retrospective trial registration for publication
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Date of first participant enrolment
Anticipated
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Actual
9/01/2017
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Date of last participant enrolment
Anticipated
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Actual
30/09/2019
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Date of last data collection
Anticipated
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Actual
31/03/2020
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Sample size
Target
200
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Accrual to date
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Final
132
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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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Queensland Health
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Address [1]
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Country [1]
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Australia
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Funding source category [2]
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Government body
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Name [2]
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Queensland Corrective Services
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Address [2]
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Country [2]
317393
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Australia
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Funding source category [3]
317394
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University
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Name [3]
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University of Queensland
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Address [3]
317394
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Country [3]
317394
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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
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Country
Australia
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Secondary sponsor category [1]
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Government body
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Name [1]
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Queensland Health
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Address [1]
318145
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Country [1]
318145
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Darling Downs Hospital and Health Service Human Research Ethics Committee
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Ethics committee address [1]
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https://www.health.qld.gov.au/darlingdowns/html/ddhhs-hrec.asp
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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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06/08/2014
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Approval date [1]
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04/03/2015
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Ethics approval number [1]
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HREC/14/QTDD/65
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Ethics committee name [2]
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The University of Queensland Human Research Ethics Committee A
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Ethics committee address [2]
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https://www.uq.edu.au/research/research-support/ethics-integrity-and-compliance/human-ethics
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
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06/08/2014
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Approval date [2]
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10/03/2015
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Ethics approval number [2]
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2015000360
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Summary
Brief summary
This study aimed to conduct a pilot trial evaluating the impact of adding the Stay Strong app (SSA) to mental health and wellbeing services for Indigenous women and men in custody. The trial compared Immediate and three month Delayed use of the app by the health service, assessing its effects on wellbeing, empowerment and psychological distress at three and six months post-Baseline.
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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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Dr Elke Perdacher
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Address
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Queensland Forensic Mental Health Service, GPO Box 8161, Brisbane Qld 4001
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Country
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Australia
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Phone
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+617 3837 5820
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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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Elke Perdacher
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Address
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Queensland Forensic Mental Health Service, GPO Box 8161, Brisbane Qld 4001
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Country
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Australia
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Phone
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+617 3837 5820
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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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Elke Perdacher
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Address
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Queensland Forensic Mental Health Service, GPO Box 8161, Brisbane Qld 4001
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Country
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Australia
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Phone
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+617 3837 5820
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Fax
132832
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Email
132832
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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
Data not approved to be made available publicly
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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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