ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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

ACTRN12622000849796

Ethics application status

Approved

Date submitted

31/05/2022

Date registered

16/06/2022

Date last updated

4/08/2024

Date data sharing statement initially provided

16/06/2022

Date results provided

30/07/2024

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Borderline Personality Disorder

Condition category

Condition code

Mental Health

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]

Behaviour

Intervention code [2]

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]

Change in borderline symptom severity assessed using the Borderline Symptom List - 23 (BSL-23)

Timepoint [1]

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]

Change in impulsive and self-destructive behaviour assessed using the Borderline Symptom List Behavioural Supplement (BSL-B)

Timepoint [2]

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]

Change in self and other functioning assessed using the Levels of Personality Functioning-Brief Scale (LFPS-BF)

Timepoint [3]

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]

Change in difficulties with emotion regulation as assessed by the Difficulties in Emotion Regulation Scale-18 (DERS-18)

Timepoint [1]

Baseline, beginning of first group session (waitlist comparison only), after final session of group, 6 months post final session of group.

Secondary outcome [2]

Change in service utilisation as indicated by number of emergency department presentations audited from patient electronic medical records.

Timepoint [2]

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]

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]

After the final group session.

Secondary outcome [4]

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]

6 months before the first group session and 6 months post the final group session

Secondary outcome [5]

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]

6 months before the first group session and 6 months post the final group session

Secondary outcome [6]

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]

After the final group session

Secondary outcome [7]

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]

At the end of the final group session

Secondary outcome [8]

Differences in engaged (describes the positive working group atmosphere) as measured by the Group Climate Questionnaire (GCQ)

Timepoint [8]

At the end of the final group session

Secondary outcome [9]

Differences in conflict (defined as anger and tension in the group) as measured by the Group Climate Questionnaire (GCQ)

Timepoint [9]

After final group session

Secondary outcome [10]

Differences in Avoiding (describes behaviours indicating avoidance of personal responsibility of the group work by the members)

Timepoint [10]

After the final group session

Secondary outcome [11]

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]

After the final group session

Secondary outcome [12]

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]

Assessed 6 months after the final group session

Secondary outcome [13]

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]

6 months after the final group session

Secondary outcome [14]

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]

6 months after final group session

Secondary outcome [15]

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]

6 months after the last group session

Secondary outcome [16]

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]

6 months after final group session

Secondary outcome [17]

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]

6 months after the final group session

Secondary outcome [18]

Changes in hypomentalizing as measured by the Reflective Functioning Questionnaire (RFQ-8)

Timepoint [18]

Baseline, beginning of first group session (waitlist condition), after final session of group and 6 months after the final group session.

Secondary outcome [19]

Changes in hypermentalizing as measured by the reflective functioning questionnaire (RFQ-8)

Timepoint [19]

Baseline, beginning of first group session (waitlist condition), after final session of group and 6 months after the final group session.

Secondary outcome [20]

Criminal Justice group only: Changes in negative affectivity as measured by the Personality Inventory for DSM 5 Brief Form (PID-5-BF).

Timepoint [20]