The BRIDGE Project

NCT ID: NCT05023447

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2024-09-30

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.

Conditions

Borderline Personality Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

BRIDGE Intervention

Intervention Type: BEHAVIORAL

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

Service as Usual

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Service as Usual

Intervention Type: BEHAVIORAL

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

Interventions

BRIDGE Intervention

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

Intervention Type: BEHAVIORAL

Service as Usual

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Glasgow

OTHER

Sponsor Role: collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruchika Gajwani, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Locations

NHS Greater Glasgow and Clyde Clinical Research and Development Central Office

Paisley, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 39381608 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GN21MH147

Identifier Type: -

Identifier Source: org_study_id