Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000650998
Ethics application status
Not yet submitted
Date submitted
23/05/2011
Date registered
24/06/2011
Date last updated
24/06/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the effectiveness of body-oriented group treatment for clients diagnosed with Borderline Personality Disorder
Scientific title
Clients with moderate to severe Borderline Personality Disorder will undertake a ten-week body-oriented group therapy, with a view to reduction in BPD symptoms post treatment as compared to pre treatment.
Secondary ID [1] 262233 0
Nil
Universal Trial Number (UTN)
u1111-1121-6042
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder 267931 0
Condition category
Condition code
Mental Health 268074 268074 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Body-Mind Group Therapy (BMGT) is a body-oriented small group therapy conducted by two expereinced clinicians (one psychologist, one psychiatric nurse) as well as one experienced circus trainer. A maximum of eight clients meet for 120 min, once per week for ten weeks.
The aim is to increase body awareness through body centered movements and experiecnes in an interpersonal situation. The body movements included basic circus skills such as acrobalance, juggling, ball games and aerials.
Intervention code [1] 266624 0
Treatment: Other
Intervention code [2] 266825 0
Behaviour
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266815 0
Increase in body awareness as measured by the Body Awareness rating Scale
Timepoint [1] 266815 0
at baseline and at completion of intervention.
Secondary outcome [1] 276436 0
Reduction in dissociative expereinces as measured by Dissociative Experiences Scale
Timepoint [1] 276436 0
at baseline and at completion of intervention.

Eligibility
Key inclusion criteria
a. five or more criteria of BPD as outline by the DSM IV
Criteria include
1. frantic efforts to avoid real or imagined abandonment. Note: Do not include suicidal or self-mutilating behavior covered in Criterion 5.

2. a pattern of unstable and intense interpersonal relationships characterized by alternating between extremes of idealization and devaluation.

3. identity disturbance: markedly and persistently unstable self-image or sense of self.

4. impulsivity in at least two areas that are potentially self-damaging (e.g., spending, sex, substance abuse, reckless driving, binge eating). Note: Do not include suicidal or self-mutilating behavior covered in Criterion 5.

5. recurrent suicidal behavior, gestures, or threats, or self-mutilating behavior

6. affective instability due to a marked reactivity of mood (e.g., intense episodic dysphoria, irritability, or anxiety usually lasting a few hours and only rarely more than a few days).

7. chronic feelings of emptiness

8. inappropriate, intense anger or difficulty controlling anger (e.g., frequent displays of temper, constant anger, recurrent physical fights)

9. transient, stress-related paranoid ideation or severe dissociative symptoms

b. a registered client of a Victorian Area Mental Health Service
c. has a case manager who can arrange an inpatient admission if required
d. has a support person who can see them two weekly whilst they are in treatment
e. stated willingness to attend for ten weeks
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. current positive or negative psychotic symptoms
2. likely to interfere with the participation of others i.e., violent or threatening
3. intellectual disability or cognitive impairment significant enough to interfere with participation
4. physical disability or injury significant enought to interfere with participation

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267120 0
Government body
Name [1] 267120 0
Eastern Health
Country [1] 267120 0
Australia
Primary sponsor type
Individual
Name
Kate Cooke
Address
PO Box 135
Ringwood East
VIC 3135
Country
Australia
Secondary sponsor category [1] 264201 0
None
Name [1] 264201 0
Address [1] 264201 0
Country [1] 264201 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 267104 0
Ethics committee address [1] 267104 0
Ethics committee country [1] 267104 0
Date submitted for ethics approval [1] 267104 0
30/05/2011
Approval date [1] 267104 0
Ethics approval number [1] 267104 0

Summary
Brief summary
Spectrum, a state-wide service for treating patients with severe borderline personality disorder, has been running body-orientated group therapies since 2006. In 2009 Spectrum partnered with the Women’s Circus in Footscray to develop an outpatients Body-Mind group therapy program. Clinical observations of patients who attended this group suggest a reduction in symptoms and an increase in involvement with their bodies, sensation, feelings and emotions. This is important as patients with borderline personality disorder often dissociate and avoid difficult emotions and sensations.

We aim to evaluate the clinical effectiveness of this treatment in a small pilot research study. Patients with borderline personality disorder will be recruited from Area Mental Health Services to participate in a 10 week Body-Mind Group. These patients will continue to receive treatment as usual from their local mental health case manager while attending this group. During this group therapy, qualitative and quantitative data will be collected regarding symptom severity and group participation in order to evaluate the effectiveness of this treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32646 0
Address 32646 0
Country 32646 0
Phone 32646 0
Fax 32646 0
Email 32646 0
Contact person for public queries
Name 15893 0
Kate Cooke
Address 15893 0
Eastern Health
PO Box 135
Ringwood East
VIC 3135
Country 15893 0
Australia
Phone 15893 0
+61 03 9871 3900
Fax 15893 0
Email 15893 0
kate.cooke@easternhealth.org.au
Contact person for scientific queries
Name 6821 0
Kate Cooke
Address 6821 0
Eastern Health
PO Box 135
Ringwood East
VIC 3135
Country 6821 0
Australia
Phone 6821 0
+61 03 9871 3900
Fax 6821 0
Email 6821 0
kate.cooke@easternhealth.org.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
No additional documents have been identified.