The BRIDGE Project

NCT05023447 | Active Not Recruiting

• 1 other identifier: GN21MH147
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Acceptability of trial processes and interventions

  Continuous over 3 year study period

• Process Evaluation

  Continuous over 3 year study period

Other Outcomes (14)

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

  Screening; Pre-randomisation

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

  Screening/Pre-randomisation

• KIDSCREEN-10 Index

  Screening/Pre-randomisation

Study Arms (2)

BRIDGE Intervention (+Service as Usual)

EXPERIMENTAL

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

Service as Usual

ACTIVE COMPARATOR

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

BRIDGE Intervention BEHAVIORAL

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

BRIDGE Intervention (+Service as Usual)

Service as Usual BEHAVIORAL

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

BRIDGE Intervention (+Service as Usual); Service as Usual

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (1)

NHS Greater Glasgow and Clyde Clinical Research and Development Central Office

Paisley, PA2 7DE, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39381608 DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• Ruchika Gajwani, Dr

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomized
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: August 26, 2021
• Study Start: September 1, 2021
• Primary Completion: April 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)