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The BRIDGE Project (BRIDGE)

Primary Purpose

Borderline Personality Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
BRIDGE Intervention
Service as Usual
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Borderline Personality Disorder

Eligibility Criteria

14 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NHS Greater Glasgow and Clyde Clinical Research and Development Central OfficeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BRIDGE Intervention (+Service as Usual)

Service as Usual

Arm Description

The brief, intensive assessment and integrated formulation (BRIDGE) intervention is delivered over 3-6 months and has a three-fold focus: Firstly, an intensive (post-randomisation) assessment, taking up to two sessions, including BPD symptoms, co-presenting difficulties, neurodevelopmental profile, life events history and psychosocial functional impact. Secondly, up to 16 sessions of Cognitive Analytic Therapy (CAT). Thirdly, development of a shared formulation with a multi-agency group; further development of the shared formulation with the young person, using CAT principles (Reformulation, Recognition and Revision) and, where clinically applicable, their family and service-providers.

For participants randomised to Service-As-Usual (SAU), a routine letter of their participation will be shared with their service provider(s), including the GP. SAU, likely to range from social services, mentalhealth services, forensic services to no intervention 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.

Outcomes

Primary Outcome Measures

Recruitment & Retention rates
The number of participants recruited for randomisation and the number retained to follow-up (12 & 24wks post randomisation).

Secondary Outcome Measures

Acceptability of trial processes and interventions
Explored through qualitative interviews
Process Evaluation
Theory of change and logic modelling will be explored to capture the process behind intervention effects.

Full Information

First Posted
July 9, 2021
Last Updated
February 24, 2022
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT05023447
Brief Title
The BRIDGE Project
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Borderline Personality Disorder (BPD) is characterised by long standing difficulty in managing emotional responses, personal relationships, impulse control and self-image. Many adolescents and young people with complex needs and high suicide risk are left under-diagnosed and untreated. 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.
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 the investigators find out whether they can do a much bigger study in the future that will tell them 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, the investigators 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, the investigators need to find out whether enough young people want to be involved. Third, whether the investigators can find out the information they need about them and can follow up enough young people later. The proposed study will try to find these things out, so that the investigators can design a future, bigger, study to find out whether BRIDGE is good value for young people with BPD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Randomized
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BRIDGE Intervention (+Service as Usual)
Arm Type
Experimental
Arm Description
The brief, intensive assessment and integrated formulation (BRIDGE) intervention is delivered over 3-6 months and has a three-fold focus: Firstly, an intensive (post-randomisation) assessment, taking up to two sessions, including BPD symptoms, co-presenting difficulties, neurodevelopmental profile, life events history and psychosocial functional impact. Secondly, up to 16 sessions of Cognitive Analytic Therapy (CAT). Thirdly, development of a shared formulation with a multi-agency group; further development of the shared formulation with the young person, using CAT principles (Reformulation, Recognition and Revision) and, where clinically applicable, their family and service-providers.
Arm Title
Service as Usual
Arm Type
Active Comparator
Arm Description
For participants randomised to Service-As-Usual (SAU), a routine letter of their participation will be shared with their service provider(s), including the GP. SAU, likely to range from social services, mentalhealth services, forensic services to no intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
BRIDGE Intervention
Intervention Description
Intensive clinical assessment; >16 sessions of Cognitive Analytic Therapy (CAT); Development of a shared formulation
Intervention Type
Behavioral
Intervention Name(s)
Service as Usual
Intervention Description
Likely to range from social services, mental-health services, forensic services to no intervention
Primary Outcome Measure Information:
Title
Recruitment & Retention rates
Description
The number of participants recruited for randomisation and the number retained to follow-up (12 & 24wks post randomisation).
Time Frame
Continuous over 3 year study period
Secondary Outcome Measure Information:
Title
Acceptability of trial processes and interventions
Description
Explored through qualitative interviews
Time Frame
Continuous over 3 year study period
Title
Process Evaluation
Description
Theory of change and logic modelling will be explored to capture the process behind intervention effects.
Time Frame
Continuous over 3 year study period
Other Pre-specified Outcome Measures:
Title
Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II) PQ-BPD
Description
15 Item Questionnaire for Borderline Personality Disorder
Time Frame
Screening; Pre-randomisation
Title
Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II) DSM-V
Description
Clinical interview using the SCID-II DSM-V
Time Frame
Screening/Pre-randomisation
Title
KIDSCREEN-10 Index
Description
Health Questionnaire for Children and Young People
Time Frame
Screening/Pre-randomisation
Title
KIDDIE Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL)
Description
Questionnaire for affective disorders and schizophrenia
Time Frame
within 2 weeks of randomisation (baseline)
Title
Adverse Childhood Experiences Scale
Description
Questionnaire for Adverse Childhood Experiences
Time Frame
within 2 weeks of randomisation (baseline)
Title
The Autism Symptom Self Report for Adolescents (ASSERT) Scale
Description
Questionnaire for symptoms of Autism
Time Frame
within 2 weeks of randomisation (baseline)
Title
Adult ADHD Self-Report Scale (ASRS)
Description
Questionnaire for ADHD symptoms in adulthood
Time Frame
within 2 weeks of randomisation (baseline)
Title
Borderline Symptoms List (BSL)
Description
Questionnaire for symptoms of Borderline Personality Disorder (BPD)
Time Frame
Baseline and Follow-up (12 and 24weeks post randomisation)
Title
Sheehan's Disability Scale (SDS)
Description
Assessment of functional impairment
Time Frame
Baseline and Follow-up (12 and 24weeks post randomisation)
Title
Barratt Impulsiveness Scale (BIS-Brief)
Description
Questionnaire to assess impulsivity
Time Frame
Baseline and Follow-up (12 and 24weeks post randomisation)
Title
Difficulties in Emotional Regulation Scale-Short Form (DERS-SF)
Description
Questionnaire to assess emotion regulation
Time Frame
Baseline and Follow-up (12 and 24weeks post randomisation)
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
General health questionnaire
Time Frame
Baseline and Follow-up (12 and 24weeks post randomisation)
Title
EuroQol-5D-5L (EQ-5D-5L)
Description
Quality of Life questionnaire
Time Frame
Baseline and Follow-up (12 and 24weeks post randomisation)
Title
Suicidal Ideation Scale
Description
Questionnaire for suicidal ideation
Time Frame
Baseline and Follow-up (12 and 24weeks post randomisation)
Title
Vocational and Educational Functioning
Description
Measure of functioning in domains of work and education
Time Frame
Baseline and Follow-up (12 and 24weeks post randomisation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruchika Gajwani, Dr
Phone
01412010233
Email
Ruchika.Gajwani@glasgow.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruchika Gajwani, Dr
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
NHS Greater Glasgow and Clyde Clinical Research and Development Central Office
City
Paisley
ZIP/Postal Code
PA2 7DE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma McDonough
Email
Emma.McDonough@ggc.scot.nhs.uk
First Name & Middle Initial & Last Name & Degree
Lona Jawaheer, MBChB
Email
lonajawaheer@nhs.net
First Name & Middle Initial & Last Name & Degree
David Yorston, MBChB
First Name & Middle Initial & Last Name & Degree
Lona Jawaheer, MBChB
First Name & Middle Initial & Last Name & Degree
Gerard McGowan, MBChB

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

The BRIDGE Project

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