ANZCTR - Registration

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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]

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

Condition category

Condition code

Mental Health

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]

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]

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]

Baseline and at 6, 12 and 18 month after intervention commencement

Primary outcome [2]

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]

Baseline and at 6, 12 and 18 month after intervention commencement

Secondary outcome [1]

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]

Baseline and at 6, 12 and 18 month after intervention commencement

Secondary outcome [2]

Depression. Depression will be assessed using the Beck Depression Inventory, a patient self report questionnnaire.

Timepoint [2]

Baseline and at 6, 12 and 18 month after intervention commencement

Secondary outcome [3]

Anxiety. Anxiety will be assessed using the Speilberger State & Trait Anxiety Inventory for Adults, a patient self report questionnnaire.

Timepoint [3]

Baseline and at 6, 12 and 18 month after intervention commencement

Secondary outcome [4]

Social adjustment. Social adjustment will be measured using the Social Adjustment Scale, a patient self report questionnnaire.

Timepoint [4]

Baseline and at 6, 12 and 18 month after intervention commencement

Secondary outcome [5]

Borderline personality disorder symptoms. Symptom severity wil be measured using the Borderline Symptom Checklist (Severity Scale), a patient self report questionnnaire.

Timepoint [5]

Baseline and at 6, 12 and 18 month after intervention commencement

Secondary outcome [6]

Severity of other personality problems. This will be measured using the Severity Indices of Personality Problems scale, a patient self report questionnnaire.

Timepoint [6]

Baseline and at 6, 12 and 18 month after intervention commencement

Secondary outcome [7]

Severity of self destructive thinking. This will be measured using the Firestone Assessment of Self-Destructive Thoughts, a patient self report questionnnaire.

Timepoint [7]

Baseline and at 6, 12 and 18 month after intervention commencement

Secondary outcome [8]

Function of self injury. This will be measured using the Modified Ottawa Self-Injury Functions scale, a patient self report questionnnaire.

Timepoint [8]

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

Sex

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

1/09/2009

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

72

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago

Address [1]

P.O. Box 56
Dunedin 9054

Country [1]

New Zealand

Funding source category [2]

Government body

Name [2]

Department of Internal Affairs

Address [2]

P.O. Box 805
Wellington 6140

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Upper South B Regional Ethics committee

Ethics committee address [1]

Ministry of Health
P.O. Box 5013
Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

15/06/2009

Approval date [1]

10/08/2009

Ethics approval number [1]

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

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Dr David Carlyle

Address

Dept. Psychological Medicine
University of Otago
P.O. Box 4345
Christchurch 8011

Country

New Zealand

Phone

+64 03 3720400

Fax

Email

dave.carlyle@otago.ac.nz

Contact person for scientific queries

Name

Dr David Carlyle

Address

Dept. Psychological Medicine
University of Otago
P.O. Box 4345
Christchurch 8011

Country

New Zealand

Phone

+64 03 3720400

Fax

Email

dave.carlyle@otago.ac.nz

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

Source	Title	Year of Publication	DOI
Embase	A Randomized-Controlled Trial of Mentalization-Based Treatment Compared With Structured Case Management for Borderline Personality Disorder in a Mainstream Public Health Service.	2020	https://dx.doi.org/10.3389/fpsyt.2020.561916

N.B. These documents automatically identified may not have been verified by the study sponsor.