Clinical trial NCT05023447: The BRIDGE Project
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Borderline Personality Disorder
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2021-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment & Retention rates
timeFrame: Continuous over 3 year study period
Secondary outcomes:
measure: Acceptability of trial processes and interventions
timeFrame: Continuous over 3 year study period
measure: Process Evaluation
timeFrame: Continuous over 3 year study period
Other outcomes:
measure: Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II) PQ-BPD
timeFrame: Screening; Pre-randomisation
measure: Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II) DSM-V
timeFrame: Screening/Pre-randomisation
measure: KIDSCREEN-10 Index
timeFrame: Screening/Pre-randomisation
measure: KIDDIE Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL)
timeFrame: within 2 weeks of randomisation (baseline)
measure: Adverse Childhood Experiences Scale
timeFrame: within 2 weeks of randomisation (baseline)
measure: The Autism Symptom Self Report for Adolescents (ASSERT) Scale
timeFrame: within 2 weeks of randomisation (baseline)
measure: Adult ADHD Self-Report Scale (ASRS)
timeFrame: within 2 weeks of randomisation (baseline)
measure: Borderline Symptoms List (BSL)
timeFrame: Baseline and Follow-up (12 and 24weeks post randomisation)
measure: Sheehan's Disability Scale (SDS)
timeFrame: Baseline and Follow-up (12 and 24weeks post randomisation)
measure: Difficulties in Emotional Regulation Scale-Short Form (DERS-SF)
timeFrame: Baseline and Follow-up (12 and 24weeks post randomisation)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline and Follow-up (12 and 24weeks post randomisation)
measure: EuroQol-5D-5L (EQ-5D-5L)
timeFrame: Baseline and Follow-up (12 and 24weeks post randomisation)
measure: Suicidal Ideation Scale
timeFrame: Baseline and Follow-up (12 and 24weeks post randomisation)
measure: Vocational and Educational Functioning
timeFrame: Baseline and Follow-up (12 and 24weeks post randomisation)
Locations:
city: Paisley
country: United Kingdom
facility: NHS Greater Glasgow and Clyde Clinical Research and Development Central Office
Study officials:
affiliation: University of Glasgow
name: Ruchika Gajwani, Dr
role: PRINCIPAL_INVESTIGATOR
References: