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The BRIDGE Project

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05023447
Acronym
BRIDGE
Enrollment
60
Registered
2021-08-26
Start date
2021-09-01
Completion date
2024-09-30
Last updated
2024-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline Personality Disorder

Brief 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.

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.

Interventions

Intensive clinical assessment; \>16 sessions of Cognitive Analytic Therapy (CAT); Development of a shared formulation

Likely to range from social services, mental-health services, forensic services to no intervention

Sponsors

University of Glasgow
CollaboratorOTHER
NHS Greater Glasgow and Clyde
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Randomized

Eligibility

Sex/Gender
ALL
Age
14 Years to 24 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recruitment & Retention ratesContinuous over 3 year study periodThe number of participants recruited for randomisation and the number retained to follow-up (12 & 24wks post randomisation).

Secondary

MeasureTime frameDescription
Acceptability of trial processes and interventionsContinuous over 3 year study periodExplored through qualitative interviews
Process EvaluationContinuous over 3 year study periodTheory of change and logic modelling will be explored to capture the process behind intervention effects.

Other

MeasureTime frameDescription
Vocational and Educational FunctioningBaseline and Follow-up (12 and 24weeks post randomisation)Measure of functioning in domains of work and education
Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II) DSM-VScreening/Pre-randomisationClinical interview using the SCID-II DSM-V
KIDSCREEN-10 IndexScreening/Pre-randomisationHealth Questionnaire for Children and Young People
KIDDIE Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL)within 2 weeks of randomisation (baseline)Questionnaire for affective disorders and schizophrenia
Adverse Childhood Experiences Scalewithin 2 weeks of randomisation (baseline)Questionnaire for Adverse Childhood Experiences
EuroQol-5D-5L (EQ-5D-5L)Baseline and Follow-up (12 and 24weeks post randomisation)Quality of Life questionnaire
Adult ADHD Self-Report Scale (ASRS)within 2 weeks of randomisation (baseline)Questionnaire for ADHD symptoms in adulthood
Borderline Symptoms List (BSL)Baseline and Follow-up (12 and 24weeks post randomisation)Questionnaire for symptoms of Borderline Personality Disorder (BPD)
Sheehan's Disability Scale (SDS)Baseline and Follow-up (12 and 24weeks post randomisation)Assessment of functional impairment
Difficulties in Emotional Regulation Scale-Short Form (DERS-SF)Baseline and Follow-up (12 and 24weeks post randomisation)Questionnaire to assess emotion regulation
Patient Health Questionnaire-9 (PHQ-9)Baseline and Follow-up (12 and 24weeks post randomisation)General health questionnaire
The Autism Symptom Self Report for Adolescents (ASSERT) Scalewithin 2 weeks of randomisation (baseline)Questionnaire for symptoms of Autism
Suicidal Ideation ScaleBaseline and Follow-up (12 and 24weeks post randomisation)Questionnaire for suicidal ideation
Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II) PQ-BPDScreening; Pre-randomisation15 Item Questionnaire for Borderline Personality Disorder

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026