Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001154392p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
21/05/2026
Date registered
Help: Date registered
17/09/2026
Date last updated
Help: Date last updated
17/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
17/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Good Psychiatric Management-based post-crisis support for people diagnosed with BPD leaving emergency care
Scientific title
Alternatives to the Emergency Department: Evaluating the feasibility, acceptability and appropriateness of Good Psychiatric Management-based post-crisis support for people with borderline personality disorder
Additional trial identifiers [1] 317231 0
Nil
Universal Trial Number (UTN)
Trial acronym
Alt to ED
Related trial records

Health condition
Health condition(s) studied:
borderline personality disorder 341843 0
Condition category
Condition code
Mental Health 337906 337906 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Good Psychiatric Management (GPM) is an evidence-based treatment for borderline personality disorder (BPD) that can be administered by generalist or non-specialist clinicians with minimal training and is designed to be flexible and adaptable to patients’ needs. GPM combines psychoeducation, crisis planning, case management and strategies to enhance engagement with family and community supports. It emphasises collaborative, person-centred care.

In this study, people diagnosed with BPD with a history of more than one presentation (including the current presentation) to an Eastern Health emergency department (ED) for a mental health-related crisis will be offered a 10-session, 1-hour-each GPM intervention as step-down post-crisis support over 6 months. A clinician trained in GPM will provide the sessions. The nominated clinician will receive formal training from Spectrum. Spectrum is a public mental health service in Victoria specialising in the treatment of people with personality disorders and complex trauma histories. Since Spectrum has extensive expertise in training non-specialist clinicians in GPM, this is considered appropriate and feasible. Throughout treatment delivery, the clinician will also receive ongoing individual supervision from a senior Spectrum clinician to support intervention fidelity.

Training:

1. The nominated clinician will receive 1:1 training in GPM foundations (basic) from a senior GPM-trained clinician at Spectrum via videoconference (Zoom/Microsoft Teams). This will be followed by advanced training in "Working with complex presentations of BPD & coexisting conditions using GPM", a group in-person workshop at Spectrum delivered by two senior clinicians with extensive experience in working with complex presentations of people with BPD.
2. The 1:1 training will be split into four sessions each week (2 hours each, totalling up to 8 hours) in September preceding the group workshop. The group workshop will occur on 22nd October.
3. The Spectrum clinicians have previous experience in providing this training; materials generally used to provide GPM trainings at Spectrum will be utilised. This may include pre-prepared slides, training outlines and pre-recorded videos. Modifications to the content/pace will be made as necessary, based on the nominated clinician's level of experience, study context and skills.
4. The trainings will occur in September (basic) and October (advanced). Intervention is anticipated to start in November.

Content covered in the training -

Basic:
Management strategies using practicality, good sense, and flexibility are emphasised. Listening, validation, judicious self-disclosures, and advisement to build a life rather than focus on being a patient create a positive relationship in which both the concerns and limitations of a mental health professional are explicit. Techniques and interventions that facilitate the patient’s trust and willingness to become a proactive collaborator will be described. Guidelines for managing the common and usually most burdensome issues of managing suicidality and self-harm (e.g., intersession crises, threats as a call-for-help, excessive use of ER’s or hospitals) will be reviewed. Principles for the management of co-occurring disorders and medications from an evidence-based point of view are presented pragmatically. How and when psychiatrists can usefully integrate group, family, or other psychotherapies will be described.

Advanced:

This workshop will provide instruction in how to adapt GPM to meet the needs of patients with significant co-occurring disorders along with BPD. Depression, anxiety, posttraumatic stress disorder, substance abuse disorder, eating disorders, other personality disorders, and many other disorders frequently co-occur with BPD and can significantly complicate treatment. Many providers believe that co-occurring disorders must be treated before BPD can be addressed, or that BPD must be addressed before meaningful change can occur in co-occurring disorders. This workshop will equip attendees to consider patients with complex cases as whole people and use GPM to most effectively help them. It will review the common co-occurring disorders, the way they interact with BPD, and strategies for combined treatment.

The intervention sessions will focus on the following treatment goals:

1. Creating and reviewing a safety narrative: Working with the clinician to understand what helps and what doesn’t help when the patient is experiencing heightened and painful emotions.

2. Developing a clinical formulation: The clinician will work with the patient to make sense of the challenges they experience, history, and patterns of responding so that everyone in the patient's treating team understands what’s going on.

3. Providing trauma-informed care: Recognising how past trauma may affect current emotions and behaviour and responding compassionately.

4. Educating the person about the symptoms they are experiencing: Helping the patient to understand their diagnosis, symptoms, and why they feel and react the way they do.

5. Managing crises: Supporting the patient during emotional crises and helping them develop alternative coping strategies.

6. Strengthening family and community supports: Encouraging the involvement of supportive people and connecting the patient with helpful services.

7. Finding alternatives to self-damaging coping mechanisms: Working together to discover less-harmful ways to manage distressing emotions.

Clinicians in Eastern Health ED/crisis assessment and treatment units (CATT)/ psychiatric assessment and planning unit (PAPU) will identify the people most likely to benefit from this intervention and refer them to the GPM clinician within 1 week of their ED presentation. The GPM clinician will deliver the intervention either online or face-to-face on an Eastern Health site over 6 months, in intervals scheduled according to the patient's preferences or needs.

Adherence to the intervention will be monitored by collecting data about participants' level of engagement using the Treatment Engagement Rating (TER) scale, administered by the clinician every fortnight while the patient is engaged in treatment. Adherence to the intervention by the clinician will be monitored using the GPM adherence scale (GPM-AS), rated by the clinical supervisor for the GPM clinician every 5 weeks throughout the treatment delivery period. Data on the frequency of emergency department (ED) presentations, including 8-hour-to-bed and 4-hour NEAT metrics*, will also be collected.

*In Australian hospitals, time-based performance measures are used to monitor ED patient flow and overcrowding. The National Emergency Access Target (NEAT) is a 4-hour target, referring to the proportion of ED patients who are admitted, discharged or transferred within 4 hours of presentation (4-hour NEAT metric). “Access block” is commonly defined as occurring when a patient who requires hospital admission remains in the ED for more than 8 hours because an inpatient bed is unavailable (8-hour to bed metric).
Intervention code [1] 334001 0
Treatment: Other
Intervention code [2] 334634 0
Behaviour
Description of the comparator or control
No comparator group will be used in this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 345351 0
Feasibility - composite outcome measured using three different scales for feasibility perceptions among staff, patients and the GPM clinician.
Timepoint [1] 345351 0
FIM: Baseline data will be collected in the first two weeks of implementation (assessment, recruitment, referral of patients from ED/CATT/PAPU to the GPM clinician). At the end of the implementation (once 15 patients have been recruited to receive the GPM intervention), FIM data will be collected again. This may be 14 to 26 weeks depending upon the rate of recruitment. TER: Fortnightly while engaged in treatment from baseline until the last treatment session (10th session), which may be 18-26 weeks from baseline depending on the interval between sessions. GPMAS: Every 5 weeks throughout the treatment delivery period of the study. This may be 26 to 37 weeks depending on the rate of recruitment and interval between sessions.
Primary outcome [2] 345777 0
Acceptability of the intervention. This is a composite outcome measured from both the clinician and patient perspectives.
Timepoint [2] 345777 0
AIM: Baseline data will be collected in the first two weeks of implementation (assessment, recruitment, referral of patients from ED/CATT/PAPU to the GPM clinician). At the end of the implementation (once 15 patients have been recruited to receive the GPM intervention), AIM data will be collected again. This may be 14 to 26 weeks depending upon the rate of recruitment. TFA: At the start (baseline, 1st session) and end of treatment (18-24 weeks post baseline, 10th session)
Primary outcome [3] 346482 0
Appropriateness of the intervention
Timepoint [3] 346482 0
Baseline data will be collected in the first two weeks of implementation (assessment, recruitment, referral of patients from ED/CATT/PAPU to the GPM clinician). At the end of the implementation (once 15 patients have been recruited to receive the GPM intervention), IAM data will be collected again. This may be 14 to 26 weeks depending upon the rate of recruitment.
Secondary outcome [1] 461357 0
Data on ED presentations
Timepoint [1] 461357 0
Twelve months before intervention commences and twelve months after intervention completion.
Secondary outcome [2] 461358 0
Perceived level of social support
Timepoint [2] 461358 0
At the start (baseline) and end of treatment (18-24 weeks post-baseline; 10th session), and 3 months post-discharge (31 to 37 weeks post-baseline)

Eligibility
Key inclusion criteria
PARTICIPANTS:

Description of staff participants:

Up to fifteen staff will be recruited from EH EDs, CATT, or PAPU over three months. Participants will include EH staff involved in the implementation (patient assessment, recruitment and referral) of the discharge pathway – ED to GPM-based post-crisis support. This may include clinicians, nurses or administrative staff.

Description of patient participants
Up to 15 participants will be recruited from EH EDs, CATT and PAPU and referred by clinical staff at EH to a GPM clinician. Participants will be adults with a diagnosis of BPD who have previously presented to an EH ED during a mental health crisis.

Inclusion criteria include patients who are:
1) Over 18 years of age
2) Have had more than one presentation (including the current presentation) to an Eastern Health ED for an acute mental health crisis and have an established diagnosis of BPD
3) Patients whose acute psychiatric needs have been addressed by CATT or PAPU (including people presenting with acute suicide risk) and who no longer require urgent acute psychiatric intervention
4) Fluent in written and spoken English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Exclusion criteria include:
1) Patients without a diagnosis of BPD
2) Patients with a diagnosis of autism spectrum disorder
3) Patients with a primary diagnosis of a mood disorder
4) Patients who are unable to provide informed consent (e.g., people with an intellectual disability)
5) Significant clinical complexities or severe co-occurring disorders, including severe alcohol or drug use or acute psychosis

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
Statistical methods / analysis
SAMPLE SIZE AND STATISTICAL OR POWER ISSUES

This study utilises a pilot design as there are no prior studies of GPM interventions delivered as brief post-crisis support for people diagnosed with BPD. We will recruit a sample of 15 patients and 15 staff. Recruitment of the planned sample size is achievable within the recruitment window based on the available clinical capacity and service throughput. Typically, a sample size of twelve is considered sufficient for pilot feasibility studies in clinical and translational research (30). Since pilot studies are not meant for statistical hypothesis testing, confidence interval estimates of the preliminary clinical outcomes will inform power calculations for a future clinical trial.

DATA ANALYSIS:
This pilot study is a small-scale mixed-methods study. While primarily assessing the feasibility, acceptability and appropriateness of the intervention within a public mental health service, the study also includes preliminary outcomes designed to measure efficacy. A wide range of outcomes (Table 1) will be measured before, during and after the GPM intervention for both staff and patient participants. The staff participant outcomes will include perceived feasibility, acceptability, and appropriateness of the intervention. Quantitative data from the outcomes will be analysed using descriptive statistics and exploratory within-person comparisons, with inferential tests interpreted cautiously due to limited power. Qualitative data collected from staff participants using open-ended questions regarding the feasibility, acceptability and appropriateness of the intervention will provide additional insights into any expansion of GPM implementation within EH EDs and crisis services. These will be analysed using content analysis and used to explain quantitative scores.
The patient participant outcomes include both self- and clinician-assessed measures of acceptability, treatment engagement and perceived social supports alongside objective data on the frequency of ED presentations and associated service use, yielding complementary insights. Analyses will rely on descriptive statistics and exploratory within-person comparisons, with any inferential tests interpreted cautiously due to limited power. Generalised comparisons of ED presentations before and after intervention for study participants will be conducted to assess differences in 8-hour access block and 4-hour NEAT metrics. Although this approach may provide limited information regarding the longer-term efficacy of the intervention, we anticipate that the preliminary data can be incorporated into future funding applications for a larger-scale randomised controlled trial.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2026
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 29491 0
Eastern Health - Box Hill
Recruitment hospital [2] 29958 0
Maroondah Hospital - Ringwood East
Recruitment postcode(s) [1] 45808 0
3128 - Box Hill
Recruitment postcode(s) [2] 46322 0
3135 - Ringwood East

Funding & Sponsors
Funding source category [1] 321808 0
Charities/Societies/Foundations
Name [1] 321808 0
Eastern Health Foundation
Country [1] 321808 0
Australia
Primary sponsor type
Other
Name
Spectrum Personality Disorder and Complex Trauma Service
Address
Country
Australia
Secondary sponsor category [1] 324658 0
None
Name [1] 324658 0
Address [1] 324658 0
Country [1] 324658 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 320352 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 320352 0
Ethics committee country [1] 320352 0
Australia
Date submitted for ethics approval [1] 320352 0
01/06/2026
Approval date [1] 320352 0
Ethics approval number [1] 320352 0

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

Contacts
Principal investigator
Name 150190 0
Prof Sathya Rao
Address 150190 0
Spectrum Personality Disorder and Complex Trauma Service, Level 1, 110 Church Street, Richmond, VIC 3121
Country 150190 0
Australia
Phone 150190 0
+61 417 560 979
Fax 150190 0
Email 150190 0
[email protected]
Contact person for public queries
Name 150191 0
Dr Karthika Kasiviswanathan
Address 150191 0
Spectrum Personality Disorder and Complex Trauma Service, Level 1, 110 Church Street, Richmond, VIC 3121
Country 150191 0
Australia
Phone 150191 0
+61 03 8413 8717
Fax 150191 0
Email 150191 0
[email protected]
Contact person for scientific queries
Name 150192 0
Dr Karthika Kasiviswanathan
Address 150192 0
Spectrum Personality Disorder and Complex Trauma Service, Level 1, 110 Church Street, Richmond, VIC 3121
Country 150192 0
Australia
Phone 150192 0
+61 03 8413 8717
Fax 150192 0
Email 150192 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.