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Trial registered on ANZCTR


Registration number
ACTRN12612000951853
Ethics application status
Approved
Date submitted
4/09/2012
Date registered
5/09/2012
Date last updated
7/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A clinical trial of Mentalization Based Therapy treatment for Borderline Personality disorder
Scientific title
Outcome effects of a Mentalization Based Treatment service (Mindsight) for people with Borderline Personality disorder in urban Christchurch: a clinical trial and evaluative study
Secondary ID [1] 281157 0
None
Universal Trial Number (UTN)
U1111-1134-1847
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline personality disorder 287322 0
Condition category
Condition code
Mental Health 287657 287657 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mentalization Based Treatment psychotherapy.
The intervention group receive a weekly 50 minute individual psychotherapy session with a therapist trained in Mentalization Based Treatment methods. They also attend a 90 minute group psychotherapy session weekly. This is facilitated by 2 MBT trained therapists. They retain a case manager to co-ordinate care and have regular 6 monthly, or greater, reviews by a psychiatrist for medical care. The intervention is applied for a duration of 18 months.
Intervention code [1] 285606 0
Treatment: Other
Comparator / control treatment
The comparison group receive treatment as usual standard psychiatrist follow up of 3 - 6 monthly review, or greater. As well as standard clinical case management care follow up consisting of 30 – 60 minute sessions 2 weekly or more often if crisis intervention is necessary. Case managers recieve additional training in case management approaches to the care of people with Borderline Personality Disorder to standardise and optimise usual treatment.
Control group
Active

Outcomes
Primary outcome [1] 287905 0
Incident rate of self harm. Self harm is defined as those events which are serious in nature and requiring medical intervention. Case notes will be tracked to recover details of presentations, nature of harm, interventions required and outcome of event.
Timepoint [1] 287905 0
Baseline and at 6, 12 and 18 month after intervention commencement
Primary outcome [2] 287906 0
Incident rate of suicide attempts. Suicide events are defined as those events which are serious in nature requiring medical intervention. Case notes will be tracked to recover details of presentations, nature of suicide event, interventions required and outcome of event.
Timepoint [2] 287906 0
Baseline and at 6, 12 and 18 month after intervention commencement
Secondary outcome [1] 299031 0
Perception of quality of life. this will be measured using the Quality of Life Index, a patient self report questionnnaire will be used.
Timepoint [1] 299031 0
Baseline and at 6, 12 and 18 month after intervention commencement
Secondary outcome [2] 299032 0
Depression. Depression will be assessed using the Beck Depression Inventory, a patient self report questionnnaire.
Timepoint [2] 299032 0
Baseline and at 6, 12 and 18 month after intervention commencement
Secondary outcome [3] 299033 0
Anxiety. Anxiety will be assessed using the Speilberger State & Trait Anxiety Inventory for Adults, a patient self report questionnnaire.
Timepoint [3] 299033 0
Baseline and at 6, 12 and 18 month after intervention commencement
Secondary outcome [4] 299034 0
Social adjustment. Social adjustment will be measured using the Social Adjustment Scale, a patient self report questionnnaire.
Timepoint [4] 299034 0
Baseline and at 6, 12 and 18 month after intervention commencement
Secondary outcome [5] 299035 0
Borderline personality disorder symptoms. Symptom severity wil be measured using the Borderline Symptom Checklist (Severity Scale), a patient self report questionnnaire.
Timepoint [5] 299035 0
Baseline and at 6, 12 and 18 month after intervention commencement
Secondary outcome [6] 299036 0
Severity of other personality problems. This will be measured using the Severity Indices of Personality Problems scale, a patient self report questionnnaire.
Timepoint [6] 299036 0
Baseline and at 6, 12 and 18 month after intervention commencement
Secondary outcome [7] 299037 0
Severity of self destructive thinking. This will be measured using the Firestone Assessment of Self-Destructive Thoughts, a patient self report questionnnaire.
Timepoint [7] 299037 0
Baseline and at 6, 12 and 18 month after intervention commencement
Secondary outcome [8] 299038 0
Function of self injury. This will be measured using the Modified Ottawa Self-Injury Functions scale, a patient self report questionnnaire.
Timepoint [8] 299038 0
Baseline and at 6, 12 and 18 month after intervention commencement

Eligibility
Key inclusion criteria
Diagnosis of Borderline Personality Disorder
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Primary diagnosis of psychosis, substance dependence, insufficient ability to speak English to the degree that would inhibit the delivery of structured psychological treatment

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by using a randomization table created by a computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4528 0
New Zealand
State/province [1] 4528 0
Canterbury

Funding & Sponsors
Funding source category [1] 285932 0
University
Name [1] 285932 0
University of Otago
Address [1] 285932 0
P.O. Box 56
Dunedin 9054
Country [1] 285932 0
New Zealand
Funding source category [2] 285933 0
Government body
Name [2] 285933 0
Department of Internal Affairs
Address [2] 285933 0
P.O. Box 805
Wellington 6140
Country [2] 285933 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Christchurch
Address
P.O. Box 4345
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 284754 0
None
Name [1] 284754 0
Address [1] 284754 0
Country [1] 284754 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287958 0
Upper South B Regional Ethics committee
Ethics committee address [1] 287958 0
Ministry of Health
P.O. Box 5013
Wellington 6011
Ethics committee country [1] 287958 0
New Zealand
Date submitted for ethics approval [1] 287958 0
15/06/2009
Approval date [1] 287958 0
10/08/2009
Ethics approval number [1] 287958 0
URB/09/06/026

Summary
Brief summary
Treatment as usual (TAU) is thought to contribute to the long-standing nature of borderline personality disorder. There is increasing evidence that structured programmes of care, organised around a consistent model of care such as Mentalization Based Treatment, and delivered over the longer-term, are beneficial in reducing self-harm and suicidality; and in reducing service demand and health costs. Additionally, there is evidence that intensive treatment packages produce additional improvements in the long-term. A new MBT service for clients with BPD is introduced in Christchurch. This study will attempt to establish the benefits of investing in a specific treatment approach over more general enhancements to case managment. This comparison will also contribute to the clinical knowledge concerning the efficacy of this treatment approach in real-world scenarios.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34659 0
Address 34659 0
Country 34659 0
Phone 34659 0
Fax 34659 0
Email 34659 0
Contact person for public queries
Name 17906 0
Dr David Carlyle
Address 17906 0
Dept. Psychological Medicine
University of Otago
P.O. Box 4345
Christchurch 8011
Country 17906 0
New Zealand
Phone 17906 0
+64 03 3720400
Fax 17906 0
Email 17906 0
dave.carlyle@otago.ac.nz
Contact person for scientific queries
Name 8834 0
Dr David Carlyle
Address 8834 0
Dept. Psychological Medicine
University of Otago
P.O. Box 4345
Christchurch 8011
Country 8834 0
New Zealand
Phone 8834 0
+64 03 3720400
Fax 8834 0
Email 8834 0
dave.carlyle@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary