Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000849796
Ethics application status
Approved
Date submitted
31/05/2022
Date registered
16/06/2022
Date last updated
15/08/2023
Date data sharing statement initially provided
16/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a Short-Term Group Therapy Program for People with a diagnosis of Borderline Personality Disorder
Scientific title
Effectiveness, Appropriateness, and Acceptability of a Short-Term Group Therapy Program for People with a diagnosis of Borderline Personality Disorder: The Road Maps Pilot Study
Secondary ID [1] 307258 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder 326516 0
Condition category
Condition code
Mental Health 323779 323779 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Roadmaps: A Short Therapy Group

The Borderline Personality Disorder Collaborative (BPD Co) developed Road Maps as a 12 week therapy group for people with a diagnosis of Borderline Personality Disorder (BPD). Road Maps is based on the common factors in effective treatments for BPD. Weinberg et al. (2010) and Bateman, Gunderson and Mulder (2015) have identified a number of common factors that are present in all of the evidence-based treatments for BPD. These include:

- Structured (manual directed) approach that provides a clear treatment frame
- Encouragement of person assuming control of themselves (developing sense of agency)
- Active therapists that are responsive and validating
- Engaging in exploratory interventions that connect feelings, event, actions and thoughts
- Engaging in change orientated interventions
- Therapists discusses cases, including personal reactions, with others

The BPD Foundation also identifies common factors for Effective Treatment for BPD based on the NHMRC Guidelines (2012). These include:

- Provision of information to clients and their support network
- Develop understanding of thoughts, feelings and behaviours and how these are linked
- Explore situations that lead to distress
- Teach less harmful skills for managing distress
- Develop a collaborative management plan
- Promote autonomy
- Build and maintain motivation
- Help regain and maintain interests, vocation and relationships

In general, Road Maps aims to emphasise the connection between vulnerabilities, events, feelings, thoughts and actions. This therapeutic group assists participants to build agency and be active in their own lives, whilst developing targeted coping strategies to tolerate distress.

Throughout the sessions, chain analysis (also known as functional analysis) is used to explore different aspects of participants’ experiences. The chain analysis technique has been adapted to a more engaging format, aimed at appealing to a wider audience (youth, adults, parents, country located, Aboriginal Communities and criminal justice) and reflect a person’s whole journey (past, current, and future).

Throughout the 12 sessions, participants will develop their personalised road maps which reflect their story, including where they have come from (background), current patterns (chain analysis) and ways that they can change these patterns for the future (solution analysis).

At the commencement of the trial Road Maps targeted three populations. Initially groups were delivered to adults (age 19+) and youth (16-18 years). A third population, consumers of Regional Local Health Networks (LHNs) consisted of rural consumers and group is delivered via videoconferencing. In 2023 a fourth population, criminal justice (Road Maps - In the Driver's Seat) was added to the trial for people with borderline symptoms in the community with a recent history of offending.

Road Maps also offers a carers session (2-2.5 hours long) which aims to provide carers with psychoeducation about the BPD diagnosis, safety planning (i.e. carer plan) and familiarisation of key components of the course so they can support their loved one.

All groups are facilitated by two Senior Mental Health clinicians within the scope of their clinical duties at BPD Co.

Basic Structure:

Sessions and Frequency
The Adult, Regional Online, & Criminal Justice groups consist of 12 sessions presented over 12 weeks. The Youth group runs for 10 weeks and is aligned with the school terms.

Duration of Sessions
Adult, regional online & criminal justice sessions run for 2.5 hours, including a 15-minute break. Youth sessions run for 2 hours, with a similar break. The carer session runs for approximately 2 hours (including a 15-minute break).

Group Size
Group size will depend on group context (e.g., adult, youth, via Digital Telehealth Network (DTN or zoom) etc.). However, given that there are often a proportion of people who are assessed but do not attend the group, there is a target of 12 participants for groups delivered face-to-face. Ideally, groups will retain 7 - 10 participants.

Group Delivery Modality
Road Maps was designed so that the Adult, Youth and Criminal Justice groups would be delivered face-to-face in a clinical environment (e.g. Borderline Personality Disorder Collaborative or a partnering mental health team). Regional groups are delivered online to increase accessibility to those in rural and remote regions. However, given the cooccurrence of the global pandemic with the commencement of the evaluation, adaptations have been required at times. As such some groups, depending on local ‘lock downs’, have had to be delivered online for part of the term. Mode of delivery has been recorded so this can be explored/controlled for in the analysis where possible. In stating this, the data from the regional online group will only be compared to groups that occur in a face-to-face environment for the full term.

Initial Assessment
A one-on-one initial assessment session is conducted with a Senior Mental Health Clinician. Initial assessments generally occur in the 6 weeks prior to the next group commencing. BPD Co is a clinical service and there are generally long waitlists for therapy programs. Assessments are offered in a rolling capacity as determined by referral rates and clinical resource availability. Consumers who consent to research and are assessed greater than 4 weeks before the group commences will be included in the ‘naturalistic waitlist condition’. If the initial assessment occurs within 4 weeks of the start date of the next group their data are included in the intervention condition. Consumers in the waitlist condition are asked to complete an assessment before the first group session commences. The assessment incorporates the following:

- Introduce self and profession, explain confidentiality, right to feedback
- Introduce research project, provide project information sheet and obtain consent where willing. Consumers are still eligible for the group even if research consent is not provided.
- Check that demographic information is current and up-to-date
- Conduct discipline specific assessment. Utilise BPD screener (which includes McLean’s Screening instrument for BPD (MSI-BPD) on page 1) to guide assessment of BPD criteria. Record clinician assessment of whether the person meets criteria on page 2 (Clinician assessment of DSM-V BPD criterion)
- Link assessment to goals and participation in group
- Discuss structure and expectations of group participation
- Conduct risk assessment
- Assess any barriers to participation (learning issues/behaviour/tech)
- Develop plan for any potential distress in group if required
- Develop escalation steps for acute risk presentations during group
- Offer/decline group participation; provide logistical information regarding group
- Discuss carer session
- Check evaluation tools have been completed

Group Allocation
As per clinical practice, the initial assessments for all prospective participants are reviewed at a multi-disciplinary team (MDT) clinical review including psychiatry. This is a clinical process independent of the research team. Consumer suitability for the group is determined within this process and if deemed suitable consumers generally will be offered a place in the next available group up to a cap of 12 participants. A consumer's decision to consent to the research or not, does not impact their access to the group. Allocation to the naturalistic waitlist condition (e.g., resulting in a request to complete an additional assessment at the end of the waitlist period) occurs if the person was assessed greater than 4 weeks prior to the first session of group. It does not impact on the participants access to clinical services.

Session Structure
Each session will follow the same basic structure to maintain consistency and security for participants as outlined below:

Opening Mindfulness Exercise: 10 min
Review of Previous Session and Discussions of Practice Task: 30-45 min
Session Introduction: 5 min
Discuss New Content: 70-80 min
Break*: 15 min
Introduce Practice Tasks for the Week: 5 min
End of Session Reflection Exercise / Preview next session: 5 min
Total Time: 170-180 min

Group Materials
Participant handouts have been designed specifically for Road Maps and may be provided as a workbook or weekly handouts. The materials are not yet available to the public.

Carer Session
Road Maps also offers a single carers session (2-2.5 hours long) which aims to provide carers with psychoeducation about the BPD diagnosis, safety planning (i.e. carer plan) and familiarisation of key components of the course so they can support their loved one. The carer is nominated by the consumer. The metropolitan groups are delivered face-to-face at BPD Co, and may be after hours where needed, to ensure they are accessible. The Carer sessions are delivered online in for the regional group. The metropolitan groups may be provided online if necessitated by density limits or emergency directives. There is no cap on the number of carers in each session. The carer-only session is preferably delivered within the first 4 weeks of when Road Maps group commences.

Adherence:
The content of each session is presented utilising standardised PowerPoint sessions to ensure that content is delivered in a consistent manner. After each group session is completed, facilitators are strongly encouraged to commit 15 min to debriefing about the session. A facilitator debrief form is included in the manual to guide the discussion.
Intervention code [1] 323698 0
Behaviour
Intervention code [2] 323757 0
Treatment: Other
Comparator / control treatment
Participants in the naturalistic waitlist control group are not provided any specific treatment while on the waitlist. Allocation to the naturalistic waitlist condition (e.g. resulting in a request to complete an additional assessment at the end of the waitlist period) occurs if the person was assessed greater than 4 weeks prior to the first session of group. The time of initial assessment is not allocated and may occur naturally as a function of when the person was referred and the availability of clinical resources to conduct the initial assessment which occur in a rolling manner. It does not impact on the participants access to the group programme and they can continue to access the supports they normally would (e.g. GP consultations, private psychology, support groups etc) when waiting for the next available group to commence.
Control group
Active

Outcomes
Primary outcome [1] 331539 0
Change in borderline symptom severity assessed using the Borderline Symptom List - 23 (BSL-23)
Timepoint [1] 331539 0
Baseline, first session of group (waitlist comparison only), after final session of group (primary timepoint), and 6 months post final session of group.
Primary outcome [2] 331540 0
Change in impulsive and self-destructive behaviour assessed using the Borderline Symptom List Behavioural Supplement (BSL-B)
Timepoint [2] 331540 0
Baseline, first session of group (waitlist comparison only), after final session of group (primary timepoint), and 6 months post final session of group.
Primary outcome [3] 331541 0
Change in self and other functioning assessed using the Levels of Personality Functioning-Brief Scale (LFPS-BF)
Timepoint [3] 331541 0
Baseline, beginning of first group session (waitlist comparison only), after final session of group (primary timepoint), and 6 months post final session of group.
Secondary outcome [1] 410212 0
Change in difficulties with emotion regulation as assessed by the Difficulties in Emotion Regulation Scale-18 (DERS-18)
Timepoint [1] 410212 0
Baseline, beginning of first group session (waitlist comparison only), after final session of group, 6 months post final session of group.
Secondary outcome [2] 410213 0
Change in service utilisation as indicated by number of emergency department presentations audited from patient electronic medical records.
Timepoint [2] 410213 0
Youth, Adult and Regional Online groups: 6 months prior to the intervention and 6 months after the final group session. Criminal justice group: Changes in emergency department presentations will not be assessed.
Secondary outcome [3] 410215 0
The acceptability of the intervention will be assessed via a single item 'I liked the Road Maps group program' rated on a 5-point likert scale. A mean score between 3.6 and 5 will be considered satisfactory.
Timepoint [3] 410215 0
After the final group session.
Secondary outcome [4] 410611 0
Youth, Adult and Regional Online groups: A change in service utilisation as indicated number of mental health related inpatient admissions audited from patient electronic medical records.
Criminal justice group: Changes in mental health reported admissions will not be audited for this group.
Timepoint [4] 410611 0
6 months before the first group session and 6 months post the final group session
Secondary outcome [5] 410612 0
Youth, Adult and Regional Online groups: A change in service utilisation as indicated number of mental health related inpatient bed days audited from patient electronic medical records.
Criminal justice group: Changes in mental health inpatient bed days will not be audited for this group.
Timepoint [5] 410612 0
6 months before the first group session and 6 months post the final group session
Secondary outcome [6] 410613 0
The appropriateness of the intervention will be assessed via a single item 'The group was a good match for me' rated on a 5-point likert scale. A mean score between 3.6 and 5 will be considered satisfactory.
Timepoint [6] 410613 0
After the final group session
Secondary outcome [7] 410614 0
The subject use of the intervention as evaluated by the single item 'The group was useful and sensible' rated on a 5 point Likert scale. A mean score between 3.6 and 5 will be considered satisfactory.
Timepoint [7] 410614 0
At the end of the final group session
Secondary outcome [8] 410615 0
Differences in engaged (describes the positive working group atmosphere) as measured by the Group Climate Questionnaire (GCQ)
Timepoint [8] 410615 0
At the end of the final group session
Secondary outcome [9] 410616 0
Differences in conflict (defined as anger and tension in the group) as measured by the Group Climate Questionnaire (GCQ)
Timepoint [9] 410616 0
After final group session
Secondary outcome [10] 410617 0
Differences in Avoiding (describes behaviours indicating avoidance of personal responsibility of the group work by the members)
Timepoint [10] 410617 0
After the final group session
Secondary outcome [11] 410619 0
Feasibility of the program based proportion of participants who dropped out of the study (completed less than 60%) as audited from attendance records.
Timepoint [11] 410619 0
After the final group session
Secondary outcome [12] 410623 0
Engagement with mental health related support with a general practitioner (GP) assessed by self-reported frequency of visits in the past 4 weeks and 6 months.
Timepoint [12] 410623 0
Assessed 6 months after the final group session
Secondary outcome [13] 410624 0
Engagement with mental health related support with a public sector mental/community mental health services assessed by self-reported frequency of visits in the past 4 weeks and 6 months.
Timepoint [13] 410624 0
6 months after the final group session
Secondary outcome [14] 410625 0
Engagement with mental health related support with a private practitioner (e.g. psychologist, psychiatrist, counsellor) assessed by self-reported frequency of visits in the past 4 weeks and 6 months.
Timepoint [14] 410625 0
6 months after final group session
Secondary outcome [15] 410626 0
Engagement with mental health related support from a Non-government organisation or primary health network service assessed by self-reported frequency of visits in the past 4 weeks and 6 months.
Timepoint [15] 410626 0
6 months after the last group session
Secondary outcome [16] 410627 0
Psychosocial functioning assessed via self-report of number of days the person was unable to work, study or manage day-to-day activities in the last 4 weeks
Timepoint [16] 410627 0
6 months after final group session
Secondary outcome [17] 410628 0
Psychosocial functioning as assessed by self-reported number of days the person had to CUT DOWN what they did because of how they were feeling.
Timepoint [17] 410628 0
6 months after the final group session
Secondary outcome [18] 410630 0
Changes in hypomentalizing as measured by the Reflective Functioning Questionnaire (RFQ-8)
Timepoint [18] 410630 0
Baseline, beginning of first group session (waitlist condition), after final session of group and 6 months after the final group session.
Secondary outcome [19] 410632 0
Changes in hypermentalizing as measured by the reflective functioning questionnaire (RFQ-8)
Timepoint [19] 410632 0
Baseline, beginning of first group session (waitlist condition), after final session of group and 6 months after the final group session.
Secondary outcome [20] 425559 0
Criminal Justice group only: Changes in negative affectivity as measured by the Personality Inventory for DSM 5 Brief Form (PID-5-BF).
Timepoint [20] 425559 0
Measured at baseline, beginning of the first group session (waitlist condition) after final session of group and 6 months after the final group session.
Secondary outcome [21] 425560 0
Criminal justice only - Changes in antagonism as measured by the Personality Inventory for DSM 5 Brief Form (PID-5-BF).
Timepoint [21] 425560 0
Measured at baseline, beginning of the first group session (waitlist condition) after final session of group and 6 months after the final group session.


Secondary outcome [22] 425561 0
Criminal justice only - Changes in psychoticism as measured by the Personality Inventory for DSM 5 Brief Form (PID-5-BF).
Timepoint [22] 425561 0
Measured at baseline, beginning of the first group session (waitlist condition) after final session of group and 6 months after the final group session.

Secondary outcome [23] 425562 0
Criminal justice only - Changes in disinhibition as measured by the Personality Inventory for DSM 5 Brief Form (PID-5-BF).
Timepoint [23] 425562 0
Measured at baseline, beginning of the first group session (waitlist condition) after final session of group and 6 months after the final group session.
Secondary outcome [24] 425563 0
Criminal justice only - Changes in detachment as measured by the Personality Inventory for DSM 5 Brief Form (PID-5-BF).
Timepoint [24] 425563 0
Measured at baseline, beginning of the first group session (waitlist condition) after final session of group and 6 months after the final group session.
Secondary outcome [25] 425564 0
Changes in psychosocial functioning as measured by the Work and Social Adjustment Scale (WSAS). . This is assessed for all groups excluding the criminal justice group.
Timepoint [25] 425564 0
Measured at baseline, beginning of the first group session (waitlist condition) after final session of group and 6 months after the final group session

Eligibility
Key inclusion criteria
Road Maps Intervention:
1. Resides in South Australia
2. Meets criteria for a diagnosis of BPD and/or clinically significant borderline symptoms
3. Aged 16 years and older
4. Willing and able to provide informed consent

The person may be eligible for the criminal justice group if they also meet the following criteria:
• Are currently being supervised by or have contact with the Department for Correctional Services (e.g., on supervised bail, parole, home detention);
• Have a pending/outstanding South Australian court matter (i.e., a charge that is currently before the courts and has not yet been finalised);
• Have had a charge or sentence that occurred/concluded within the last 2 years.

Carer Session:
1. Participants for the carer session are nominated by the Road Map participants.
2. The term 'carer' is considered broadly and may include family members, friends and significant others.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Road Maps Intervention - adult, youth, regional:
- None

Criminal justice population:
- Demonstrates behaviours or personality features that may be disruptive or unsafe in the group environment;
- Unwilling/involuntary participation;
- Lacks sufficient basic literacy or English language skills.


Carer Session:
- Clinicians/employed carers.

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
Other
Other design features
To test whether the intervention is more effective than waitlist condition, the adult, youth and criminal justice groups will compare outcomes between a naturalistic waitlist condition (i.e. consumers assessed greater than 4 weeks before the first group session will be asked to complete an additional assessment at the end of the waitlist period) to an intervention group. All participants will receive the intervention.

The length of the youth version differs from the adult (e.g. 10 compared to 12 weeks). However, comparisons are not made between these two populations.

The outcomes from the online group delivered to regional consumers will be compared to a sample those who completed Road Maps face-to-face within a metropolitan setting.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive data will be reported for the post-group assessment of group appropriateness, acceptability and subjective use. To test the effectiveness of the intervention compared to waitlist control, multilevel mixed modelling will be utilized using ‘MIXED’ procedure in SPSS 27. Statistical analyses will be based on the ITT sample with an alpha level p<.05. Separate analyses were run for each of the primary and secondary variables. First, we will the effect of condition (waitlist/intervention) as a fixed factor on outcome. Second, we included the baseline score (group centered mean) as a covariate in the model. Finally, to account for the hierarchical structure of the data we included group as a random intercept to see if this improved the fit of the model.
Multilevel mixed modelling (MLM) will also be utilised to explore a change in participants scores on each of the measures between baseline, after the final group session and 6 months after the final group session. Changes in service utilization (count data) will be explored using mixed-effects negative binomial regression.

Finally, we will describe what therapeutic supports participants are engaged with 6 months post-the final group session. In line with the philosophy of the stepped model of care, we expect symptom and psychosocial improvement to be associated with engagement with other therapeutic and psychosocial supports over the follow up period.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/06/2020
Date of last participant enrolment
Anticipated
29/12/2023
Actual
Date of last data collection
Anticipated
13/05/2024
Actual
Sample size
Target
320
Accrual to date
293
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 311555 0
Government body
Name [1] 311555 0
Borderline Personality Disorder Collaborative
Country [1] 311555 0
Australia
Primary sponsor type
Government body
Name
Borderline Personality Disorder Collaborative
Address
1/100 Greenhill Road, Unley SA 5061
Country
Australia
Secondary sponsor category [1] 312970 0
None
Name [1] 312970 0
Address [1] 312970 0
Country [1] 312970 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311005 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 311005 0
Flinders Medical Centre
Ward 6C, Room 6A219
Flinders Drive, Bedford Park SA 5042
Ethics committee country [1] 311005 0
Australia
Date submitted for ethics approval [1] 311005 0
Approval date [1] 311005 0
13/05/2020
Ethics approval number [1] 311005 0
HREC/20/SAC/92

Summary
Brief summary
Borderline Personality Disorder (BPD) is a common, yet complex, mental illness. People with a diagnosis of BPD experience significant distress due to difficulties relating to other people and the world around them, disruptions to family, social and work life. Symptoms of BPD may include difficulty regulating emotions, impulsive behaviours, self-harm, suicidal ideation/ attempts, feelings of detachment from their own experiences, and/or intense and unstable relationships. Although BPD is a long-term condition with high rates of relapse and crisis, recovery is possible with suitable therapy. Treatment approaches for people living with BPD are often intensive and lengthy, which can mean long waiting periods for patients to enter programs. Additionally, a lengthy treatment period may not be suitable for all individuals with BPD seeking treatment. Borderline Personality Disorder Collaborative (BPD Co) has developed a short term group therapy program (Road Maps) informed by common factors across evidence-based approaches to assist South Australians living with BPD to achieve optimal quality of life and experience recovery.

Road Maps aims to help people living with BPD understand and connect their emotional, cognitive and behavioural experiences. The Road Maps Pilot Study will assess the feasibility and appropriateness of the Road Maps program. Furthermore, the effectiveness of the program will be assessed by comparing the severity of psychological symptoms before and after attendance to the program. Additionally, the impact of the program on participant use of other health services such as mental health services and emergency department (ED) presentations will be assessed. The investigators hypothesise that participants in the intervention group will report a significantly greater reduction in borderline symptom severity, impulsive and self-destructive behaviour, psychosocial distress, self and interpersonal dysfunction compared to the group on the waitlist. It is also anticipated that therapeutic gains will be maintained 6 months post-intervention, with an expectation that this will be associated with linkage to ongoing therapeutic supports over this time period in line with the philosophy of the stepped care model.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119666 0
Dr Dianna Bartsch
Address 119666 0
Borderline Personality Disorder Collaborative (BPD Co)
1/100 Greenhill Road
Unley 5061
South Australia
Country 119666 0
Australia
Phone 119666 0
+61874256500
Fax 119666 0
Email 119666 0
dianna.bartsch@sa.gov.au
Contact person for public queries
Name 119667 0
Dr Dianna Bartsch
Address 119667 0
Borderline Personality Disorder Collaborative (BPD Co)
1/100 Greenhill Road
Unley 5061
South Australia
Country 119667 0
Australia
Phone 119667 0
+610874256500
Fax 119667 0
Email 119667 0
dianna.bartsch@sa.gov.au
Contact person for scientific queries
Name 119668 0
Dr Dianna Bartsch
Address 119668 0
Borderline Personality Disorder Collaborative (BPD Co)
1/100 Greenhill Road
Unley 5061
South Australia
Country 119668 0
Australia
Phone 119668 0
+610874256500
Fax 119668 0
Email 119668 0
dianna.bartsch@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.