Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000206527
Ethics application status
Approved
Date submitted
16/03/2006
Date registered
29/05/2006
Date last updated
29/05/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Process and outcome of acceptance based outpatient skills training groups for people with four or more criteria of borderline personality disorder
Scientific title
The effect of Acceptance and Commitment Therapy/Dialectical Behaviour Therapy outpatient skills training groups for people with four or more criteria of borderline personality disorder on borderline symptoms, quality of life, hopelessness, acceptance of emotions and mindfulness.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Four or more criteria of Borderline Personality Disorder 1184 0
Condition category
Condition code
Mental Health 1267 1267 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 1 is a 12 week two hours per week acceptance-based crisis skills training group. Clients have the option of continuing to Phase 2 which consists of an additional 30 weeks of skills training groups covering interpersonal skills, emotion regulation skils and mindfulness skills. The groups are a combination of Acceptance and Commitment Therapy and Dialectical Behaviour Therapy interventions iin the context of Acceptance and Commitment Therapy principles of treatment.
Intervention code [1] 925 0
Treatment: Other
Comparator / control treatment
No comparator.
Control group
Active

Outcomes
Primary outcome [1] 1708 0
The study is designed to evaluate the effectiveness of the phase 1 and phase 2 groups in reducing psychopathology. It is predicted that it will be mediated by processes predicted from Acceptance and Commitment Therapy including improved emotion regulation, increased acceptance of thoughts and feelings, decreased fear of emotion and increased commitment to positive change.
Timepoint [1] 1708 0
Measured pre-treatment. mid-treatment and at the end of treatment for each of four treatment modules. They will also be assessed at the start of the waiting list period for the waiting list control group. There will also be a three month follow up.
Primary outcome [2] 1709 0
The study is designed to evaluate the effectiveness of the phase 1 and phase 2 groups in reducing targeted crisis related problem behaviours eg self-harm. It is predicted that it will be mediated by processes predicted from Acceptance and Commitment Therapy including improved emotion regulation, increased acceptance of thoughts and feelings, decreased fear of emotion and increased commitment to positive change.
Timepoint [2] 1709 0
Measured pre-treatment. mid-treatment and at the end of treatment for each of four treatment modules. They will also be assessed at the start of the waiting list period for the waiting list control group. There will also be a three month follow up.
Primary outcome [3] 1710 0
The study is designed to evaluate the effectiveness of the phase 1 and phase 2 groups in improving quality of life. It is predicted that it will be mediated by processes predicted from Acceptance and Commitment Therapy including improved emotion regulation, increased acceptance of thoughts and feelings, decreased fear of emotion and increased commitment to positive change.
Timepoint [3] 1710 0
Measured pre-treatment. mid-treatment and at the end of treatment for each of four treatment modules. They will also be assessed at the start of the waiting list period for the waiting list control group. There will also be a three month follow up.
Primary outcome [4] 1711 0
The study is designed to evaluate the effectiveness of the phase 1 and phase 2 groups in improving overall functioning. It is predicted that it will be mediated by processes predicted from Acceptance and Commitment Therapy including improved emotion regulation, increased acceptance of thoughts and feelings, decreased fear of emotion and increased commitment to positive change.
Timepoint [4] 1711 0
Measured pre-treatment. mid-treatment and at the end of treatment for each of four treatment modules. They will also be assessed at the start of the waiting list period for the waiting list control group. There will also be a three month follow up.
Secondary outcome [1] 3062 0
Reduced utilisation of crisis emergency and inpatient services.
Timepoint [1] 3062 0
These will be measured pre-treatment. mid-treatment and at the end of treatment for each of four treatment modules. They will also be assessed at the start of the waiting list period for the waiting list control group. There will also be a three month follow up. Also measured will be consumer satisfaction and satisfaction of referring staff .

Eligibility
Key inclusion criteria
Referrals will be accepted of clients who meet the following criteria: 1)four or more criteria of BPD; 2)a registered client of an AMHS; 3) has a case manager, or other identified AMHS staff contact person who can arrange an inpatient admission or crisis team visit if required; 4)has a support person who can assist them in practicing the skills: e.g. an AMHS or Community Health Centre clinician, GP, or private psychiatrist; 5)stated willingness to attend regularly for 12 sessions.
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 (other than reactive psychotic symptoms associated with borderline personality disorder);2)likely to significantly interfere with the participation of others e.g. violent or threatening;3)intellectual disability, or cognitive impairment severe enough to interfere with participation.

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 phone/fax
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation sequence in blocks will be generated via programs available at randomization.com
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1388 0
Commercial sector/Industry
Name [1] 1388 0
Spectrum
Country [1] 1388 0
Primary sponsor type
Commercial sector/Industry
Name
Spectrum
Address
Country
Australia
Secondary sponsor category [1] 1221 0
None
Name [1] 1221 0
No
Address [1] 1221 0
Country [1] 1221 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2738 0
Eastern Health
Ethics committee address [1] 2738 0
Ethics committee country [1] 2738 0
Australia
Date submitted for ethics approval [1] 2738 0
Approval date [1] 2738 0
Ethics approval number [1] 2738 0
214/06
Ethics committee name [2] 2739 0
Werribee Mercy Health Service
Ethics committee address [2] 2739 0
Ethics committee country [2] 2739 0
Australia
Date submitted for ethics approval [2] 2739 0
Approval date [2] 2739 0
Ethics approval number [2] 2739 0
Ro6/05W
Ethics committee name [3] 2740 0
North West Mental Health
Ethics committee address [3] 2740 0
Ethics committee country [3] 2740 0
Australia
Date submitted for ethics approval [3] 2740 0
Approval date [3] 2740 0
Ethics approval number [3] 2740 0
2006.016

Summary
Brief summary
Borderline Personality Disorder (BPD) is a disabling syndrome which is generally associated with a history of severe childhood trauma and/or neglect. The disorder is characterized by intense, distressing and changeable emotions, impulsive self-destructive behaviour and troubled relationships. Around three quarters of the people with this diagnosis engage in deliberate self-harm (such as cutting or burning themselves) and around eight to ten percent suicide. Treatment of the condition is difficult because of stormy relationships with treating staff and staff anxiety about clients’ suicidality and self-harm.
Spectrum is a statewide public sector specialist service, which was established to support the treatment of clients with BPD. Since its inception eight years ago, Spectrum has provided consultation and training to staff, and residential treatment for a small number of clients. Spectrum has been examining ways of offering treatment for a larger number of clients. A difficulty has been the need to do this within Spectrum’s current level of resourcing and that of the Area Mental Health services. Group treatment is, in general a particularly cost effective approach, and has the added benefit of providing an opportunity for clients to expand their social networks. Our aim is to develop a group treatment approach for BPD that can eventually be delivered by area clinicians with Spectrum support.

Recently a brief outpatient group treatment was trialed in America and found to be very successful in treating the symptoms of BPD. The groups aimed to teach clients ways of managing their troubling emotions in crises so as to reduce impulsive self-destructiveness. The approach used in that study has many similarities to Spectrum’s residential treatment, and to a group outpatient treatment piloted by Spectrum in 2005. The very positive findings of the American study have lent support to our decision to continue testing a similar outpatient group treatment.

The project has two phases. In phase one a 12 week series of groups teaching Crisis Skills will be trialed. For some clients this 12 week group treatment (with ongoing individual treatment) will be enough. For those who require more group treatment, additional skills training will be offered in phase two. Phase two will consist of three further series of groups (each lasting 10 weeks), teaching Interpersonal Skills, Emotion Skills and Mindfulness Skills. Clients who enter phase two treatment will thus be provided with the opportunity for approximately a year of group treatment in total (including phases 1 and 2 and short breaks between modules of treatment).

Sixty clients will be recruited into phase 1, via referrals from staff from AMHS staff in Eastern Health, Northwest Mental Health and the Werribee-Mercy Networks. All clients will need to have a support person who can assist them in practicing the skills: e.g. an AMHS or Community Health Centre clinician, GP, or private psychiatrist. These clinicians will receive information and support to assist them in their role.Clients will be invited to attend an information session and a screening interview with one of the Spectrum clinicians and a diagnostic interview with a research assistant. Informed consent will be obtained at the screening interview. Half the clients will be randomly allocated to start phase 1 groups immediately, and the remainder to start after three months. When all clients have been offered the phase 1 groups, phase 2 groups will be offered to all clients.

In order to evaluate the treatment, and better understand how it works, clients who consent, will be asked to complete questionnaires before the first group of each series, mid-way through each group series, after the last group of each series, and at three month follow up. Phase 1 treatment will be evaluated by comparing the changes in the first 30 clients treated with the 30 clients on the waiting list, and by comparing test results, for all clients before and after phase 1 treatment. Outcomes from the combined phase 1 and phase 2 groups will also be evaluated, and the process of change examined.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36130 0
Address 36130 0
Country 36130 0
Phone 36130 0
Fax 36130 0
Email 36130 0
Contact person for public queries
Name 10114 0
Jane Morton
Address 10114 0
Spectrum
PO Box 135
Ringwood East VIC 3135
Country 10114 0
Australia
Phone 10114 0
+61 3 98713900
Fax 10114 0
+61 3 98713911
Email 10114 0
[email protected]
Contact person for scientific queries
Name 1042 0
Elise Guymer
Address 1042 0
Spectrum
PO Box 135
Ringwood East VIC 3135
Country 1042 0
Australia
Phone 1042 0
+61 3 98713900
Fax 1042 0
+61 3 98713911
Email 1042 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.