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Status unknownNCT05023447BRIDGEUpdated Apr 26, 2024

The BRIDGE Project

An interventional study of BRIDGE Intervention and Service as Usual in Borderline Personality Disorder, sponsored by NHS Greater Glasgow and Clyde. Status unknown at 1 site in United Kingdom. Open to participants aged 14 Years to 24 Years. Per ClinicalTrials.gov, last updated 2024-04-26.

Sponsored by NHS Greater Glasgow and Clyde · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
14 Years to 24 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Borderline Personality Disorder
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In context

Borderline Personality Disorder

277 studies on the registry are indexed under Borderline Personality Disorder; 68 are open to participants now.

This study's planned enrollment of 60 is below the median of 70 across 222 interventional studies indexed under Borderline Personality Disorder.

Browse Borderline Personality Disorder studies →

Lead sponsor

NHS Greater Glasgow and Clyde is the lead sponsor of 220 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • 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 · Behavioral: Service as Usual

  • 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

Interventions

  • BehavioralBRIDGE Intervention

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

  • BehavioralService as Usual

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

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What researchers measure

Primary outcomes

  1. Recruitment & Retention rates

    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 outcomes

  1. Acceptability of trial processes and interventions

    Explored through qualitative interviews

    Time frame: Continuous over 3 year study period

  2. Process Evaluation

    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 outcomes

  1. Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II) PQ-BPD

    15 Item Questionnaire for Borderline Personality Disorder

    Time frame: Screening; Pre-randomisation

  2. Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II) DSM-V

    Clinical interview using the SCID-II DSM-V

    Time frame: Screening/Pre-randomisation

  3. KIDSCREEN-10 Index

    Health Questionnaire for Children and Young People

    Time frame: Screening/Pre-randomisation

  4. KIDDIE Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL)

    Questionnaire for affective disorders and schizophrenia

    Time frame: within 2 weeks of randomisation (baseline)

  5. Adverse Childhood Experiences Scale

    Questionnaire for Adverse Childhood Experiences

    Time frame: within 2 weeks of randomisation (baseline)

  6. The Autism Symptom Self Report for Adolescents (ASSERT) Scale

    Questionnaire for symptoms of Autism

    Time frame: within 2 weeks of randomisation (baseline)

  7. Adult ADHD Self-Report Scale (ASRS)

    Questionnaire for ADHD symptoms in adulthood

    Time frame: within 2 weeks of randomisation (baseline)

  8. Borderline Symptoms List (BSL)

    Questionnaire for symptoms of Borderline Personality Disorder (BPD)

    Time frame: Baseline and Follow-up (12 and 24weeks post randomisation)

  9. Sheehan's Disability Scale (SDS)

    Assessment of functional impairment

    Time frame: Baseline and Follow-up (12 and 24weeks post randomisation)

  10. Difficulties in Emotional Regulation Scale-Short Form (DERS-SF)

    Questionnaire to assess emotion regulation

    Time frame: Baseline and Follow-up (12 and 24weeks post randomisation)

  11. Patient Health Questionnaire-9 (PHQ-9)

    General health questionnaire

    Time frame: Baseline and Follow-up (12 and 24weeks post randomisation)

  12. EuroQol-5D-5L (EQ-5D-5L)

    Quality of Life questionnaire

    Time frame: Baseline and Follow-up (12 and 24weeks post randomisation)

  13. Suicidal Ideation Scale

    Questionnaire for suicidal ideation

    Time frame: Baseline and Follow-up (12 and 24weeks post randomisation)

  14. Vocational and Educational Functioning

    Measure of functioning in domains of work and education

    Time frame: Baseline and Follow-up (12 and 24weeks post randomisation)

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Study locations

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

Publications

  • Gajwani R, Sim F, McAllister K, Smith H, McIntosh E, Moran P, Ougrin D, Smith M, Gumley AI, Chanen AM, Minnis H. The BRIDGE project: a feasibility randomised controlled trial of brief, intensive assessment and integrated formulation for young people (age 14-24) with features of borderline personality disorder (Protocol). Front Psychiatry. 2024 Sep 24;15:1389578. doi: 10.3389/fpsyt.2024.1389578. eCollection 2024. PubMed 39381608 ↗

Study documents

  • Protocol and statistical analysis plan · Sep 15, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — 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.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05023447
Responsible party
Sponsor
First posted
Aug 26, 2021
Start date
Sep 1, 2021
Primary completion
Apr 30, 2024 (estimated)
Completion
Sep 30, 2024 (estimated)
Last update
Apr 26, 2024

Study contacts

Ruchika Gajwani, Dr
principal investigator · University of Glasgow

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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