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Trial registered on ANZCTR
Registration number
ACTRN12612000843853
Ethics application status
Approved
Date submitted
3/07/2012
Date registered
13/08/2012
Date last updated
6/06/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Treatment of personality disorders using a whole of service guidelines-based approach
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Scientific title
Treatment of personality disorders using a whole of service guidelines-based approach to improve functioning and reduce hospital use: a delayed randomised controlled trial
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Secondary ID [1]
280910
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Nil
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Universal Trial Number (UTN)
U1111-1129-9878
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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:
Personality Disorders
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Mental Health
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Condition category
Condition code
Mental Health
287051
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0
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Psychosis and personality disorders
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Mental Health
287052
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0
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Other mental health disorders
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Public Health
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Active intervention is a whole of service guidelines-based treatment, derived from a relationship model, and will be compared to treatment as usual (TAU). The approach emphasises good clinical care grounded in developed treatment guidelines (Project Air Strategy for Personality Disorders 2011) derived from the NICE (2009) and Gunderson and Links Clinical Guide for treating people with Personality Disorders (2008). Treatment is a stepped care approach, including specialised individual, group and family interventions delivered by mental health professionals trained in the model, for up to 12 months. Service sections are randomly divided into practice sites receiving the intervention or treatment as usual. After a 12-month delay, planning and implementation for the TAU site will commence.
The study has two aims: (1) to assess the impact of the implementation compared to TAU on a service level, using hospital records (primary outcome), and (2) to assess the impact of the implementation on patient outcomes and therapist knowledge and attitudes (secondary outcomes).
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Intervention code [1]
285132
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Treatment: Other
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Comparator / control treatment
Treatment as usual standard care. Standard care involves medical care and case management by health care professionals for up to 12 months and will vary on a case-by-case basis.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in hospital use measured by audit of medical record admission and discharge data.
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Assessment method [1]
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Timepoint [1]
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12 months
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Secondary outcome [1]
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Change in likert scale ratings of therapist confidence and skills in treating personality disorders measured by questionnaire, following implementation of the model. The questionnaire was specifically designed, and included the Attitudes towards Personality Disorder Questionnaire (APDQ; Bowers & Allan, 2006), the Attitudes towards Deliberate Self-harm Questionnaire (ADSHQ; McAllister, Creedy, Moyle & Farrugia, 2002), and the Attitudes and Skills Questionnaire (ASQ; Krawitz, 2004).
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Assessment method [1]
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Timepoint [1]
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12 months
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Secondary outcome [2]
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Change in patient clinical functioning as measured by clinical assessment of diagnostic borderline personality disorder criteria symptoms (number and severity of DSM-IV borderline personality disorder diagnostic criteria), following implementation of the model
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Assessment method [2]
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Timepoint [2]
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12 months
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Eligibility
Key inclusion criteria
Meets diagnostic criteria for Personality Disorder
Ability and willingness to give informed consent and comply with study procedures (secondary outcome)
Aged 12 or older
Seeking treatment at a service within the indicated geographical location
Fluent in English (secondary outcome)
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Minimum age
12
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
Psychiatric condition due to a medical condition
Primary diagnosis of Schizophrenia or Drug and Alcohol Dependence
Are unlikely to be able to read and understand the information sheet and consent form
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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)
Participants will be recruited from the NSW Health Illawarra-Shoalhaven and South Eastern Sydney Local Health Districts. All patients who meet the inclusion criteria will be eligible to participate in this study. Written and informed consent will be obtained from all participants. Service sections randomly divided into practice sites recieving intervention or treatment as usual. Participants were unaware (blind) to allocation status. Allocation was done off site by randomisation generator.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation (computer sequence)
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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
Delayed randomised controlled trial
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/04/2011
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Actual
22/06/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
1000
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Accrual to date
401
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Wollongong Hospital - Wollongong
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Recruitment hospital [2]
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Shoalhaven Hospital - Nowra
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Recruitment hospital [3]
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The Sutherland Hospital - Caringbah
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Recruitment hospital [4]
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St George Hospital - Kogarah
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Recruitment hospital [5]
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Prince of Wales Private Hospital - Randwick
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Recruitment hospital [6]
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Campbelltown Hospital - Campbelltown
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Recruitment hospital [7]
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Bowral Hospital - Bowral
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Recruitment hospital [8]
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Liverpool Hospital - Liverpool
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Recruitment hospital [9]
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Fairfield Hospital - Prairiewood
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Recruitment postcode(s) [1]
22897
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2500 - Wollongong
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Recruitment postcode(s) [2]
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2541 - Nowra
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Recruitment postcode(s) [3]
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2229 - Caringbah
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Recruitment postcode(s) [4]
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2217 - Kogarah
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Recruitment postcode(s) [5]
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2031 - Randwick
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Recruitment postcode(s) [6]
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2560 - Campbelltown
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Recruitment postcode(s) [7]
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2576 - Bowral
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Recruitment postcode(s) [8]
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2170 - Liverpool
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Recruitment postcode(s) [9]
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2176 - Prairiewood
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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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NSW Health
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Address [1]
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Locked Mail Bag 961, North Sydney NSW 2059
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Wollongong
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Address
Northfields Avenue, Wollongong NSW 2522
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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]
284332
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Country [1]
284332
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of Wollongong and Health District Human Research Ethics Committee
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Ethics committee address [1]
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Research Services Office, Northfields Avenue, University of Wollongong, NSW 2522
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
287497
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Approval date [1]
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23/02/2011
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Ethics approval number [1]
287497
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HE10-371
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Ethics committee name [2]
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Joint University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee
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Ethics committee address [2]
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Research Services Office, Northfields Avenue, University of Wollongong, NSW 2522
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
300598
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Approval date [2]
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13/09/2016
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Ethics approval number [2]
300598
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HE16-277
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Summary
Brief summary
Treatment for personality disorder is effective but only specialist long-term approaches have been studied on specific subsets of patients with highly trained staff. This study aims to evaluate a whole of service approach in a large public mental health service. The treatment is guidelines-based approach based on a relationship model (Project Air Strategy for Personality Disorders 2011). A delayed randomised controlled trial compares this approach to standard care.
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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 Brin Grenyer
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Address
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School of Psychology, University of Wollongong, NSW. Australia 2522
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Country
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Australia
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Phone
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+61 2 42213474
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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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Prof Brin Grenyer
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Address
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School of Psychology,
Northfields Avenue,
University of Wollongong NSW 2522
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Country
17592
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Australia
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Phone
17592
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+61 2 42213474
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Fax
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+61 2 42213163
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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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Prof Brin Grenyer
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Address
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School of Psychology,
Northfields Avenue,
University of Wollongong NSW 2522
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Country
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Australia
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Phone
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+61 2 42213474
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Fax
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+61 2 42213163
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Current supporting documents:
Updated to:
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
23228
Study protocol
-999999
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Treatment of personality disorder using a whole of service stepped care approach: A cluster randomized controlled trial.
2018
https://dx.doi.org/10.1371/journal.pone.0206472
N.B. These documents automatically identified may not have been verified by the study sponsor.
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