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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
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
Secondary ID [1] 280910 0
Nil
Universal Trial Number (UTN)
U1111-1129-9878
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Personality Disorders 286752 0
Mental Health 286753 0
Condition category
Condition code
Mental Health 287051 287051 0 0
Psychosis and personality disorders
Mental Health 287052 287052 0 0
Other mental health disorders
Public Health 287322 287322 0 0
Health service research

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 285132 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 287388 0
Change in hospital use measured by audit of medical record admission and discharge data.
Timepoint [1] 287388 0
12 months
Secondary outcome [1] 298047 0
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).
Timepoint [1] 298047 0
12 months
Secondary outcome [2] 347774 0
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
Timepoint [2] 347774 0
12 months

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)
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation (computer sequence)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Delayed randomised controlled trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2011
Actual
22/06/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
401
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11085 0
Wollongong Hospital - Wollongong
Recruitment hospital [2] 11086 0
Shoalhaven Hospital - Nowra
Recruitment hospital [3] 11087 0
The Sutherland Hospital - Caringbah
Recruitment hospital [4] 11088 0
St George Hospital - Kogarah
Recruitment hospital [5] 11089 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [6] 11090 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [7] 11091 0
Bowral Hospital - Bowral
Recruitment hospital [8] 11092 0
Liverpool Hospital - Liverpool
Recruitment hospital [9] 11093 0
Fairfield Hospital - Prairiewood
Recruitment postcode(s) [1] 22897 0
2500 - Wollongong
Recruitment postcode(s) [2] 22898 0
2541 - Nowra
Recruitment postcode(s) [3] 22899 0
2229 - Caringbah
Recruitment postcode(s) [4] 22900 0
2217 - Kogarah
Recruitment postcode(s) [5] 22901 0
2031 - Randwick
Recruitment postcode(s) [6] 22902 0
2560 - Campbelltown
Recruitment postcode(s) [7] 22903 0
2576 - Bowral
Recruitment postcode(s) [8] 22904 0
2170 - Liverpool
Recruitment postcode(s) [9] 22905 0
2176 - Prairiewood

Funding & Sponsors
Funding source category [1] 285480 0
Government body
Name [1] 285480 0
NSW Health
Country [1] 285480 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Avenue, Wollongong NSW 2522
Country
Australia
Secondary sponsor category [1] 284332 0
None
Name [1] 284332 0
Address [1] 284332 0
Country [1] 284332 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287497 0
University of Wollongong and Health District Human Research Ethics Committee
Ethics committee address [1] 287497 0
Ethics committee country [1] 287497 0
Australia
Date submitted for ethics approval [1] 287497 0
Approval date [1] 287497 0
23/02/2011
Ethics approval number [1] 287497 0
HE10-371
Ethics committee name [2] 300598 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee
Ethics committee address [2] 300598 0
Ethics committee country [2] 300598 0
Australia
Date submitted for ethics approval [2] 300598 0
Approval date [2] 300598 0
13/09/2016
Ethics approval number [2] 300598 0
HE16-277

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

Contacts
Principal investigator
Name 34345 0
Prof Brin Grenyer
Address 34345 0
School of Psychology, University of Wollongong, NSW. Australia 2522
Country 34345 0
Australia
Phone 34345 0
+61 2 42213474
Fax 34345 0
Email 34345 0
grenyer@uow.edu.au
Contact person for public queries
Name 17592 0
Brin Grenyer
Address 17592 0
School of Psychology,
Northfields Avenue,
University of Wollongong NSW 2522
Country 17592 0
Australia
Phone 17592 0
+61 2 42213474
Fax 17592 0
+61 2 42213163
Email 17592 0
grenyer@uow.edu.au
Contact person for scientific queries
Name 8520 0
Brin Grenyer
Address 8520 0
School of Psychology,
Northfields Avenue,
University of Wollongong NSW 2522
Country 8520 0
Australia
Phone 8520 0
+61 2 42213474
Fax 8520 0
+61 2 42213163
Email 8520 0
grenyer@uow.edu.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseTreatment of personality disorder using a whole of service stepped care approach: A cluster randomized controlled trial.2018https://dx.doi.org/10.1371/journal.pone.0206472
N.B. These documents automatically identified may not have been verified by the study sponsor.