ANZCTR - Registration

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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

Condition category

Condition code

Mental Health

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]

Treatment: Other

Comparator / control treatment

No comparator.

Control group

Active

Outcomes

Primary outcome [1]

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]

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]

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]

Primary outcome [3]

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]

Primary outcome [4]

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]

Secondary outcome [1]

Reduced utilisation of crisis emergency and inpatient services.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Spectrum

Address [1]

Country [1]

Primary sponsor type

Commercial sector/Industry

Name

Spectrum

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Eastern Health

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

214/06

Ethics committee name [2]

Werribee Mercy Health Service

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

Ethics approval number [2]

Ro6/05W

Ethics committee name [3]

North West Mental Health

Ethics committee address [3]

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

Ethics approval number [3]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Jane Morton

Address

Spectrum
PO Box 135
Ringwood East VIC 3135

Country

Australia

Phone

+61 3 98713900

Fax

+61 3 98713911

[email protected]

Contact person for scientific queries

Name

Elise Guymer

Address

Spectrum
PO Box 135
Ringwood East VIC 3135

Country

Australia

Phone

+61 3 98713900

Fax

+61 3 98713911

[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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically