Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000502932
Ethics application status
Approved
Date submitted
11/05/2011
Date registered
13/05/2011
Date last updated
5/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
COMMENT Study- A pilot study of a Community-based Mentalization intervention for self-harm
Scientific title
COMMENT Study- A pilot study of a Community-based Mentalization intervention to treat recurrent deliberate self-harm in patients with Borderline Personality Disorder (BPD)
Secondary ID [1] 262150 0
Nil
Universal Trial Number (UTN)
Trial acronym
COMMENT study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder (BPD) 265829 0
Recurrent, deliberate self-harm 265851 0
Condition category
Condition code
Mental Health 265986 265986 0 0
Other mental health disorders
Public Health 266005 266005 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a proof of concept study to determine whether a mentalization-based intervention in a metropolitan community mental health service, when added to a recovery-based model of care (Strengths model) is of clinical benefit to patients at St Vincent’s Mental Health with a history of recurrent, deliberate self-harm who meet DSM-IV criteria for BPD and at least 8 of the DIB-R rating scale criteria for BPD. The hypothesised clinical benefits are reduced episodes of significant self-harm and suicidal behaviour and reduced acute presentations to the Emergency Department, acute psychiatric inpatient admissions and length of inpatient stay, in tandem with improved subjective and objective functioning over a 12 month period.
This study will be conducted with collaborative support and training in MBT from senior SPECTRUM (Victorian Statewide Personality Disorders Service) clinicians.
Mentalization-based therapy (MBT), is a psychological treatment for Borderline Personality Disorder (BPD) , whose aim is to develop a person’s capacity to focus attention on and understand thoughts and emotions, to help with more accurate interpretation of their and others’ behaviour, and in turn improve interpersonal functioning
Case managers using the MBT approach would see their patients at a frequency determined by the case manager in consultation and agreement with the patient according to their mental state and level of distress or stress. Any discordance between the case manager and patient regarding the frequency of contact will be respectfully discussed and considered by the case manager in the context of the professional relationship. This could involve several meetings per week at times of crisis. The treatment would be focussed on helping the patient reinstate mentalizing during crises. Telephone contacts would be employed and active follow-up occur if patients failed to attend appointments. The frequency of contact and meetings will be recorded. A crisis plan would be developed by the patient and the case manager. Case managers employing the MBT approach would be supervised fortnightly by a MBT trained therapist. The training for case managers employing MBT would be two half days training by SPECTRUM staff prior to study commencement. There would be an additional two hour training module, two months into the study.
The total, additional time commitment of 40 hours for case managers will be 26 hours of supervision, 10 hours of training, and up to 4 hours in focus groups over the 12 month duration of the study. The case managers’ attendance in these study-related activities will be back-filled by duty and, or additional staff.
Intervention code [1] 264566 0
Treatment: Other
Intervention code [2] 264577 0
Behaviour
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266732 0
Suicidal threats/deliberate self-harm.

Assessed by Linkage to medical record and Redevelopment of Acute and Psychiatric Information Directions (RAPID) database.
Timepoint [1] 266732 0
Entry to the study and at 3monthly intervals to 12 months, and then through 12 month follow-up.
Primary outcome [2] 266747 0
Emergency department presentations.

Assessed by Linkage to medical record and Redevelopment of Acute and Psychiatric Information Directions (RAPID) database.
Timepoint [2] 266747 0
Entry to the study and at 3monthly intervals to 12 months, and then through 12 month follow-up.
Primary outcome [3] 266748 0
Number of inpatient days.

Assessed by Linkage to medical record and Redevelopment of Acute and Psychiatric Information Directions (RAPID) database.
Timepoint [3] 266748 0
Entry to the study and at 3monthly intervals to 12 months, and then through 12 month follow-up.
Secondary outcome [1] 276272 0
HONOS (Health of the Nation Outcome Scale).

This measures the health and social functioning of people with mental illness. This 32 item instrument is mandatorily utilised and completed by treating clinicians, 3 monthly, for all public mental health patients in Australia. The instrument consists of 12 items measuring behaviour, impairment, symptoms and social functioning. This will be completed by St Vincent?s Mental Health clinicians, other than the participating case managers, who are involved in the participating patients? treatment.
Timepoint [1] 276272 0
Entry to the study and at 3monthly intervals to 12 months, and then through 12 month follow-up.
Secondary outcome [2] 276304 0
BASIS 32 (Behaviour and Symptom Identification Scale).

This is mandatorily utilised and completed whenever possible, 3 monthly, by public mental health patients in Australia. The instrument measures the symptoms and functioning difficulty via self-report over the previous two weeks. The instrument consists covers a range of dimensions, including managing day to day life, relating to other people, clinical symptoms, physical symptoms, drug and alcohol usage and level of satisfaction with life.
Timepoint [2] 276304 0
Entry to the study and at 3monthly intervals to 12 months, and then through 12 month follow-up.
Secondary outcome [3] 276305 0
WHO-QOL BREF (World Health Organizations Quality of Life instrument).

This consists of 26 items and is validated measure of quality of life, encompassing physical, psychological, social and environmental domains. This will be completed by a study investigator.
Timepoint [3] 276305 0
Entry to the study and at 3monthly intervals to 12 months, and then through 12 month follow-up.

Eligibility
Key inclusion criteria
i) For Patients:
Patients with likely/established BPD, irrespective of Axis I comorbidity.
Recurrent deliberate self-harm.

i) For Case managers:
Employed at St Vincent’s Mental Health .
Currently providing care and case management to patients of St Vincent’s Mental Health who are suffering with likely/established BPD, irrespective of Axis I comorbidity.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) For patients:
Do not suffer with likely/established BPD..
Currently being treated with MBT.

ii) For case managers:
Not currently providing care and case management to patients of St Vincent’s Mental Health who are suffering with likely/established BPD.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/06/2011
Actual
18/01/2012
Date of last participant enrolment
Anticipated
Actual
3/07/2014
Date of last data collection
Anticipated
Actual
3/07/2014
Sample size
Target
12
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11320 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Funding & Sponsors
Funding source category [1] 265048 0
Hospital
Name [1] 265048 0
St Vincent's Mental Health
Country [1] 265048 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Mental Health
Address
PO Box 2900, Fitzroy 3065, Vic.
Country
Australia
Secondary sponsor category [1] 264147 0
None
Name [1] 264147 0
Address [1] 264147 0
Country [1] 264147 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267037 0
HREC-A
Ethics committee address [1] 267037 0
Ethics committee country [1] 267037 0
Australia
Date submitted for ethics approval [1] 267037 0
Approval date [1] 267037 0
11/05/2011
Ethics approval number [1] 267037 0
1/11/0023

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

Contacts
Principal investigator
Name 32598 0
A/Prof Peter Bosanac
Address 32598 0
Level 2, 46 Nicholson St Fitzroy 3065.
Country 32598 0
Australia
Phone 32598 0
+61392314329
Fax 32598 0
Email 32598 0
[email protected]
Contact person for public queries
Name 15845 0
Dr Peter Bosanac
Address 15845 0
46 Nicholson St Fitzroy 3065, Melbourne, Vic.,Australia
Country 15845 0
Australia
Phone 15845 0
+61 3 9288 2211
Fax 15845 0
Email 15845 0
[email protected]
Contact person for scientific queries
Name 6773 0
Dr Peter Bosanac
Address 6773 0
46 Nicholson St Fitzroy 3065, Melbourne, Vic., Australia
Country 6773 0
Australia
Phone 6773 0
+613 9288 2211
Fax 6773 0
Email 6773 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
No additional documents have been identified.