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| Name | Class |
|---|---|
| University of Glasgow | OTHER |
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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.
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 us find out whether we can do a much bigger study in the future that will tell us 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, we 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, we need to find out whether enough young people want to be involved. Third, whether we can find out the information we need about them and can follow up enough young people later. The proposed study will try to find these things out, so that we can design a future, bigger, study to find out whether BRIDGE is good value for young people with BPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BRIDGE Intervention (+Service as Usual) | Experimental | Brief, intensive assessment and integrated formulation (BRIDGE) intervention is guided by the evidence base of Cognitive Analytic Therapy (CAT) with young people (aged 14-25) with features of BPD using an early intervention model and in collaboration with an established Glasgow programme, Intensive Support and Monitoring Service (ISMS). ISMS focuses on reaching a shared formulation with the young person and the multi-agency system that supports them. BRIDGE is delivered over 3-6 months and includes :- an intensive assessment, including BPD symptoms, copresenting difficulties, neurodevelopmental profile, life events history and psychosocial functioning; up to 16 sessions of Cognitive Analytic Therapy (CAT) and the development of a shared formulation with a multi-agency group. Further development of this formulation with the young person, using CAT principles (Reformulation, Recognition and Revision) and, where clinically applicable, their family and service-providers. |
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| Service as Usual | Active Comparator | Services as Usual (SAU) For participants randomised to SAU, a routine letter of their participation will be shared with their service provider(s), including their GP. SAU, is likely to range from social services, mental-health services, forensic services to no services in some cases. Pathways to care and service involvement 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRIDGE Intervention | Behavioral | Intensive clinical assessment; >16 sessions of Cognitive Analytic Therapy (CAT); Development of a shared formulation |
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| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II) PQ-BPD | 15 Item Questionnaire for Borderline Personality Disorder | Screening; Pre-randomisation |
| Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II) DSM-V |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruchika Gajwani, Dr | University of Glasgow | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHS Greater Glasgow and Clyde Clinical Research and Development Central Office | Paisley | PA2 7DE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39381608 | Derived | Gajwani R, Sim F, McAllister K, Smith H, McIntosh E, Moran P, Ougrin D, Smith M, Gumley AI, Chanen AM, Minnis H. The BRIDGE project: a feasibility randomised controlled trial of brief, intensive assessment and integrated formulation for young people (age 14-24) with features of borderline personality disorder (Protocol). Front Psychiatry. 2024 Sep 24;15:1389578. doi: 10.3389/fpsyt.2024.1389578. eCollection 2024. |
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The PI will manage access rights to the data set. We anticipate that anonymised trial data may be shared with other researchers to contribute to the emerging BPD evidence base.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2023 | Nov 28, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
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Randomized
| Service as Usual | Behavioral | Likely to range from social services, mental-health services, forensic services to no intervention |
|
| Continuous over 3 year study period |
Clinical interview using the SCID-II DSM-V
| Screening/Pre-randomisation |
| KIDSCREEN-10 Index | Health Questionnaire for Children and Young People | Screening/Pre-randomisation |
| KIDDIE Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL) | Questionnaire for affective disorders and schizophrenia | within 2 weeks of randomisation (baseline) |
| Adverse Childhood Experiences Scale | Questionnaire for Adverse Childhood Experiences | within 2 weeks of randomisation (baseline) |
| The Autism Symptom Self Report for Adolescents (ASSERT) Scale | Questionnaire for symptoms of Autism | within 2 weeks of randomisation (baseline) |
| Adult ADHD Self-Report Scale (ASRS) | Questionnaire for ADHD symptoms in adulthood | within 2 weeks of randomisation (baseline) |
| Borderline Symptoms List (BSL) | Questionnaire for symptoms of Borderline Personality Disorder (BPD) | Baseline and Follow-up (12 and 24weeks post randomisation) |
| Sheehan's Disability Scale (SDS) | Assessment of functional impairment | Baseline and Follow-up (12 and 24weeks post randomisation) |
| Difficulties in Emotional Regulation Scale-Short Form (DERS-SF) | Questionnaire to assess emotion regulation | Baseline and Follow-up (12 and 24weeks post randomisation) |
| Patient Health Questionnaire-9 (PHQ-9) | General health questionnaire | Baseline and Follow-up (12 and 24weeks post randomisation) |
| EuroQol-5D-5L (EQ-5D-5L) | Quality of Life questionnaire | Baseline and Follow-up (12 and 24weeks post randomisation) |
| Suicidal Ideation Scale | Questionnaire for suicidal ideation | Baseline and Follow-up (12 and 24weeks post randomisation) |
| Vocational and Educational Functioning | Measure of functioning in domains of work and education | Baseline and Follow-up (12 and 24weeks post randomisation) |