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
Phase: NA
Conditions: Borderline Personality Disorder
Sponsor: NHS Greater Glasgow and Clyde

 
MQF20\25_BRIDGE Project_Protocol_ V 4.0 _26.04.20231 
 
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 
 
Running Title BRIDGE 
Protocol Version 5.0 
Protocol Date 15.09.2023 
IRAS Number: 299825 
R&D Reference Number: GN21MH147 
FUNDERS Number: MQ 
REC Number: 21/NW/0209 
Trial Registration:  
Sponsor: NHS GGC 
 
Funders: MQ (Rosetrees Trust and Jan Sczuzka’s legacy fund) 
 
Contact details – Chief Investigator & Co-Investigators  
Chief Investigator/Fellow 
 
Dr Ruchika Gajwani 
Clinical Psychology Senior Research Fellow 
School of Health & Wellbeing 
Clarice Pears Building  
University of Glasgow  
90 Byres Road 
Glasgow G12 8TB 
 
 
Tel. 01412019239  
e-mail: Ruchika.Gajwani@glasgow.ac.uk  
Co-Investigators 

 
MQF20\25_BRIDGE Project_Protocol_ V 4.0 _26.04.20232 
 
Professor Helen Minnis 
Professor of Child and Adolescent Psychiatry 
School of Health & Wellbeing 
Clarice Pears Building  
University of Glasgow  
90 Byres Road 
Glasgow G12 8TB 
 
. 01412019239 
e-mail: Helen.Minnis@glasgow.ac.uk 
 
Professor Andrew Gumley 
School of Health & Wellbeing 
Clarice Pears Building  
University of Glasgow  
90 Byres Road 
Glasgow G12 8TB 
 
email: andrew.gumley@glasgow.ac.uk 
 
Professor Andrew Chanen 
The University of Melbourne 
35 Poplar Road 
Parkville VIC 
Australia 
3052 
 
email: andrew.chanen@orygen.org.au 
 
 
 
KEY STUDY CONTACTS 
PhD student 
Ms Kirsty McAllister 
School of Health & Wellbeing 
Clarice Pears Building  
University of Glasgow  
90 Byres Road 
Glasgow G12 8TB 
 
 
Tel. 01412010233  
Email: 0107145M@student.gla.ac.uk  
Trial Manager 
Ms Kirsty Macleod 
School of Health & Wellbeing 
Clarice Pears Building  
University of Glasgow  
90 Byres Road 
Glasgow G12 8TB 
 
Email: kirsty.macleod@glasgow.ac.uk 
 

 
MQF20\25_BRIDGE Project_Protocol_ V 4.0 _26.04.20233 
 
Lead sponsor  
Ms Alison Hamilton NHSGG&C Research & 
Innovation 
Ward 11 Dykebar hospital 
Paisley  
PA2 7DE 
 
Tel: 01413144011 
Email: alison.hamilton@ggc.scot.nhs.uk  
Funder(s) 
 
 
 
MQ Mental Health Research 
6 Honduras St 
London 
EC1Y 0TH 
 
Email: mbolivar@mqmentalhealth.org 
 
 
CHAIR OF STUDY STEERING COMMITTEE 
TBC 
SIGNATURE PAGE 
Investigator agrees to conduct the study in compliance with the approved protocol and will 
adhere to the principles outlined in the Declaration of Helsinki, the Sponsor’s SOPs, and other 
regulatory requirement. 
I agree to ensure that the confidential information contained in this document will not be 
used for any other purpose other than the evaluation or conduct of the investigation without 
the prior written consent of the Sponsor 
I also confirm that I will make the findings of the study publically available through 
publication or other dissemination tools without any unnecessary delay and that an honest 
accurate and transparent account of the study will be given; and that any discrepancies from 
the study as planned in this protocol will be explained. 
 
Name 
Role 
Signature 
Date 
Dr Ruchika Gajwani 
Chief Investigator 
 
 
26/04/2023 
Name 
Role: 
Signature 
Date 
 
Ms Alison Hamilton 
NHS R&D Sponsor 
representative 
 
 
Table of Contents 

 
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1 
Synopsis ...................................................................................................................... 8 
2 
Trial/study summary .................................................................................................. 12 
2.1 
Participant flow diagram........................................................................................ 12 
2.2 
Trial summary ....................................................................................................... 13 
3 
Introduction................................................................................................................ 13 
3.1 
Background .......................................................................................................... 13 
3.2 
Rationale .............................................................................................................. 14 
4 
Trial objective(s) ........................................................................................................ 16 
4.1 
Objectives ............................................................................................................. 16 
4.2 
Primary outcome measures .................................................................................. 16 
4.3 
Secondary outcome measures ............................................................................. 16 
5 
Trial design ................................................................................................................ 17 
5.1 
Design……………………………………………………………….……………….18  
5.1.1      Participant recruitment…………………………………………………….….…………..18      
5.1.2    Intervention…………………………………………………………………………………18            
5.1.3   Comparison………………………………………………………….……………..………19                
5.2  
    Procedure…………………………………………………………….……………………19               
5.3 
    Measures……………………………………………………….…………………..20   
5.4           Process evaluation ……………………………………………………………………....20  
5.5           Health economics…………………………………………………………………………20 
6 
Recruitment details .................................................................................................... 21 
6.1 
Centre and Investigator selection .......................................................................... 21 
6.2 
Trial population ..................................................................................................... 21 
6.2.1      Inclusion Criteria………………………………………………………………………….22 
6.2.2     Exclusion criteria………………………………………………………………………….22 
6.3 
Number of participants .......................................................................................... 22 
6.4  
Recruitment and informed consent ....................................................................... 22 
7 
Data Collection .......................................................................................................... 23 
7.1 
   Confidentiality of personal data………………………………………………………….23 
7.2 
   Data collection forms……………………………………………………………………...24  
8 
Randomisation .......................................................................................................... 25 
9 
Withdrawal & loss to follow-up ................................................................................... 25 
10 
Intervention................................................................................................................ 26 
11 
Safety Reporting ........................................................................................................ 26 
11.2  
Definitions of adverse events ................................................................................ 27 
11.3  
Serious Advert Event ( SAE) ................................................................................. 27 
11.4  
Recording and reporting of adverse events .......................................................... 27 
11.5  
Annual safety reporting ......................................................................................... 28 
12 
Statistical considerations ........................................................................................... 28 
12.1 
Randomisation ...................................................................................................... 28 
12.2 
Sample size .......................................................................................................... 29 
13 
Analysis ..................................................................................................................... 29 
13.1 
Statistical Analysis Plan ........................................................................................ 29 
13.2 
Main analysis ........................................................................................................ 29 
14 
Data management ..................................................................................................... 29 
15 
Trial closure ............................................................................................................... 30 
16 
Regulatory issues ...................................................................................................... 30 
16.1 
Ethical and research governance .......................................................................... 30 
16.2 
Consent ................................................................................................................ 31 
16.3 
Confidentiality ....................................................................................................... 32 
16.4 
Indemnity .............................................................................................................. 32 
16.5 
Trial sponsorship .................................................................................................. 32 
16.6 
Funding ................................................................................................................ 33 

 
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16.7 
Audits & inspections ............................................................................................. 33 
17 
Trial management...................................................................................................... 33 
17.1 
Routine Management of Trial ................................................................................ 33 
17.2 
Trial  Steering Committee ..................................................................................... 34 
18 
Dissemination ............................................................................................................ 34 
19 
Timelines ................................................................................................................... 35 
20 
References ................................................................................................................ 36 
21       Appendix 1: Re-engagement Letter  
 
 
 
 
 
   37 
 
 
 
 
 
 

 
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Glossary of abbreviations 
ACES 
Adverse Childhood Experiences Scale 
ADHD 
Attention Deficit Hyperactivity Disorder 
AE 
Adverse Event 
ANCOVA 
Analysis of Covariants 
APR 
Annual Progress Report 
ASRS 
Adult ADHD Self-Reporting Scale 
ASSERT 
Autism Symptoms SElf-reporT for adolescents and adults 
BIS 
Brief Impulsiveness Scale 
BRIDGE 
Brief Intensive Assessment and Integrated Formulation 
BPD 
Borderline Personality Disorder 
BSL-23 
Borderline Symptoms List -23 
CAMHS 
Children and Adolescent Mental Health Services 
CAT 
Cognitive Analytic Therapy 
CI 
Chief Investigator 
CI 
Confidence Intervals 
CNORIS 
Clinical Negligence and Other Risks Indemnity Scheme 
CRN 
Clinical Research Nurse 
d-RCT 
Definitive Randomised Controlled Trial 
DSM-V 
Diagnostic Statistic Manual-V 
f-RCT 
Feasibility Randomised Controlled Trial 
GCP 
Good Clinical Practice  
GG&C 
Greater Glasgow & Clyde 
GP 
General Practitioner 
ICECAP-A 
ICEpop CAPability measure for Adults 
ISMS 
Intensive Support and Monitoring Service 
N 
Number of Participants 

 
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NHS GG&C 
National Health Service Greater Glasgow & Clyde 
NHS R&D 
National Health Service Research and Development 
NRES 
National Research Ethics Service 
PHQ-9 
Patient Health Questionnaire-9 
PI 
Principle Investigator 
PIS 
Patient Information Sheet 
PPIe groups 
Patient and Public Involvement and engagement 
RCT 
Randomised Controlled Trial 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SAU 
Service as Usual 
SDS 
Sheehan’s Disability Scale 
SSC 
Study Steering Group 
YPAG 
Young Person’s Advisory Group 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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1 
Synopsis 
Short 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 Centre  University of Glasgow & NHS GG&C  
Duration of Study  36 months  
Objectives 
To assess the feasibility of conducting a randomised controlled trial (f-RCT) 
of a BRIDGE, a brief intervention programme for young people (age 14-24) 
with early BPD (sub-threshold or threshold) in the general population of 
Glasgow, Scotland. 
Primary 
Objectives 
Are young people with early BPD willing to be randomised to BRIDGE (AND 
service as usual) or service as usual (ALONE) and can sufficient numbers of 
young people be recruited and retained such that a full-scale RCT is likely to 
be feasible? 
Primary outcome 
The two primary outcomes of this f-RCT are i. recruitment rates and ii. 
retention rates. The study will investigate the acceptability and 
appropriateness of our putative outcome measures for a future definitive 
randomised controlled trial (d-RCT). 
Rationale 
Young people with early BPD benefit from good clinical care and targeted 
intervention, however are regularly missed or mis-labelled. The feasibility trial 
in the general population would provide initial evidence of variable needs of 
young people with complex needs, who maybe missed from services as they 
don’t “fit” a model/diagnosis.  Workable multi-agency service model proposed 
in the trial would be a major advance in understanding care pathways 
regardless of trial outcome. 
Methodology  We plan to conduct an f-RCT following the Medical Research Council 
Complex Interventions Framework.  
Sample size 
Our pilot work suggests that the sample size (N=60) and timescale for 
recruitment and randomisation, intervention delivery and for follow-up data 
collection is appropriately estimated. The sample of the feasibility study is 
adequate to estimate clinical parameters of recruitment and retention. We will 

 
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use the standard deviations of the putative outcome measures used in this 
study for the power calculations for the definitive RCT. 
Screening 
The screening would include a two phased approach:  
Screening Phase 1  : Participants (accessed through a range of clinical 
and non-clinical settings in Glasgow) will self-complete the brief (15-
item) SCID-II PQ-BPD questionnaire. Potential participants can be 
either referred by a professional in a range of services in Glasgow (e.g. 
health, social, education) or can self-refer through advertisements in 
public places: everyone will complete either an online or paper 
screening assessment. Those meeting the cut off for the SCID-II PQ 
BPD (>11 out of 15) will be invited to Phase 2. SCID-II PQ-BPD has 
excellent psychometric properties and is used as a screening tool for 
BPD in outpatient youth. 
At Screening Phase 2, all potentially eligible participants will be invited 
for a short (< 30 minutes) interview conducted using the Structured 
Clinical Interview for DSM‐V Axis II Personality Disorders (SCID‐II) BPD 
module. The eligibility criteria for the study will be those who meet 
subthreshold (3 or 4 out of 9 domains) or threshold (5 and above out of 
9 domains) criteria on the SCID-II DSM-V, for intake to the BRIDGE 
study before randomisation.  
 
Randomisati On completion of the baseline data collection, consenting participants will be 
individually randomised 1:1 to BRIDGE plus service-as-usual (SAU) or SAU. 
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) 
 -  Aged between 14 and 24 years, until their 25th birthday 
Exclusion Criteria 
- Currently receiving psychological/counselling /psychotherapeutic treatment 
for BPD  
- Has received previous psychological intervention for Borderline Personality 
Disorder (BPD)/BPD Symptoms. 
- Severe or profound intellectual disability, that would preclude full 
engagement in talking therapy  

 
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- Receiving Intensive psychiatric treatment at the time of study entry, for 
conditions such as acute psychosis or severe eating disorder  
- Non-English speaking 
Intervention 
Brief, intensive assessment and integrated formulation (BRIDGE) 
intervention development has been guided by a) the emerging evidence base 
for Cognitive Analytic Therapy (CAT) with young people (aged 15-25) with 
BPD in an early intervention service and b) in collaboration with an 
established Glasgow intervention programme, called Intensive Support and 
Monitoring Service (ISMS), used in the Glasgow youth justice system. ISMS 
has the explicit focus of reaching a shared formulation with the young person 
and the multi-agency system that supports them.  
 
BRIDGE 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, 
copresenting 
difficulties, 
neurodevelopmental profile, life events history and psychosocial functional 
impact.  
Secondly, up to 16 sessions of Cognitive Analytic Therapy (CAT)14. 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. 
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. 
Statistical Analysis 
Analyses carried out in the f-RCT will remain blinded. Recruitment, retention 
rates and the BRIDGE sessions attended will be calculated with 95% 
confidence intervals (CI). A simple descriptive analysis of recruitment / 
retention relative to eligible / approached population will be conducted. While 

 
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underpowered, between-group change in each measure after adjustment for 
baseline will be estimated using analysis of covariance (ANCOVA). 
Economic Analysis and Treatment fidelity: For the economic analysis, data 
will be collected on cost of delivering the intervention in addition to participant 
use of health, personal social services and broader educational and societal 
resources. 

 
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2 
Trial/study summary  
2.1 
Participant flow diagram 
 
 

 
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2.2 
Trial summary  
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. 
3 
Introduction 
3.1 
Background 
Borderline personality disorder (BPD) is diagnosed on the basis of a pervasive pattern of 
instability of interpersonal relationships, self-image, and mood as well as marked impulsivity. It is 
a controversial diagnosis in young people, yet those with symptoms meeting criteria for BPD are 
frequently under-diagnosed, untreated, are not in employment or training and estranged from 
their families (1).  
BPD is the most common of personality disorders: in an adult population of 18 to 64-year olds, 
5% meet criteria for early borderline pathology and 1.1% meet full threshold criteria (2). BPD 
patients have complex needs and high suicide risk, high rates of psychiatric care, social service 
use , psychosocial morbidity and functional impairment (3), co-morbid mental health difficulties 
such as depression and substance misuse (2) and reduced life expectancy (4). BPD patients are 
typically seen in long term outpatient care or in crisis settings, increasing the potential for 
iatrogenic harm and worsening the stigmatisation of BPD (5). There is now good evidence that 
early intervention for BPD in young people can mitigate these negative long term outcomes (6), 

 
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yet young people with BPD are often left untreated and clinically unsupported and are less likely 
to make transition to adult mental health services (7). The implications of this neglect is long 
term, evident through poor social (3) and vocational functioning (8), and potential 
intergenerational harm.  
Young people with the persistent, complex needs characteristic of BPD – i.e. those with the 
poorest functioning and most complex psychiatric presentations - are often out of services by 
age eighteen (7). Barriers to diagnosis and treatment of BPD in young people include the myths 
that BPD diagnosis implies permanent disability in young people, will lead to clinical and self-
experiential discrimination (9), and to widening social, health and occupational disadvantage. 
There is evidence from randomised controlled trials (RCTs) for the effectiveness of specialised 
psychotherapies for BPD in adults(10) and more recently in young people (6), but 1) effects are 
small and unstable at follow-up and 2) do not match the scale of the problem 3) the interventions 
with demonstrable effect are expensive and 4) may not be scalable at a population level. 
3.2 
Rationale  
The worldwide social and health inequality gap is widening due to Covid-19 and will have 
serious implications for this most vulnerable group. Scalable approaches to mitigate the long-
term psychiatric and social effects of BPD, for the benefit of the whole population, is a public 
health priority now, more than ever (11). This study builds on pilot work demonstrating that multi-
modal recruitment methods, with excellent service user consultation, can achieve high 
recruitment rates of young people considered hard-to-reach. Having previously demonstrated 
effective recruitment from within this population, the present study seeks to assess the feasibility 
of conducting a randomised controlled trial of a brief intervention programme for young people 
aged 14-24 with sub- or full- threshold BPD, (i.e. ‘early BPD’) in the general population of 
Glasgow, Scotland.  
Primarily, we want to find out if recruitment and retention rates to a brief intervention for BPD 
symptoms in young people, are adequate to suggest a future full-scale RCT would be possible. 
Furthermore, we seek to investigate the acceptability and appropriateness of accepted outcome 
measures for a future definitive randomised controlled trial (d-RCT) which include, at the two 
follow-ups: [ i.] psychosocial functioning [ii.] Quality of life [iii.] emotional regulation [iv.] severity 
of depression [v.] impulsivity [vi.] severity of self-reported BPD symptoms. We will also attempt 
to capture care pathways for all participants, for the purposes of future modelling of health 
economics impacts, in relation to putative quality of life and functional outcomes measures. The 
findings will inform whether to progress to a definitive RCT and, if so, the design of a definitive 
trial of the BRIDGE intervention for the researchers to take forward to a large funder. It will also 
provide a more robust level of medium term evaluation of a BPD intervention for this population 

 
MQF20\25_BRIDGE Project_Protocol_ V 4.0 _26.04.202315 
 
than has previously been available, aiding practitioners and service managers in their decisions 
relating to BPD service provision. 
Timeliness: 
There is now good evidence that early intervention for BPD in young people can mitigate these 
negative long-term outcomes, yet young people with BPD are often left untreated and clinically 
unsupported and are less likely to make transition to adult mental health services. There is 
evidence from randomised controlled trials (RCTs) for the effectiveness of specialised 
psychotherapies for BPD in adults and more recently in young people, but 1) effects are small and 
unstable at follow-up and 2) do not match the scale of the problem 3) the interventions with 
demonstrable effect are expensive and 4) may not be scalable at a population level. 
NICE guidelines for BPD recommend that people with BPD should not be excluded from any social 
and health care services but, in practice, BPD sufferers experience discrimination and 
disengagement from specialist services which perpetuates social and health inequalities. 
The feasibility trial is a first to recruit young people with BPD symptoms, from the general 
population, who may otherwise be missed from specialist mental health services, especially in the 
current context of the pandemic, where the social and health inequalities are widening. By 
providing a treatment programme, which has an emerging evidence base in early intervention for 
BPD, the trial adds to the existing gaps in a) early identification (and description of variable needs) 
of BPD in the general population b) early intervention for young people through multi-agency work 
c) understanding care pathways regardless of trial outcome to reduce health inequalities for the 
vulnerable young people. 
Relevance 
Societal and professional attitudes to personality disorders, and the service provision that follows 
from these attitudes, have an important part to play in how services are delivered. One approach 
to furthering understanding of complex social/service delivery is ‘syndemics’, the term given to the 
co-occurrence of multiple, inter-related health problems at the individual- and population-level, 
developing and being sustained by harmful/unhelpful social contexts. Currently, BPD is viewed by 
many clinicians as intractable, entirely “trauma-related” and, where specialist services exist, 
treatment provision is delayed and limited to a few. Our own pilot study (‘Pathways study’) and 
work from other groups has shown that, despite their high psychiatric risk, young with BPD 
symptoms are less likely to be assessed/treated and often fall into the gap between 
child/adolescent and adult mental health services. 
Our syndemics approach is our key methodology for ensuring excellent interdisciplinary working. 
Syndemics is embedded within the research methodology, the multi-agency intervention 

 
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approach, our international network of collaborators, and the central role of young people at all 
stages of study design, delivery and dissemination 
4 
Trial objective(s)  
4.1 
Objectives  
To assess the feasibility of conducting a randomised controlled trial (f-RCT) of a BRIDGE, a brief 
intervention programme for young people (age 14-24) with early BPD (sub-threshold or 
threshold) in the general population of Glasgow, Scotland. 
4.2 
Primary outcome measures 
1. Are young people early in the course of BPD willing to be randomised to BRIDGE (AND service 
as usual) or service as usual (ALONE).  
2. Can sufficient numbers of young people be recruited and retained such that a full-scale RCT is 
likely to be feasible in the future? 
4.3 
Secondary outcome measures 
1. How acceptable are the trial processes and interventions to the participants?  
2. Can data systems be set up for assessment of both clinical and health economic outcomes in 
a future definitive randomised controlled trial (d-RCT)?  
3. Does the trial need adapting for participants in different settings (process evaluation and 
qualitative interviews)? 
 
The putative outcome measures for baseline and follow-up assessments have been selected after 
consulting the Delphi report from International Committee for Harmonization of Outcome 
Measures for Personality Disorder (http://www.netscc.ac.uk/hsdr/files/project/SDO_FR_08-1404-
083_V0 1.pdf).  
 
The f-RCT will investigate the acceptability and appropriateness of these measures for a future d-
RCT which include, at screening/pre-randomisation: SCID-II PQ-BPD; SCID-II DSM-V (BPD 
module); KIDSCREEN10; Pathways to Care and Demographics. Post randomisation: Mini 
International Neuropsychiatric Interview (MINI) 7.0.2 (18yrs+) and the Mini International 
Neuropsychiatric Interview (MINI-KID) 7.0.2 (under 18yrs); Adverse Childhood Experiences Scale; 
Autism Symptoms adolescents (ASSERT); Adult ADHD Self-Report Scale (ASRS). Baseline and 
follow-up: Borderline symptoms list (BSL-23); Sheehan’s Disability Scale (SDS); Difficulties in 

 
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Emotional Regulation Scale-SF; Patient Health Questionnaire-9; Quality of Life Questionnaire 
(EQ-5D);ICECAP-A; Suicidal Ideation Scale; Vocational and Educational functioning. 
5 
Trial design 
5.1 Design 
This proposed feasibility randomised controlled trial (RCT) will follow the Medical Research 
Council Complex Interventions Framework (Figure 1). We will randomise young people with 
symptoms of early BPD to BRIDGE (AND service as usual) or service as usual (ALONE) and 
explore aspects of feasibility using qualitative and quantitative methods. This will allow us to 
assess the feasibility of recruitment and retention of a sufficiently representative sample for a 
substantive RCT and help us determine the likely size of such a future definitive RCT.  
5.1.1 Participant recruitment 
Sixty young people (age 14-24) from Glasgow, experiencing symptoms of early BPD, will be 
recruited. Participants will be recruited through the following channels (approval dependent); 
- Referral from professional within the NHS GG&C (CAMHS, AMHS, GP, A&E) 
- Referral from professional within GCC education, social work, forensic services 
- Referral from third sector organisations  
- Self-referral through advertisements in public places (i.e. transport, libraries, social media) 
- Self-referral through re-engagement letter (see Appendix 1). This method of recruitment will 
aim to recruit participants that have disengaged subseqent to meeting the criteria for the study 
where consent has been given to be contacted.  
Professionals within each of the above services will be made aware of the study through 
conversations with the trial team. They will then be regularly asked if any patients on their 
caseload/service users meet inclusion criteria for the study, and can be approached for 
participation. With potential participants consent professionals will also have the opportunity to 
discuss potential referrals with the team. 
 The screening would include a two phased approach:  
Screening Phase 1: Participants (accessed through a range of settings in Glasgow) will self-
complete the brief (15- item) SCID-II PQ-BPD questionnaire. Potential participants can be either 
referred by a professional in a range of settings in Glasgow or can self-refer: everyone will 
complete either an online or paper screening assessment. Those meeting the cut off for the 

 
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SCID-II PQ BPD (>11 out of 15) will be invited to Phase 2. SCID-II PQ-BPD has excellent 
psychometric properties and is used as a screening tool for BPD in outpatient youth.  
At Screening Phase 2, all potentially eligible participants will be invited for a short (< 10 minutes) 
interview conducted using the Structured Clinical Interview for DSM‐V Axis II Personality 
Disorders (SCID‐II) BPD module. The eligibility criteria for the study will be those who meet sub-
threshold (3 or 4 out of 9 domains) or threshold (5 and above out of 9 domains) criteria on the 
SCID-II DSM-V, for intake to the BRIDGE study before randomisation.  
5.1.2 Intervention 
Brief, intensive assessment and integrated formulation (BRIDGE) intervention development has 
been guided by a) the emerging evidence base for Cognitive Analytic Therapy (CAT) with young 
people (age 15-25) with BPD in an early intervention service and b) in collaboration with an 
established Glasgow intervention programme, called Intensive Support and Monitoring Service 
(ISMS), used in the Glasgow youth justice system. ISMS has the explicit focus of reaching a 
shared formulation with the young person and the multi-agency system that supports them.  
BRIDGE 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, copresenting 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. 
5.1.3 Comparison 
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, mental-health 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. 
5.2 Procedure 

 
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Our three-month pre-trial set-up phase will establish a detailed system for managing referrals 
and randomisation and network between the various services from whom we would receive 
referrals (see section 5.1.1), including any self-referrals/completed online questionnaires. All 
potential participants will receive a 'Participant Information Leaflet' and a 'Trial Consent Form' 
prior to Screening 1.  
On completion of the Participant Information sheet (online or paper format) and consent form 
from young people (age 14-24), and from parents and assent from children (age 14-16 who are 
judged by a healthcare professional as incapable of providing consent), the trial research team 
(trial manager and research associate) will ensure eligible adolescents and young people are 
invited to screening 2 with a clinician, prior to study randomisation. Capacity to consent will be 
confirmed and documented by a healthcare professional at screening 2, prior to randomisation.  
Randomisation will be controlled by the Trial Team at the University of Glasgow, who will 
randomise patients (1:1) to BRIDGE (+SAU) or SAU. The trial manager will generate a 
randomisation list to ensure data collector blindness. The randomisation list containing the 
unique study ID and participant name will be stored in a password protected file within the Trial 
Team's private Microsoft Teams channel (following GDPR guidelines at the university of 
Glasgow secure server), and access will be restricted only to those members of the research 
team who will remain unblinded throughout the study. A log of access will be maintained.  
All participants consenting to participate will be invited to complete assessments, post 
randomisation, at baseline, 12 and 24 weeks follow up. A minimum data set of care pathways 
will be described at baseline and follow-up for all participants, for the purposes of future 
modelling of health economics impacts, in relation to putative quality of life and functional 
outcomes measures. Case-study methodology will be used to understand individual contexts, 
involving qualitative interviews with fourteen young people (seven from BRIDGE intervention and 
seven from SAU’s) and, where possible, their parents and relevant service providers. Topics will 
include acceptability of the three elements of BRIDGE, perceived mechanisms of change and 
exploration of requirements for data collection for a future d-RCT, including for future health 
economic evaluation. 
5.3 Measures 
The putative outcome measures for baseline and follow-up assessments have been selected 
after consulting the Delphi report from International Committee for Harmonization of Outcome 
Measures for Personality Disorder (http://www.netscc.ac.uk/hsdr/files/project/SDO_FR_08-1404-
083_V0 1.pdf). The f-RCT will investigate the acceptability and appropriateness of these 
measures for a future d-RCT which include, at screening/pre-randomisation: SCID-II PQ-BPD; 

 
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SCID-II DSM-V (BPD module); KIDSCREEN10; Pathways to Care and Demographics. Post 
randomisation: Mini International Neuropsychiatric Interview (MINI) 7.0.2 (18yrs+) and the Mini 
International Neuropsychiatric Interview (MINI-KID) 7.0.2 (under 18yrs); Adverse Childhood 
Experiences Scale; Autism Symptoms adolescents (ASSERT); Adult ADHD Self-Report Scale 
(ASRS). Baseline and follow-up: Borderline symptoms list (BSL-23); Sheehan’s Disability Scale 
(SDS); Difficulties in Emotional Regulation Scale-SF; Patient Health Questionnaire-9; Quality of 
Life Questionnaire (EQ-5D);ICECAP-A; Suicidal Ideation Scale; Vocational and Educational 
functioning.  
All the measures will be incorporated into a user-friendly questionnaire “book” and participants 
will have the option of completing on paper, in a telephone interview, or a mixture – a technique 
that has worked well in previous studies. These measures will be conducted, blind to group 
status, before and 12 and 24 weeks post randomization.  
Analyses carried out in the f-RCT will remain blinded. Recruitment, retention rates and the 
BRIDGE sessions attended will be calculated with 95% confidence intervals (CI). A simple 
descriptive analysis of recruitment / retention relative to eligible / approached population will be 
conducted. While underpowered, between-group change in each measure after adjustment for 
baseline will be estimated using analysis of covariance (ANCOVA). 
 5.4 Process evaluation 
Case-study methodology will be used to understand individual contexts, involving qualitative 
interviews with fourteen young people and, where possible, their parents and relevant service 
providers. Topics will include acceptability of the three elements of BRIDGE, perceived 
mechanisms of change and exploration of requirements for data collection for a future d-RCT, 
including for future health economic evaluation. 
5.5 Health economics 
For the economic analysis, data will be collected on cost of delivering the intervention in addition 
to participant use of health, personal social services and broader educational and societal 
resources. 
A minimum data set of care pathways will be described at baseline and follow-up for all 
participants, for the purposes of future modelling of health economics impacts, in relation to 
putative quality of life and functional outcomes measures. 

 
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6 
Recruitment details 
6.1 
Centre and Investigator selection 
This is a multi-site trial, with trial office located at the Department of General Practice within the 
University of Glasgow. The following documents will be in place and copies available in the Trial 
Master File before recruitment of participants: 
− 
A signed Study Agreement (CI and sponsor signature) 
− 
The approval  from the Centre’s R&D Department, or organisational approval from non NHS 
organisations  
− 
Completed Signature List and Roles and Responsibilities document 
− 
Completed contacts list of all site personnel working on the Study 
− 
Consent/assent form and PIS on letter headed paper 
 
The NHSGG&C is included as an identified site for this study as patient notes held by the 
NHSGG&C will be accessed by the trial team. If remote data collection/therapeutic work is not 
an  option for participants, they will be offered the opportunity to meet at an easily accessible 
location (e.g. GP surgery or public library). We will follow all local Covid guidance e.g. a phone 
call will be made to ensure that the participant is feeling well and has no symptoms prior to 
attending the appointment. 
 
6.2 
Trial population 
Sixty young people aged 14-24 screening for early BPD, will be randomised in a 1:1 ratio to 
receive either a) the brief intervention plus service-as-usual or b) service-as-usual alone. Follow 
up will be 12 weeks and 24 weeks post-intervention. This sample size is adequate to estimate 
clinical parameters for recruitment and retention.  Standard deviations of the putative outcome 
measures will facilitate power calculations for a future d-RCT. 
 
6.2.1 Inclusion Criteria 
- Cut off score of 11 out of 15 on the self-reported SCID-II BPD questionnaire (at screening 1 - 
see below) AND sub-threshold (3 or 4 out of 9 domains) or threshold (5 and above out of 9 
domains) criteria on the SCID-II DSM-V for BPD.  
-  Aged between 14 and 24 years, until their 25th birthday 
6.2.2 Exclusion criteria 

 
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Young people meeting the following criteria will be excluded:  
- Currently receiving psychological/counselling /psychotherapeutic treatment for BPD  
- Has received any previous psychological for Borderline Personality Disorder (BPD)/BPD 
Symptoms 
- Receiving intensive psychiatric treatment at the time of study entry, for conditions such as 
acute psychosis or severe eating disorder 
- Non-English speaking  
6.3 
Number of participants  
A formal sample size calculation is not appropriate for this feasibility trial: Our pilot work 
suggests that the sample size (N=60) and timescale for recruitment and randomisation, 
intervention delivery and for follow-up data collection is appropriately estimated. The sample of 
the feasibility study is adequate to estimate clinical parameters of recruitment and retention. We 
will use the standard deviations of the putative outcome measures used in this study for the 
power calculations for the definitive RCT.  
6.4 Recruitment and informed consent 
Participants can be either referred by a professional in a range of settings in Glasgow (for 
example, CAMHS, Social work, counsellors) or can self-refer by completing an online or paper 
screening assessment, the brief (15-item) SCID-II PQBPD questionnaire. 
Participants are being recruited from the general population, posters and leaflet's advertising the 
study will be disseminated at healthcare centres and other key sites guided by out PPIe group. 
Social media and public transport will also be key areas of advertisement for the study. 
Participants who express interest in the study to their referring practitioner or those who self-
refer from study publicity will speak to a member of the trial research team. During this call, the 
participants will be invited to complete a screening questionnaire to determine eligibility for the 
study. 
Following referral, and prior to completion of the eligibility screening form (online or paper 
format), the trial research team (trial manager and research associate) will ensure eligible 
adolescents and young people receive the study 'Participant Information Leaflet'. At least 24 
hours later, the research team will contact the young person to discuss the study further and 
seek consent. Informed consent from young people (14-24), and consent from parents of 
children (age 14-16 who are judged by a healthcare professional as incapable of providing 

 
MQF20\25_BRIDGE Project_Protocol_ V 4.0 _26.04.202323 
 
consent) will be obtained as well as assent from the child. Information, consent and assent 
procedures will be developed further with input from the first PPIe workshop and in consultation 
with the Study Steering Committee (SSC). Any consent forms in paper form will be stored at the 
University of Glasgow trial office in locked cabinets in the rooms with access limited to the 
research team. No one outside of the research team or appropriate governance staff will be able 
to find out participant’s details, or any other information which could identify them. Any consent 
forms held electronically will be stored in a secure, password protected study specific folder that 
is located on the university server facilities with access limited to the study team only. Access to 
information held on University computers will be password protected. Data will be held for 10 
years after the study has been completed, as per the applicable data security and management 
protocol. 
7 
Data Collection 
 
All qualitative data will be collected by the experienced researchers trained in the administration 
of the qualitative interviews. The data will be recorded on the recommended audio recording 
equipment (e.g. encrypted voice recorders), transcribed in house and digital format of the 
transcripts stored securely in the electronic study files located on the secured University IT 
infrastructure.  
All quantitative data will be collected via data collection forms developed by the trial team. The 
study will have data collection system allowing collection of participant’s research data where 
participant will be identified with the study specific participant number only.  
7.1 Confidentiality of personal data 
The study team works in line with General Data Protection Regulations (2018). All participants will 
be identified by a study specific number. No names or other personal identifiers will be used in 
data collection forms. Since name and address information are needed for participant’s follow up, 
the research team will use a master list matching study identifiers to this personal information. 
However, this list will be password protected, used only by the immediate study team and be kept 
in a study file accessible to only study team on a secure server within Research Institution. This 
information as indicated above will be kept separate from the research data, which constitute the 
research outputs of this study. Copies of consent forms will be kept in a locked filing cabinet in an 
office with a limited access to research team only. All assessment and questionnaire forms will 
only bare study specific ID number. Audio recordings will not directly address participants by their 
names but rather study specific number. Any personal details and any other identifying 

 
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characteristics will be removed before being stored in password protected file accessible by the 
research team only on secured University Servers or the secure trial MS Teams page 
7.2 Data Collection forms 
A user-friendly booklet will be developed by the trial team incorporating relevant demographic and 
health economic information, as well as the following psychometrics: 
Table 1. Baseline and follow-up assessments for the feasibility trial (The BRIDGE project) 
Measure* 
Baseli
ne 
12 
wks 
24 
wks 
What measuring?  
Questionnaires 
SCID-II PQ-BPD 
✓ 
✓ 
✓ 
BPD symptoms  (self-reported) 
SCID-II DSM-V (BPD module) 
✓ 
✓ 
✓ 
BPD criteria (>3 or above out of 9 domains)  
KIDSCREEN10 
✓ 
✓ 
✓ 
Overall Functioning  
Care pathways record and 
minimum data set 
✓ 
 
 
Demographics, pathways to care 
Questionnaires                                                                                                              Intensive assessment (BRIDGE) 
K-SADS/PL  
✓ 
 
 
Assessment of lifetime and present 
psychopathology 
Adverse Childhood Experiences 
Scale 
✓ 
 
 
Adverse childhood experiences 
Autism Symptoms adolescents 
(ASSERT) 
✓ 
 
 
Autism assessment 
Adult ADHD Self-Report Scale 
(ASRS) 
✓ 
 
 
ADHD symptom checklist 
Putative outcome measures                                                                                                       Possible mechanisms 
of change 
Borderline symptoms list (BSL-
23) 
✓ 
✓ 
✓ 
BPD symptom severity 
Sheehan’s Disability Scale (SDS) 
✓ 
✓ 
✓ 
Functioning: work/school, social and family 
life 
Difficulties in Emotional 
Regulation Scale-SF 
✓ 
✓ 
✓ 
Domains of emotional regulation  
Patient Health Questionnaire-9 
✓ 
✓ 
✓ 
Severity of depression  
Quality of life Questionnaire 
(EQ-5D) 
✓ 
✓ 
✓ 
General health related quality of life  

 
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ICECAP-A  
✓ 
✓ 
✓ 
Wellbeing assessment (Economic Evaluation) 
Suicidal Ideation Scale  
✓ 
✓ 
✓ 
Suicidal thinking and behaviours (ideation, 
self-harm, attempts) 
Vocational and Educational 
functioning 
✓ 
✓ 
✓ 
School and work (Paid and Unpaid) 
engagement 
 
* The outcome measures for baseline and follow-up assessments have been selected after 
consulting the Delphi report from International Committee for Harmonization of Outcome 
Measures for Personality Disorder (http://www.netscc.ac.uk/hsdr/files/project/SDO_FR_08-1404-
083_V01.pdf)  
 
8 
Randomisation 
Randomisation will be controlled by the Trial Team at the University of Glasgow, who will 
randomise participants (1:1) to BRIDGE (+SAU) or SAU (see section 10). The trial manager will 
generate a randomisation list to ensure data collector blindness. The randomisation list will be 
stored in a password protected file within the Trial Team's private Microsoft Teams channel, and 
access will be restricted only to those members of the research team who will remain unblinded 
throughout the study. A log of access will be maintained. 
9 
Withdrawal & loss to follow-up 
Participants have the right to withdraw consent for participation in any aspect of the BRIDGE trial 
at any time. The participants care will not be affected at any time by declining to participate or 
withdrawing from the trial.  
 
A participant may withdraw or be withdrawn from the intervention for the following reasons: 
− 
Withdrawal of consent by participant request 
− 
Any alteration in the participants condition or circumstances which justifies the 
discontinuation of the intervention in the investigators opinion  
 
If a participant is to be withdrawn, a discussion will take place with the participant – and if 
necessary with his/her legal representative. The data collected till the point of withdrawal will be 
retained and this will be clearly documented in participant information sheet and consent form. 
 
The research team will complete a withdrawal form for all participants who consent and 
subsequently withdraw. This withdrawal form will be retained in the study file. Any queries relating 
to potential withdrawal of a participant should be forwarded to the Trial Manager. 

 
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Upon recruiting participants to the trial, we will gather contact information for them and will explain 
the plans for future contact. The study does not involve a long period of contact with participants, 
and therefore we do not expect to lose contact with a high proportion of participants.  One of the 
aims of this study is to determine retention rates.   
10 
Intervention 
Brief, intensive assessment and integrated formulation (BRIDGE) intervention development has 
been guided by a) the emerging evidence base for Cognitive Analytic Therapy (CAT) with young 
people (age 15-25) with BPD in an early intervention service and b) in collaboration with an 
established Glasgow intervention programme, called Intensive Support and Monitoring Service 
(ISMS), used in the Glasgow youth justice system. ISMS has the explicit focus of reaching a 
shared formulation with the young person and the multi-agency system that supports them.  
BRIDGE is delivered over 3-6 months and has a three-fold focus:  
1)  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.  
2) Up to 16 sessions of Cognitive Analytic Therapy (CAT). 
3) 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, mental-health 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. 
11 
Safety Reporting  
11.1 Assessment of Safety 
For all participants the NHS GGC risk management procedures will be followed and risk 
assessments will be carried out prior to study visit. For participants held within clinical teams 
(example, CAMHS), this will be done in collaboration with the participant's clinical team. For 
participants who may have no service involvement, NHS GGC care planning and safety 

 
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procedures will be followed with GP's as point of contact. Participants will also be told if they 
disclose any risk to themselves or others, we are obligated to share this with their mental health 
professional/GP. The core research team (trial manager, PhD student, trial therapists) will 
receive training on risk assessment and management as the ACADEMIC CAMHS team is 
embedded with specialist children's services, NHS GGC. 
11.2 Definitions of adverse events 
Adverse Event (AE) – Any untoward medical occurrence in a subject to whom a trial intervention 
has been offered, including occurrences which are not necessarily caused by or related to that 
intervention.  
11.3 Serious Advert Event ( SAE) 
Serious Adverse Event (SAE): An untoward occurrence that: 
  
a) Results in death  
b) Is life-threatening*  
c) Required hospitalisation or prolongation of existing hospitalisation**  
d) Results in persistent or significant disability or incapacity  
e) Consists of a congenital anomaly or birth defect  
f) Other considered medically important by investigator 
11.4 Recording and reporting of adverse events 
All SAEs will be recorded during the study period to ensure participant’s safety and reported to the 
Principal Investigator (PI). Details of SAEs will be added to the SAE report form stored within the 
trial site files and followed until resolution. The relationship with the study intervention will be 
assessed for any unexpected SAEs: if considered related and unexpected these SAEs will be 
communicated to the PI for review and will be reported to the REC and the sponsor according to 
standard requirements. The Study Steering Committee will also monitor SAEs to ensure that 
participant’s safety is adequately monitored by those independent to the trial administration.   
Any SAE occurring to a research participant will be reported to the main REC (i.e. the REC that 
gave a favourable opinion of the study) where in the opinion of the Principal Investigator (PI), the 
event was: 
• “Related” – that is, it resulted from administration of any of the research procedures, and 
• “Unexpected” – that is, the type of event is not an expected occurrence. 
Reporting to the Sponsor 

 
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All Related, Unexpected SAEs (RUSAEs) must be reported to the Pharmacovigilance Office immediately 
(within 24 hours) using the generic non-CTIMP SAE form which is available from 
http://www.glasgowctu.org/data/SAE_non-CTIMP.pdf. The SAE form should be completed and signed by 
appropriately delegated staff.  The form should be faxed or e-mailed to the PV Office 
(pharmacovig@glasgowctu.org) and a copy placed in the Study Site File.  If necessary a verbal report can 
be given by contacting the PV Office on 0141 330 4744. This must be followed up as soon as possible 
with a signed written (or electronic) report.   
If all of the required information is not available at the time of initial reporting, the investigator must 
ensure that any missing information is forwarded to the PV Office as soon as this becomes available. The 
report should indicate that this information is follow-up information for a previously reported event. 
The Sponsor in liaison with the CI will carry out an assessment of expectedness prior to submission of the 
event to the REC. 
Reporting to the Research Ethics Committee (REC) 
The PV office will report all RUSAEs to the ethics committee within 15 days of the PV office becoming 
aware of the event, via the ‘report of serious adverse event form’ for non-CTIMPs published on the 
Health Research Authority web site. http://www.hra.nhs.uk/documents/2015/02/safety-report-form-
non-ctimp.docx. The form will be completed by the Sponsor and will be signed by the Chief Investigator 
prior to submission. 
  
The Data Monitoring and Ethics Committee will be notified of all such events whether considered 
to be related to the trial interventions or not. The co-ordinator of the main REC will acknowledge 
receipt of safety reports within 30 days. 
11.5 Annual safety reporting 
The PI is also responsible for providing an annual progress report to the REC using an NRES 
“Annual Progress Report form for all other research”. This form is available at: 
http://www.nres.npsa.nhs.uk/applications/after-ethical-review/annual-progress-reports/  
A section on the safety of participants is included in this report. 
12 
Statistical considerations 
12.1 Randomisation 
See section 9.  

 
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12.2 Sample size 
Sixty young people aged 14-24 screening for early BPD, will be randomised in a 1:1 ratio to 
receive either a) the brief intervention plus service-as-usual or b) service-as-usual alone. Follow 
up will be 12 weeks and 24 weeks post-intervention. This sample size is adequate to estimate 
clinical parameters for recruitment and retention.  Standard deviations of the putative outcome 
measures will facilitate power calculations for a future d-RCT. 
13 
Analysis 
13.1 Statistical Analysis Plan 
The study will have a comprehensive Statistical Analysis Plan (SAP), which will govern all 
statistical aspects of the study, and will be authored by the Trial Team in collaboration with a 
supporting Statistician before any unblinded data is seen.  
The Robertson Centre for Biostatistics, part of the Glasgow Clinical Trials Unit, a fully registered 
UK CRN Clinical Trials Unit, will support and advise on data analysis.  
13.2 Main analysis 
All statistical analyses will be pre-specified in a detailed Statistical Analysis Plan, to be finalised 
prior to unblinding of intervention groups, and agreed by the Trial Steering Group.  
Analyses carried out in the f-RCT will remain blinded. Recruitment, retention rates and the 
BRIDGE sessions attended will be calculated with 95% confidence intervals (CI). A simple 
descriptive analysis of recruitment / retention relative to eligible / approached population will be 
conducted. While underpowered, between-group change in each measure after adjustment for 
baseline will be estimated using analysis of covariance (ANCOVA).  
Economic analysis  
For the economic analysis, data will be collected on cost of delivering the intervention in addition 
to participant use of health, personal social services and broader educational and societal 
resources. 
Qualitative analysis 
Interviews will be transcribed verbatim and subject to a thematic analysis, where re-occurring 
topics/issues are identified across the dataset using rigorous qualitative analytical techniques.  
14 
Data management 
A Data Management Plan will be developed for the study in line with approved templates, reviewed 
regularly and all members of the project team will adhere to the plan.   

 
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The study team works in line with General Data Protection Regulations (2018). All participants will 
be identified by a study specific number. No names or other personal identifiers will be used in 
data collection forms. Since name and address information are needed for participant’s follow up, 
the research team will use a master list matching study identifiers to this personal information. 
However, this list will be password protected, used only by the immediate study team and be kept 
in a study file accessible to only study team on a secure server within Research Institution. This 
information as indicated above will be kept separate from the research data, which constitute the 
research outputs of this study. Copies of consent forms will be kept in a locked filing cabinet in an 
office with a limited access to research team only. All assessment and questionnaire forms will 
only bare study specific ID number. Audio recordings will not directly address participants by their 
names but rather study specific number. Any personal details and any other identifying 
characteristics will be removed before being stored in password protected file accessible by the 
research team only on secured University Servers or the secure trial MS Teams page. 
15 
Trial closure 
The trial will end when the SSC agrees that one or more of the following situations applies:  
1) The planned sample size has been achieved, and follow-up is complete;  
2) There is insufficient funding to support further recruitment, and no reasonable prospect of 
additional support being obtained;  
3) New information makes it inappropriate to continue to randomise patients to one or other arm 
of the trial;  
4) Recruitment is so poor that completion of the trial cannot reasonably be anticipated. 
16 
Regulatory issues 
16.1 Ethical and research governance  
The study will be carried out in accordance with the World Medical Association Declaration of 
Helsinki (1964) and all subsequent revisions. 
The study protocol and all participant documentation and procedures will be submitted to the 
relevant ethical review board of each study site for approval. As the study may include sites from 
the NHS, and other public places (e.g. public library) approvals will be obtained for each 
organisation using their usual ethical review procedures.  
Favourable ethical opinion will be sought from Research Ethics Committee in the UK before 
participants are entered into this clinical trial. Substantial amendments that require review by NHS 
REC will not be implemented until that review is in place and other mechanisms are in place to 

 
MQF20\25_BRIDGE Project_Protocol_ V 4.0 _26.04.202331 
 
implement at site.  Participants will only be allowed to continue in the study once they have 
provided written informed consent. 
− 
All correspondence with the REC will be retained. 
− 
REC annual reports will be generated as required. 
− 
The PI will notify the REC of the end of the study. 
− 
An Annual Progress Report (APR) will be submitted to the REC within 30 days of the 
anniversary date on which the favourable opinion was given, and annually until the study is 
declared ended. 
− 
If the study is ended prematurely, the Principal Investigator will notify the REC, including the 
reasons for the premature termination. 
− 
Within one year after the end of the study, the PI will submit a final report with the results, 
including any publications/abstracts, to the REC. 
16.2 Consent 
Following referral (section 5.1.1), and prior to completion of the eligibility screening form (online 
or paper format), the trial research team (trial manager and research associate) will ensure 
eligible adolescents and young people receive the study 'Participant Information Leaflet'. At least 
24 hours later, the research team will contact the young person to discuss the study further and 
seek consent. Informed consent from young people (14-24), and from parents and assent from 
children (age 14-16 who are judged by a healthcare professional as incapable of providing 
consent) will be obtained. Information, consent and assent procedures will be developed with 
input from the first PPIe workshop and in consultation with the Study Steering Committee (SSC). 
Any consent forms in paper form will be stored at the University of Glasgow trial office in locked 
cabinets in the rooms with access limited to the research team. No one outside of the research 
team or appropriate governance staff will be able to find out participant’s details, or any other 
information which could identify them. Any consent forms held electronically will be stored in a 
secure, password protected study specific folder that is located on the university server facilities 
with access limited to the study team only. Access to information held on University computers 
will be password protected. Data will be held for 10 years after the study has been completed, as 
per the applicable data security and management protocol. 

 
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16.3 Confidentiality 
Researchers from the University of Glasgow and collaborating partners will collect, store and 
process all personal information in accordance with the General Data Protection Regulation 
(2018).  
Any data in paper form will be stored at the University of Glasgow and collaborating institutions 
in locked cabinets in rooms with the restricted access. The study materials in the electronic 
format will be stored on secured password–protected computers linked to secured University 
servers. Data in the electronic format will have no links to the participants personal data and only 
study specific number will be used. The audio recording files will be recorded on the encrypted 
recording devices and uploaded into project dedicated study folder located on server with the 
restricted access to authorised researches only. No one outside of the research team or 
appropriate governance staff will be able to find out participant’s name, or any other information 
that could identify them. All participants will be provided with detailed description of their data 
handling in Participant Information Sheet. 
The data will be stored in archiving facilities in line with the University of Glasgow retention 
policy of up to 10 years. After this period, further retention may be agreed, or the data will be 
securely destroyed in accordance with the relevant standard procedures. 
16.4 Indemnity 
The BRIDGE trial is sponsored by the NHS Greater Glasgow & Clyde. NHS indemnity is provided 
under the Clinical Negligence and Other Risks Indemnity Scheme (CNORIS).  
The NHS has a duty of care to patients treated, whether or not the patient is taking part in a clinical 
trial, and the NHS remains liable for clinical negligence and other negligent harm to patients under 
its duty of care.  
NHS GG&C will provide indemnity and compensation in the event of a claim by, or on behalf of 
participants for negligent harm as a result of the study design and/or in respect of the protocol 
authors/research team.  
16.5 Trial sponsorship 
The NHS GG&C are the sponsors for the trial.  
The NHS R&I GG&C will ensure that the trial is performed in accordance with: 
− 
Conditions and principles of Good Clinical Practice (ICH GCP 1996). 
− 
Declaration of Helsinki (1964 and all amendments)  
− 
UK Policy Framework for Health and Social Care Research V3.3 07/11/2017. 
− 
The General Data Protection Regulation (EU 2016/679, 2016) 

 
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− 
Other regulatory requirements as appropriate. 
16.6 Funding 
Funder Grant Reference: MQF20\25 
Total Cost of Research (Research + NHS costs) £ 224,377.00   
The MQMH funding will begin on 16th April 2021.  
 
16.7 Audits & inspections 
The trial may be subject to inspection and audit by NHS R&D GG&C under their remit as co - 
sponsor. 
17 
Trial management 
17.1 Routine Management of Trial 
The trial will be co-ordinated from Glasgow by the Trial Management Group. This group 
normally includes those individuals responsible for the day-to-day management of the trial, 
such as the PI, other co-investigators and the Trial Manager. The role of the group is to 
monitor all aspects of the conduct and progress of the trial, ensure that the protocol is 
adhered to and take appropriate action to safeguard participants and the quality of the trial 
itself.  
The University of Glasgow core research team will comprise; the Chief Investigator, a part-time 
trial manager, and a full-time PhD student. Two DClinPsy students will also contribute to the trial 
as part of their research study during their doctoral training. 
The core research team will attend weekly project management team meetings, which will help 
facilitate the standardisation of research procedures/processes and to share experiences and 
lessons learned. Co-investigators will be kept up to date on study progress through regular 
meetings with individuals as required, and full co-investigator meetings will be scheduled 3 times 
annually. 
PPIe groups and YPAG will be attended by members of the trial management group, including 
project managers, co-investigators and/or the process evaluation researcher. Discussions from 
these groups will be fed back to the trial management group and SSC after every meeting, and 
group members will have options about how to provide feedback (e.g. reports, meeting minutes, 
group representative attending TMG or SSC meetings).  

 
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17.2 Trial  Steering Committee  
An independent Study Steering Committee (SSC) will be established and will meet approximately 
six times during the course of the study, consisting of an independent chair, and three other 
independent members. The members will be proposed by the CI.  
The role of the SSC is to provide overall supervision of the trial and ensure that it is being 
conducted in accordance with the principles of Good Clinical practice (GCP) and the relevant 
regulations. The SSC should:  
− 
Agree the trial protocol and any amendments  
− 
Provide advice to the investigators on all aspects of the trial  
− 
Have members who are independent of the investigators, in particular an independent 
chairperson  
 
Decisions about continuation or termination of the trial or substantial amendments to the protocol 
are usually the responsibility of the SSC.  
18 
Dissemination  
We will rapidly report findings in high profile peer-reviewed journals. We have well-developed 
dissemination routes to policy-makers through our wider academic team’s existing voluntary 
sector partnerships. Our PPIe groups and YPAGs will be key to this engagement work to ensure 
that Guidelines are presented in a framework of real world journeys through the service 
landscape. 
The parent/carer members of our PPIe group will be instrumental in disseminating our findings to 
the wider community of young people with symptoms of Borderline Personality Disorder. 

 
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19 
Timelines 
 
Calendar year
Calendar month J
J
A
S
O
N
D
J
F
M
A
M
J
J
A
S
O
N
D
J
F
M
A
M
J
J
A
S
O
N
D
J
F
M
A
M
J
J
A
S
O
N
D
J
F
M
A
Study year
Study month -7
-6
-5
-4
-3
-2
-1
1
2
3
4
5
6
7
8
9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 36 36 36 36
Patient and Public Involvement
Young Person's Advisory Group meetings (TRIUMPH network)
Workshop 1: YP with BPD (early engagement with trial design)
Workshop 2: Review process (recruitment, retention)
Workshop 3: Public, Patient, Commisioner Involvement 
Co-applicant/PhD (service user researcher)
Trail set-up
Obtaining Research Ethics/NHS approval for the trial
Set up trial office 
Recruit core staff (RA, intervention therapist)
Study website set-up 
Research assessment training
Trial management
Project management group
Trial Management Group ( Co-I) meetings 
Trial Scientific advisory Committee meetings
Fellowship mentor supervision
Recruitment and Data Collection 
Recruitment
Collection of baseline measures
Follow-up measures (12 weeks/24 weeks) post intervention
Process evaluation (Qualitative interviews, 7 each group )
Process evaluation with Multi-agency (Focus group, each group)
Data 
Data entry
Data cleaning
Data analysis
Outputs
Progress reports
ResearchFish Annual Report
Final report
Dissemination event/conference/YP's debate
Publications
Intervention
Delivery of trial intervention
Write up
Data analysis and write up
Pre-Funding
1
2
3
2020/2021
2021/2022
2022/2023
2023/2024

 
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20 
References 
1 Chanen A, Sharp C, Hoffman P, for Prevention GA. Prevention and early intervention for borderline personalit disorder: a novel public health priority. 
World Psychiatry. 2017;16(2):215. 
2 Have M, Verheul R, Kaasenbrood A, van Dorsselaer S, Tuithof M, Kleinjan M, et al. Prevalence rates of borderline personality disorder symptoms: a study 
based on the Netherlands Mental Health Survey and Incidence Study-2. BMC psychiatry. 2016;16(1):249. 
3 Moran P, Romaniuk H, Coffey C, Chanen A, Degenhardt L, Borschmann R, et al. The influence of personality disorder on the future mental health and 
social adjustment of young adults: a population-based, longitudinal cohort study. The Lancet Psychiatry. 2016;3(7):636-45. 
4 Fok ML-Y, Hayes RD, Chang C-K, Stewart R, Callard FJ, Moran P. Life expectancy at birth and all-cause mortality among people with personality disorder. 
Journal of psychosomatic research. 2012;73(2):104-7. 
5 Biskin RS. The lifetime course of borderline personality disorder. The Canadian Journal of Psychiatry. 2015;60(7):303-8. 
6 Chanen AM, Nicol K, Betts JK, Thompson KN. Diagnosis and Treatment of Borderline Personality Disorder in Young People. Current Psychiatry Reports. 
2020;22(5):25-. 
7 Singh SP, Paul M, Ford T, Kramer T, Weaver T. Transitions of care from child and adolescent mental health services to adult mental health services (TRACK 
study): a study of protocols in Greater London. BMC Health Services Research. 2008;8(1):135. 
8 Hastrup LH, Kongerslev MT, Simonsen E. Low vocational outcome among people diagnosed with borderline personality disorder during first admission to 
mental health services in Denmark: a nationwide 9-year register-based study. Journal of personality disorders. 2019;33(3):326-40. 
9 Sharp C. Bridging the gap: the assessment and treatment of adolescent personality disorder in routine clinical care. Archives of Disease in Childhood. 
2017;102(1):103-8. 
10 National Collaborating Centre for Mental Health (UK. (2009). Borderline personality disorder: treatment and management. British Psychological Society. 
11 Holmes EA, O'Connor RC, Perry VH, Tracey I, Wessely S, Arseneault L, et al. Multidisciplinary research priorities for the COVID-19 pandemic: a call for 
action for mental health science. The Lancet Psychiatry. 2020. 
 
 

 
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21 
Appendix 1  
Dear xxx,   
    
We are contacting you because you were referred to the BRIDGE Project in xxx and you met with us on xxx occasions, with the last follow up in xxx. In these 
appointments you shared a lot of information about your personal experiences and we value this a lot.  
 
We wanted to get in touch to let you know we have been contacted by eighty young people from Glasgow and we are still contacting people up until 
December 2023, if you are still interested in being part of the study.  
 
Here’s a reminder of what the study is about:- 
 
• 
Participants are 14-24 year olds living in Glasgow that are experiencing any of these difficulties:- managing their emotions; maintaining 
relationships; staying in school/college or work.  
• 
The study is exploring a community treatment programme using Cognitive Analytical Therapy (CAT) for young people with features of borderline 
personality disorder.  
• 
The study isn’t a clinical service, we don’t give diagnoses.  
    
If you’re interested in being part of the study please complete the questionnaire on our website - https://bridgeproject.co.uk/ or contact us on mvls-
bridge@glasgow.ac.uk and we can arrange a time to call you back.  We will have to ask you some questions again as things may have changed. If we don’t 
hear from you we will try to contact you by phone or text too. 
       
Yours sincerely, 
 
 
Dr Ruchika Gajwani (Principal Investigator)  
The BRIDGE Project  
Email: mvls-bridge@glasgow.ac.uk   
Phone: 0141 201 9239