Borderline Personality DisorderBRIDGENCT05023447
The BRIDGE Project
A study testing BRIDGE Intervention and Service as Usual in people with Borderline Personality Disorder, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial 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 more about this study
- Who is it for?
- Ages 14 to 24 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- BRIDGE Intervention and Service as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2021to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NHS Greater Glasgow and Clyde Clinical Research and Development Central Office
Paisley, PA2 7DE
About this study
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
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.
- Conditions
- Borderline Personality Disorder
- Being tested
- BRIDGE Intervention, Service as Usual
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRIDGE InterventionBehavioural
Intensive clinical assessment; >16 sessions of Cognitive Analytic Therapy (CAT); Development of a shared formulation
Service as UsualBehavioural
Likely to range from social services, mental-health services, forensic services to no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Service as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment & Retention rates
The number of participants recruited for randomisation and the number retained to follow-up (12 \& 24wks post randomisation).
Measured: Continuous over 3 year study period
Secondary outcomes (2)
Acceptability of trial processes and interventions
Explored through qualitative interviews
Measured: Continuous over 3 year study period
Process Evaluation
Theory of change and logic modelling will be explored to capture the process behind intervention effects.
Measured: Continuous over 3 year study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start1 Sep 2021
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Ruchika Gajwani, Dr, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023447
- Sponsor's protocol ID
- GN21MH147
- Acronym
- BRIDGE
- Status last verified
- Apr 2024
- First submitted
- 9 Jul 2021
- Last updated
- 26 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05023447
- Acronym / sponsor ID
- BRIDGE / GN21MH147
- Conditions
- Borderline Personality Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRIDGE Intervention (+Service as Usual) | Experimental | Behavioral: BRIDGE Intervention, Behavioral: Service as UsualBrief, 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. |
| Service as Usual | Active comparator | Behavioral: Service as UsualServices 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. |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRIDGE InterventionIntensive clinical assessment; >16 sessions of Cognitive Analytic Therapy (CAT); Development of a shared formulation | Behavioural | BRIDGE Intervention (+Service as Usual) |
| Service as UsualLikely to range from social services, mental-health services, forensic services to no intervention | Behavioural | BRIDGE Intervention (+Service as Usual), Service as Usual |
Primary outcome
Recruitment & Retention rates
Time frame: Continuous over 3 year study period
The number of participants recruited for randomisation and the number retained to follow-up (12 \& 24wks post randomisation).
2 secondary outcomes
Acceptability of trial processes and interventions
Time frame: Continuous over 3 year study period
Process Evaluation
Time frame: Continuous over 3 year study period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Derived from this study: PubMed 39381608Gajwani 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.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruchika Gajwani, Dr principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRIDGE Intervention and Service as Usual in people with Borderline Personality Disorder, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment & Retention rates (time frame: Continuous over 3 year study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05023447, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.