Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000844842
Ethics application status
Approved
Date submitted
25/07/2012
Date registered
13/08/2012
Date last updated
13/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised control trial of the efficacy of a psychoeducational support group for carers of persons with personality disorder
Scientific title
In carers of persons with personality disorders, does a psychoeducational support group, compared to waitlist control, benefit the caregiving relationship?
Secondary ID [1] 280775 0
nil
Universal Trial Number (UTN)
U1111-1132-3914
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wellbeing of carers of persons with personality disorders 286834 0
Burden experienced by carers of persons with personality disorder 286835 0
Condition category
Condition code
Mental Health 287144 287144 0 0
Psychosis and personality disorders
Public Health 287323 287323 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention for families, partners and carers is based on a relational model grounded in developed treatment guidelines (Project Air Strategy for Personality Disorders 2011). The group intervention includes a brief intervention workshop focusing on psychoeducation regarding personality disorders and awareness of relationship dynamics. The workshop is followed by group sessions (total of 8 hours) focussing on practical skills training in managing challenging relationship dynamics and enhancing support options. The duration of the workshop is 6 hours over one day, designed for about 25 carers per workshop. The group intervention is a 1 x 2 hour session per fortnight for 8 weeks. Groups are designed to commence a month after the workshop. The groups are designed for about 8 members each. The workshops and groups are facilitated by specialist family and carer clinicians.
Intervention code [1] 285201 0
Other interventions
Comparator / control treatment
Waitlist Control - brief intervention workshop focusing on psychoeducation regarding personality disorders and awareness of relationship dynamics followed by a waitlist control period prior to being offered the group intervention. The waitlist control group will be offered the group intervention approximately 4 months after the workshop.
Control group
Active

Outcomes
Primary outcome [1] 287457 0
Improved carer relationship adjustment as measured by the Burden Assessment Scale
Timepoint [1] 287457 0
Pre-workshop (Baseline), pre-group commencement, post completion of all group sessions, 12 month follow-up.
Secondary outcome [1] 298189 0
Improved carer mental health as measured by the Mental Health Inventory - 5 (MHI-5) within the SF-36
Timepoint [1] 298189 0
Pre-workshop (Baseline), pre-group commencement, post completion of all group sessions, 12 month follow-up.

Eligibility
Key inclusion criteria
The person with personality disorder (whom the participant is supporting) to be over 14 years of age,
To be a family member or significant other (including friend) of the person with personality disorder (not a paid professional carer),
The person whom the participant is supporting does not have Schizophrenia,
The person whom the participant is supporting does not have the primary problem of drug addiction,
The person whom the participant is supporting displays problems including personality disorder, problems with managing strong emotions, self-destructive or self-harming behaviour, and problems with identity and sense of self,
The participant is over 18 years of age (or accompanied by a parent/guardian if 16-17 years old),
The participant does not have significant mental health, physical or drug and alcohol concerns that might get in the way of their involvement or threaten the safety of other participants,
The participant agrees to commit to the group sessions or waitlist.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The person with personality disorder (whom the participant is supporting) is under 14 years of age,
The participant is a paid professional carer,
The person whom the participant is supporting has Schizophrenia,
The person whom the participant is supporting has the primary problem of drug addiction,
The participant is under 18 years of age (or not able to be accompanied by a parent/guardian if 16-17 years old),
The participant has significant mental health, physical or drug and alcohol concerns that may get in the way of their involvement or threaten the safety of other participants,
The participant cannot commit to the group sessions or the waitlist control.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Balanced and blocked randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Wait-list controlled trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5491 0
2541
Recruitment postcode(s) [2] 5492 0
2500
Recruitment postcode(s) [3] 5493 0
1499
Recruitment postcode(s) [4] 5494 0
1485
Recruitment postcode(s) [5] 5495 0
2031

Funding & Sponsors
Funding source category [1] 285561 0
Government body
Name [1] 285561 0
NSW Health
Country [1] 285561 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Avenue, Wollongong NSW 2522
Country
Australia
Secondary sponsor category [1] 284399 0
None
Name [1] 284399 0
Address [1] 284399 0
Country [1] 284399 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287577 0
University of Wollongong and SESIAHS Human Research Ethics Committee
Ethics committee address [1] 287577 0
Ethics committee country [1] 287577 0
Australia
Date submitted for ethics approval [1] 287577 0
Approval date [1] 287577 0
23/02/2011
Ethics approval number [1] 287577 0
HE10-371

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

Contacts
Principal investigator
Name 34391 0
Address 34391 0
Country 34391 0
Phone 34391 0
Fax 34391 0
Email 34391 0
Contact person for public queries
Name 17638 0
Brin Grenyer
Address 17638 0
School of Psychology, University of Wollongong
Northfields Avenue, Wollongong NSW 2522
Country 17638 0
Australia
Phone 17638 0
+61 2 42213474
Fax 17638 0
+61 2 42213163
Email 17638 0
[email protected]
Contact person for scientific queries
Name 8566 0
Brin Grenyer
Address 8566 0
School of Psychology, University of Wollongong
Northfields Avenue, Wollongong NSW 2522
Country 8566 0
Australia
Phone 8566 0
+61 2 42213474
Fax 8566 0
+61 2 42213163
Email 8566 0
[email protected]

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
EmbaseA Randomized Controlled Trial of Group Psychoeducation for Carers of Persons With Borderline Personality Disorder.2019https://dx.doi.org/10.1521/pedi_2018_32_340
N.B. These documents automatically identified may not have been verified by the study sponsor.