The BRIDGE Project (BRIDGE)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Borderline Personality Disorder
• Intervention / Treatment: Behavioral: BRIDGE Intervention; Behavioral: Service as Usual

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Paisley, United Kingdom, PA2 7DE
    • NHS Greater Glasgow and Clyde Clinical Research and Development Central Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BRIDGE Intervention (+Service as Usual); 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.	Behavioral: BRIDGE Intervention; Intensive clinical assessment; >16 sessions of Cognitive Analytic Therapy (CAT); Development of a shared formulation; Behavioral: Service as Usual; Likely to range from social services, mental-health services, forensic services to no intervention
Active Comparator: Service as Usual; 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.	Behavioral: Service as Usual; Likely to range from social services, mental-health services, forensic services to no intervention

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: University of Glasgow
• Investigators: Principal Investigator: Ruchika Gajwani, Dr, University of Glasgow

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder
• Other Study ID Numbers: GN21MH147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No