The BRIDGE Project

Study Overview
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Brief Summary
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Borderline Personality Disorder (BPD) is characterised by long standing difficulty in managing emotional responses, personal relationships, impulse control and self-image. Many adolescents and young people with complex needs and high suicide risk are left under-diagnosed and untreated. The overall aim of the study is to assess the possibility of providing a treatment programme for young people with BPD symptoms in the general population, who may or may not be accessing any mental health services.

Detailed Description
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This project is the first step in testing a new intervention programme, called BRIDGE (Brief, Intensive Assessment and Integrated Formulation), for young people early in the course of Borderline Personality Disorder (BPD). The BRIDGE Project will help the investigators find out whether they can do a much bigger study in the future that will tell them whether BRIDGE works well. BPD is characterised by long standing difficulty in managing emotional responses, personal relationships, impulse control and self-image. Research shows that individuals with BPD may experience discrimination and resulting stigmatisation by both the public and health care professionals. Many adolescents and young people with complex needs and high suicide risk are left under-diagnosed and untreated. As a result, young people with BPD are frequently not in education or training and experience challenging relationships with friends and families. The overall aim of the study is to assess the possibility of providing a treatment programme for young people with BPD symptoms in the general population, who may or may not be accessing any mental health services. First, the investigators need to see whether young people are comfortable with random allocation to BRIDGE (AND service as usual) or Service-as-usual (ALONE) (a bit like tossing a coin). Second, the investigators need to find out whether enough young people want to be involved. Third, whether the investigators can find out the information they need about them and can follow up enough young people later. The proposed study will try to find these things out, so that the investigators can design a future, bigger, study to find out whether BRIDGE is good value for young people with BPD.

Official Title
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The BRIDGE Project: A Feasibility Randomised Controlled Trial of Brief, Intensive Assessment and Integrated Formulation for Young People (Age 14-24) Early in the Course of Borderline Personality Disorder

Conditions
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Borderline Personality Disorder

Intervention / Treatment
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* Behavioral: BRIDGE Intervention
* Behavioral: Service as Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cut off score of 11 out of 15 on the self-reported SCID-II BPD questionnaire AND subthreshold (3 or 4 out of 9 domains) or threshold (5 and above out of 9 domains) criteria on the SCID-II DSM-V (BPD Module) Age 14-25 Exclusion Criteria: Currently receiving psychological/counselling /psychotherapeutic treatment for BPD Has received psychological/counselling/psychotherapeutic intervention for over 8 sessions in the last 3 months Severe or profound intellectual disability, that would preclude full engagement in talking therapy Receiving Intensive psychiatric treatment at the time of study entry, for conditions such as acute psychosis or severe eating disorder Non-English speaking

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BRIDGE Intervention (+Service as Usual)<br>The brief, intensive assessment and integrated formulation (BRIDGE) intervention is delivered over 3-6 months and has a three-fold focus: Firstly, an intensive (post-randomisation) assessment, taking up to two sessions, including BPD symptoms, co-presenting difficulties, neurodevelopmental profile, life events history and psychosocial functional impact. Secondly, up to 16 sessions of Cognitive Analytic Therapy (CAT). Thirdly, development of a shared formulation with a multi-agency group; further development of the shared formulation with the young person, using CAT principles (Reformulation, Recognition and Revision) and, where clinically applicable, their family and service-providers. | Behavioral: BRIDGE Intervention<br>* Intensive clinical assessment; >16 sessions of Cognitive Analytic Therapy (CAT); Development of a shared formulation<br>Behavioral: Service as Usual<br>* Likely to range from social services, mental-health services, forensic services to no intervention<br>|
| Active Comparator: Service as Usual<br>For participants randomised to Service-As-Usual (SAU), a routine letter of their participation will be shared with their service provider(s), including the GP. SAU, likely to range from social services, mentalhealth services, forensic services to no intervention will be mapped and described for each participant. Treatment fidelity to SAU will therefore not be assessed, but the nature and intensity of SAU in different contexts will be described in detail through the qualitative process evaluation. | Behavioral: Service as Usual<br>* Likely to range from social services, mental-health services, forensic services to no intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment & Retention rates | The number of participants recruited for randomisation and the number retained to follow-up (12 & 24wks post randomisation). | Continuous over 3 year study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of trial processes and interventions | Explored through qualitative interviews | Continuous over 3 year study period | 
| Process Evaluation | Theory of change and logic modelling will be explored to capture the process behind intervention effects. | Continuous over 3 year study period |