The BRIDGE Project

Borderline Personality Disorder Clinical Trial

— BRIDGE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05023447
• Other study ID #: GN21MH147
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Behavioral:
• BRIDGE Intervention
Intensive clinical assessment; >16 sessions of Cognitive Analytic Therapy (CAT); Development of a shared formulation
• Service as Usual
Likely to range from social services, mental-health services, forensic services to no intervention

Locations

Country	Name	City	State
United Kingdom	NHS Greater Glasgow and Clyde Clinical Research and Development Central Office	Paisley

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II) PQ-BPD	15 Item Questionnaire for Borderline Personality Disorder	Screening; Pre-randomisation
Other	Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II) DSM-V	Clinical interview using the SCID-II DSM-V	Screening/Pre-randomisation
Other	KIDSCREEN-10 Index	Health Questionnaire for Children and Young People	Screening/Pre-randomisation
Other	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)
Other	Adverse Childhood Experiences Scale	Questionnaire for Adverse Childhood Experiences	within 2 weeks of randomisation (baseline)
Other	The Autism Symptom Self Report for Adolescents (ASSERT) Scale	Questionnaire for symptoms of Autism	within 2 weeks of randomisation (baseline)
Other	Adult ADHD Self-Report Scale (ASRS)	Questionnaire for ADHD symptoms in adulthood	within 2 weeks of randomisation (baseline)
Other	Borderline Symptoms List (BSL)	Questionnaire for symptoms of Borderline Personality Disorder (BPD)	Baseline and Follow-up (12 and 24weeks post randomisation)
Other	Sheehan's Disability Scale (SDS)	Assessment of functional impairment	Baseline and Follow-up (12 and 24weeks post randomisation)
Other	Difficulties in Emotional Regulation Scale-Short Form (DERS-SF)	Questionnaire to assess emotion regulation	Baseline and Follow-up (12 and 24weeks post randomisation)
Other	Patient Health Questionnaire-9 (PHQ-9)	General health questionnaire	Baseline and Follow-up (12 and 24weeks post randomisation)
Other	EuroQol-5D-5L (EQ-5D-5L)	Quality of Life questionnaire	Baseline and Follow-up (12 and 24weeks post randomisation)
Other	Suicidal Ideation Scale	Questionnaire for suicidal ideation	Baseline and Follow-up (12 and 24weeks post randomisation)
Other	Vocational and Educational Functioning	Measure of functioning in domains of work and education	Baseline and Follow-up (12 and 24weeks post randomisation)
Primary	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	Acceptability of trial processes and interventions	Explored through qualitative interviews	Continuous over 3 year study period
Secondary	Process Evaluation	Theory of change and logic modelling will be explored to capture the process behind intervention effects.	Continuous over 3 year study period