IMAGINATOR 2.0: Co-design and Early Evaluation of a Novel Blended Digital Intervention Targeting Self-harm in Young People
Phase: NA
Conditions: Self Injurious Behavior, Adolescent Behavior Problem, Child Behavior Problem, Mental Health Disorder
Sponsor: Imperial College London

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PROTOCOL 
 
IMAGINATOR 2.0: Co-design and early evaluation of a novel blended digital intervention 
targeting self-harm in young people 
 
Short title: IMAGINATOR 2.0 - co-design and early evaluation 
 
Chief 
Investigator: 
Dr Martina Di Simplicio 
 
Mood Instability Research Group 
Division of Psychiatry, Imperial College London 
2nd Floor, Commonwealth Building 
Du Cane Road 
London W12 0NN 
Email: m.di-simplicio@imperial.ac.uk 
 
Investigators:  
Dr Ben Aveyard 
Ms Nora de Bode 
Dr Lindsay Dewa 
Dr Nejra Van Zalk 
Professor Adam Hampshire 
Mr Aaron McDermott 
Ms Nusaybah Choudhury 
Ms Emily Morse 
Ms Saida Mohamed 
Dr Emily Gardner-Bougaard 
Ms Rachel Rodrigues 
 
Sponsor:  
Imperial College London 
 
Funder: 
NIHR i4i 
 
R&D Number: 
IRAS Number: 
REC Number:       
 
310211 
 
 
 
 

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AMENDMENT HISTORY 
Amendment 
No. 
Protocol 
Version 
No. 
Date 
issued 
Author(s) of 
changes 
Details of Changes made 
SA1 
2 
11/11/22 Rachel 
Rodrigues 
1. 
Included a flyer to be distributed in West 
London NHS Trust to recruit participants 
(attached flyer, 
Imaginator_flyer_v1_241022). 
2. 
Research Assistants embedded in the 
clinical teams in West London NHS Trust 
can contact young people under adult 
services directly to arrange a baseline 
screening visit, once the clinician has 
confirmed the young person is eligible 
and would benefit from the intervention. 
3. 
Included an additional measure, 
(State_motivation_for_reducing_self-
harm_scale_v1_11122), to be 
administered at the baseline screening 
visit and during the outcome 
assessments. 
4. 
Therapists (e.g. medical doctors trained to 
deliver the intervention) can deliver the 
IMAGINATOR intervention in addition to 
the CWPs/CAPTs based in CCAMHS and 
MINT teams.  
5. 
End of recruitment date planned for 
31.05.23, and end of study date changed 
from Jan 2023 to Dec 2023. 
6. 
Participants will be recruited from across 
any WLT team, in addition to CCAMHS 
and MINT teams. Other services in WLT 
were interested in delivering the 
intervention and so we have expanded 
this. Amended PIS to reflect this. 
7. 
Removed the inclusion criterion 
‘participants need to consent for their GP 
to be contacted’ as this was included in 
error in the initial protocol. 
 

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SA2 
3 
04/04/23 Rachel 
Rodrigues 
1. 
Two questionnaires measuring anhedonia 
have been added to the baseline 
screening and outcome assessments.  
2. 
One questionnaire to obtain written 
feedback on the intervention has been 
added to the post intervention outcome 
assessment. 
3. 
The inclusion criteria for participants has 
been updated based on feedback from 
clinicians involved in the study.  
4. 
The feedback interview topic guide has 
been included for approval.  
 
 
 
 
TABLE OF CONTENTS 
Synopsis………………………………………………………………………………………………………………………… 
4 
Key Abbreviations……………………………………………………………………………………………………….... 
7 
1. Background and Rationale………………………………………………………………………………………… 
8 
2. Case Series Evaluation...……………………………………………………………………………………………. 
13 
       2.1. Overview of Methodology………………………………………………………………………………… 
13 
       2.2. Co-production…………………………………………………………………………………………………… 
14 
2.3. Objectives…………………………………………………………………………………………………… 
16 
2.4. Endpoints…………………………………………………………………………………………………… 
16 
2.5. Study Design……………………………………………………………………………………………… 
17 
2.6. Participants………………………………………………………………………………………………… 
18 
2.7. Procedures………………………………………………………………………………………………… 
19 
2.8. Assessments and Questionnaires……………………………………………………………… 
25 
2.9. Data Analysis……………………………………………………………………………………………… 
28 
3. Ethics………………………………………………………………………………………………………………………… 
29 
3.1. Ethics Approval………………………………………………………………………………………….. 
29 
3.2. Risks and Benefits……………………………………………………………………………………… 
29 
3.3 Adverse Events…………………………………………………………………………………………… 
31 

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3.4. Informed Consent……………………………………………………………………………………… 
33 
3.5. Data Management and Participant Confidentiality…………………………………… 
34 
4.   Finance, Insurance and Audit………………………………………………………………………………… 
35 
       4.1. Indemnity………………………………………………………………………………………………………… 
35 
       4.2. Sponsor…………………………………………………………………………………………………………… 
35 
       4.3. Funding…………………………………………………………………………………………………………… 
36 
       4.4.  Audits….………………………………………………………………………………………………………… 
36 
5.   Publication Policy…………………………………………………………………………………………………… 
36 
6.   References……………………………………………………………………………………………………………… 
36 
 
 
SYNOPSIS 
 
Study Title 
IMAGINATOR 2.0: Co-design and early evaluation of a novel 
blended digital intervention targeting self-harm in young people 
Short Title 
Short title: IMAGINATOR 2.0 - co-design and early evaluation 
Planned Study Period Study period: June 2022 – December 2023 
Recruitment end date: 31st May 2023 
Study Design 
Case series 
Study Participants 
Participants are young individuals aged 12 to 25 years old who 
experience current repeated self-harm behaviour and are seeking 
support to manage and reduce self-harming via local mental health 
services.  
Number of 
Participants 
N = 20 
Intervention(s) 
IMAGINATOR intervention: Functional Imagery Training (3 x face to 
face sessions, 5 x follow up telephone support sessions) + 
IMAGINATOR app 

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Primary Objectives 
To assess the feasibility, acceptability and safety of the 
IMAGINATOR intervention consisting of Functional Imagery Training 
(FIT) supported by a smartphone app (IMAGINATOR app) in YP aged 
12-25 years old who self-harm.  
Secondary Objectives To explore potential effects of the IMAGINATOR intervention on the 
following outcomes: 
a) Changes in self harm frequency and severity  
b) Changes in mental health symptoms and functioning: low 
mood and anxiety, psychological wellbeing, suicidal thoughts 
and behaviour, engagement in other risky self-destructive 
behaviours including binge/purge behaviour and drug and 
alcohol misuse 
c) Emergency department visits 
d) Further treatment needs 
e) Maintenance of changes (from pre- to post-intervention) in 
the above outcomes at 6 months follow-up (3 months post-
intervention). 
 
To explore potential mechanisms involved in self-harm change:  
a) Change in the characteristics of mental imagery associated 
with self-harm when this is present 
b) Change in the urge to self-harm 
c) Change in emotion regulation ability. 
 
To explore potential effects of the IMAGINATOR app: 
a) The relationship between use of the IMAGINATOR app and 
change in the above outcomes from pre- to post-
intervention and at 6 months follow-up.  

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Primary Endpoints 
Feasibility: An indication of feasibility assessed by calculating 
treatment adherence indicators such as average number of therapy 
sessions completed by participants, the percentage of participants 
completing different components of the intervention (face-to-face 
sessions, phone calls), and attrition. 
 
Acceptability: An indication of acceptability assessed by calculating 
scores on Credibility/Expectancy Scales, the Client Satisfaction 
Questionnaire, User Experience Questionnaire, and by analysing 
qualitative data obtained through the Experience of Service 
questionnaire and semi-structured feedback interviews. 
 
Safety: Safety of the intervention determined by reviewing adverse 
events recorded at each assessment and therapy session/phone call 
contact. 

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Secondary Endpoints 
Potential effectiveness of the IMAGINATOR intervention: 
Change assessed from pre-FIT intervention to post-FIT intervention, 
and at 6 months follow up in the following outcomes: 
a) Average frequency of self-harm, and average severity of self-
harm scores 
b) Average scores on questionnaires of clinical, functional and 
process outcomes (see Assessments) 
c) Proportion of YP needing further treatment in CCAMHS or 
other WLT services vs can be closed to CCAMHS or other WLT 
services 
d) Emergency department visits. 
 
Potential mechanisms: 
Change assessed from pre-FIT intervention to post-FIT intervention, 
and at 6 months follow up in the following outcomes: 
a) Average scores on characteristics of mental imagery associated 
with self-harm when present (e.g. vividness, compellingness) 
b) Average scores of the urge to self-harm 
c) Average scores on emotion regulation ability measures.  
 
Potential effectiveness of the IMAGINATOR app: 
a) Correlations between endpoint scores (listed above) and the 
following measures of IMAGINATOR app use: number of app 
sessions/logins and total duration of app use, number of 
activity cycles completed, number of personalised77 media 
uploaded, number of completed guided imagery sessions, total 
duration of guided imagery completed and use of any other 
key functionalities at 6 months follow up.  
 
 
 
 
 
 

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KEY ABBREVIATIONS 
 
YP 
Young people 
YPAG 
Young Persons Advisory Group 
WLT 
West London NHS Trust 
CCAMHS 
Community Child and Adolescent Mental Health Services 
MINT 
Mental Health Integrated Network Teams 
FIT 
Functional Imagery Training 
CWP 
Child Wellbeing Practitioner 
CAPT 
Clinical Assistant Psychology Therapist 
SC 
Standard Care 
GSH 
Guided Self-Help 
 
 
 
 
 
 

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1. BACKGROUND AND RATIONALE 
 
The Problem with Self Harm 
 
Self-harm behaviour is an act of self-injury regardless of intent (NICE, CG133). Prevalence is high 
with an estimated 20% of young people (YP) under 25 self-harming (Gillies et al. 2018). 
 
Methods of self-harm can be broadly divided into self-injury (e.g., cutting, bruising, burning, self-
battery) and self-poisoning (most frequently overdose of prescribed or over-the-counter 
medication).  Method switching is common (Lilley et al., 2008) and co-occurrence of multiple 
methods is used as an index of severity (DSM-5, 2013). Individuals vary in the motives that drive 
and trigger self-harm. A recent study reported that getting “relief from a terrible state of mind" 
was the most common reason for self-harm in both boys and girls aged 14-16 (Rasmussen et al., 
2016). Motives also change from episode to episode: a study of over 30,000 adolescents in seven 
countries described that over 80% of those who had harmed themselves in the previous month 
reported more than one reason for self-harm, including wanting to get relief from a terrible state 
of mind, wanting to die and wanting to punish oneself (Scoliers et al., 2009). 
 
While most self-harm cases particularly in adolescents represent a form of transient distress, self-
harm is more prevalent in those who suffer from a mental disorder. Symptoms of depression, 
anxiety, as well substance abuse are risk factors for self-harm behaviour and in particular for its 
repetition. For example, those who start self-harming as young adults are more likely to have 
presented with symptoms of depression and anxiety since adolescence (Uh et al. 2021). 
Adolescents who self-harm also have poorer educational and social outcomes (Mars et al. 2014). 
Self-harm is the strongest risk factor for suicide (Wilkinson et al. 2011): with those who self-harm 
estimated to be 17 times more likely to die by suicide than those who do not (Morgan et al. 2017). 
 
In summary, self-harm in YP is a major social and healthcare problem. It represents significant 
morbidity, is often repeated, and has links to suicide, with substantial healthcare costs for the 
community. Effective early intervention would therefore be of great benefit. 
 
Current Interventions 
 
Unfortunately, most YP who self-harm do not receive adequate support (Rowe et al. 2014; Cox 
& Hetrick, 2017). Supporting adolescents who self-harm is challenging. This is likely because self-
harm is a secretive behaviour and associated stigma is a barrier to help-seeking (Rowe et al. 
2014, Gulliver et al. 2010). 
 
A number of psychological interventions, such as cognitive-behavioural therapy (CBT) and 
dialectical-behavioural therapy (DBT), have shown promise in the treatment of YP who self-harm 
(Iyengar et al., 2018) but most of the evidence has been based on single trials (Hawton et al., 
2015). 
 

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Two recent Cochrane reviews following up on Hawton et al. (2015) reported that there is still 
surprisingly little research on interventions for YP who self-harm (Witt et al., 2021a, 2021b). For 
example, of the interventions that have been studied, only DBT-A (DBT for Adolescents) has been 
shown to have positive effects on repetition of self-harm in adolescents and results are not 
entirely replicated in older adult samples. Implementation of interventions such as DBT in routine 
clinical practice is limited and complex because these interventions have only been tested in 
selected populations (such as those with a specific diagnosis) and require long commitment to 
therapy: for example, DBT-A is a resource intensive intervention, typically taking 6 months (i.e., 
24 x1 hour sessions) to complete and including individual and group formats. So, it is costly, not 
easily available in health services under financial pressure and may not suit all YP. Moreover, 
while data suggest that YP minoritised by ethnicity, sexual orientation and gender identity have 
additional risk factors and different patterns of presentation and help-seeking (Williams et al., 
2021; Gulliver et al.,2010), current interventions are not tailored to these specificities and needs.  
 
As a result, there is a gap in the provision of targeted support, especially for YP with mild to 
moderate self-harm severity who could benefit from an early intervention (McManus et al., 
2019). It has been recommended that, in light of the extent of the problems associated with self-
harm, there is a need to pay more attention to developing and evaluating specific therapies for 
this population (Witt et al., 2021a) and an important future direction is to develop brief 
efficacious interventions that may be scalable to reach large numbers of youth (Glenn et al. 
2019). 
 
Digital Health Interventions (DHIs): Technology based interventions offer the potential for 
improved availability of immediate 24/7 support that is accessible at distance and with 
reduced stigma and resource cost. Not surprisingly, the National Health Service (NHS) is 
encouraging the use of scalable low-cost technology to provide health support and 
interventions as a means of addressing increased service demand (NHS England, 2017). 
 
DHIs could provide particularly effective ways to reach adolescents with 83% of 12- to 15-year-
olds owning a smartphone and 81% using this to go online (Ofcom, 2021). A systematic review 
and meta-analysis investigating the effectiveness of standalone DHIs for the self-management of 
suicidal ideation or self-harm (Witt et al., 2017) found some support for reduction of suicidal 
ideation (but not self-harm or attempted suicide) and concluded that further evidence on the 
safety and potential mechanisms of action of these interventions was needed before they could 
be recommended. 
 
A systematic review of mobile health technology interventions (Melia et al., 2020) reported a 
proliferation of mobile health apps in recent years with around 10,000 health apps for mental 
health support alone at that time. Few of these apps had been developed specifically for YP and 
the rate at which new apps were being developed far exceeded the rate at which they were being 
scientifically evaluated (Melia et al., 2020).  
 
Mobile apps are considered acceptable by YP who self-harm as potential self-help or guided-help 
tools (Arshad et al., 2020). Specifically recent qualitative findings (Čuš et al., 2021) indicate that 

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what YP want from mobile apps for self-harm is the ability to respond to a variety of needs and 
contexts (e.g., before and during an acute distress state, as well as after self-harming) and for 
apps to be easy to use in the aforementioned contexts (e.g., having immediate visual elements 
rather than long text to read). Initial evidence on digital tools suggest that approaches that 
include human connection are preferred by YP and also improve outcomes (Hollis et al., 2017; 
Dewa et al., in press; Kavanagh et al., 2014). Despite the unmet clinical need, to date only a 
handful of digital interventions for self-harm have undergone initial evaluation.  
 
A recent scoping review (Cliffe et al., 2021) of mobile health interventions specifically supporting 
individuals who self-harm concluded that these are promising tools. However, most interventions 
to date have been developed and tested almost exclusively with White adult female populations 
and are not currently publicly available. Among the interventions reviewed, i.e. those that have 
undergone some form of scientific evaluation, most apps have been developed targeting self-
harm in selected clinical populations (e.g., depression, borderline personality disorder), or 
settings, (e.g. suicidal adolescents discharged from acute inpatient stay, US army veterans), or 
without user-involvement (Cliffe et al., 2021). There are only 2 smartphone apps specifically 
developed for and generalisable to support all YP with self-harm: BlueIce and ERITA. 
 
BlueIce (Stallard et al., 2018) has been co-developed with adolescents with lived experience and 
clinicians in the UK and is undergoing a feasibility RCT. It utilises techniques from DBT and CBT 
(the forms of traditional therapy that have some evidence of reducing self-harm so far) and 
includes monitoring symptoms. BlueIce is on the NHS app register and is available to CAMHS 
services on subscription. Limitations include that BlueIce has minimal personalisation and no user 
segmentation, is limited to adolescents and does not have a protocol for clear integration with 
clinician contact. 
 
ERITA (Bjureberg et al., 2018) is an app that accompanies an internet-based emotion regulation 
treatment for adolescents (called ERITA) developed in Sweden and undergoing an efficacy RCT 
(NCT03353961). The treatment involves completing 12 weekly online modules (and offers 
parallel modules for parents). The app is integrated in the treatment and includes monitoring 
symptoms and suggestions for coping strategies related to what is learned in the module. 
However, ERITA also has minimal personalisation and no user segmentation and still requires a 
relatively long commitment to 12 structured sessions. Also, it does not include any direct clinician 
contact. 
 
In summary, current interventions targeting self-harm in adolescents are time-consuming and 
costly, and do not reach the majority of those who self-harm. DHIs offer a potential avenue for 
delivering quick scalable support, promoting self-management and overcoming current barriers 
to treatment. To date, studies on app-based DHIs are few, and the DHIs / apps developed so far 
are limited to some groups and do not respond to all YP’s preferences.  
 

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Increasing access to evidence based psychological interventions for YP: Whilst the number of 
children referred to CAMHS in England rose by 35% from 2018/19 to 2019/20, the number of 
children receiving treatment only rose by 4% in the same period (Lennon, 2021), highlighting a 
large unmet need. 
 
Traditional service delivery models (where therapy is provided only by highly trained mental 
health professionals) limit access to evidence-based treatments (Kazdin & Rabbitt, 2013). In their 
paper examining novel models for delivering accessible, scalable, affordable and feasible mental 
health services, Kazdin and Rabbit (2013) discuss task-shifting and disruptive innovation, among 
other models. Task-shifting aims to strengthen and expand the healthcare workforce by 
redistributing service delivery tasks to individuals with less training than traditional healthcare 
workers and examples of disruptive innovation mostly involve the use of new technologies (e.g., 
increasing accessibility by delivering services online). 
 
The Five Year Forward View of Mental Health (NHS England, 2017) led to funding being made 
available to train a new workforce of low-intensity Children and Young People IAPT therapists 
with a one year post graduate training. These ‘Children’s Wellbeing Practitioners’ would increase 
access to evidence-based interventions for mild to moderate common mental health problems 
in line with a task transfer rationale (Ludlow et al. 2020), and with adult mental health service 
provision already offering a range of low-to-moderate intensity interventions across primary and 
secondary care. 
 
Finally, another limitation in current mental health services is the artificial barrier at age 18, which 
is not designed to support the transition from adolescence to adulthood when self-harm, and 
other mental health problems, occur most. Accordingly, the NHS’ long-term plan also aims to 
transform services towards providing a continuous comprehensive offer of care to 16-25 years 
old YP (NHS, 2019). Therefore, it is important to develop interventions designed and tested to 
span across this transition period to overcome a situation where an intervention may be available 
for someone at age 17 years and 9 months, but not 4 months later (or vice versa) due to 
differences in access thresholds between adolescent and adult services.   
 
The Role of Mental Imagery in Self-harming Behaviour 
 
YP who self-harm report vivid mental imagery of hurting themselves, such as details of tools and 
the action sequence to be performed, or the consequence (blood gushing) and the sensation of 
intense relief often generated by the actual act (Di Simplicio et al. 2020). 
 
Playing out mental imagery of future scenarios in the “mind’s eye” can have a powerful impact 
on behaviour (Renner et al., 2019). Following evidence of strong suicidal imagery in affective 
disorders that can predict change in suicidality (Ng et al., 2016), self-harm imagery has been 
added to the risk factors for the transition from contemplating self-harm to acting on the idea, 
as formulated in the Integrated Motivational Volitional model of self-harm (O’Connor & Kirtley, 
2018; Wetherall et al., 2018).This model is one of the most prominent explanatory frameworks 
of suicidal behaviour and is applicable to understanding self-harm irrespective of intent 

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(O’Connor & Kirtley, 2018). It proposes that self-harm behaviour develops via a motivational and 
a volitional phase, i.e. from a phase when self-harm ideation starts to a phase when ideation 
turns into action with numerous contributing elements including cognitive factors with strong 
motivational properties such as mental imagery. The role of mental imagery in driving behaviour 
may be explained by its ability to emulate real-life experiences, and so its effect on emotion and 
motivation is much stronger than that of verbal-based cognitions (i.e. thoughts) (Holmes & 
Matthews, 2010; Ji et al., 2019). 
 
Targeting Mental Imagery in Self-harm 
 
Following on from the above evidence of the role of imagery in amplifying emotion and 
motivation, recent studies show that mental imagery interventions such as Functional Imagery 
Training (FIT) can be more effective than Motivational Interviewing at promoting change of 
problematic behaviours (Solbrig et al., 2018). Therapeutically targeting mental imagery in 
conjunction with Motivational Interviewing may therefore have a more profound effect on 
reducing self-harm behaviour and promoting more adaptive behaviour in line with YP’s goals. 
 
IMAGINATOR is a novel imagery-based intervention targeting self-harm (Di Simplicio et al. 2020). 
It is a blended digital intervention (i.e. combining direct clinical contact with a digital component) 
delivering Functional Imagery Training (FIT) (May et al., 2015) via therapist sessions, follow-up 
telephone sessions and a smartphone app (the “IMAGINATOR” app). FIT teaches individuals to 
use positive goal imagery that helps them resist the urge to self-harm in moments of distress and 
engage in an alternative behaviour. Vivid imagery of positive rewarding goal behaviours makes 
these feel close, desirable and easy to plan. For example, compelling imagery of running freely in 
nature or of a soothing warm drink with a friend harnesses motivation to put this into practice 
instead of self-harming. FIT broadly falls under CBT approaches and is derived from the 
Elaborated Intrusion Theory, a cognitive theory of desire and motivation backed by decades of 
research (May et al., 2015, Solbrig et al., 2019), which has been applied to other fields of 
behaviour change (dieting, exercise, addiction) (Di Simplicio et al., 2020). The IMAGINATOR app 
was previously developed together with YP with lived experience of self-harm as an Android-only 
app with the scope to support training the new imagery-based strategies developed in the FIT 
therapy sessions. 
 
Our first proof-of-concept study compared IMAGINATOR (for brevity, we will refer to FIT plus the 
IMAGINATOR app as “IMAGINATOR”) with treatment as usual in 38 YP aged 16-25 years old, and 
showed a medium-to-large effect size (d = 0.65-0.75 [CI: 0.3–16.1]) reduction of self-harm over 6 
months following IMAGINATOR (Di Simplicio et al., 2020). Eighty-two % of participants said they 
would recommend the intervention to a friend. No adverse events were reported. Qualitative 
feedback highlighted that YP valued the focus on developing goals, positive emotions and 
motivational tools rather than unpacking negative cognitions (Maschauer et al., in prep). Mental 
imagery was also valued as a coping strategy that was easy to apply whilst maintaining privacy 
(“I can do it anywhere and nobody knows I am doing it”) (Maschauer et al., in prep). 
 

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This work suggests that IMAGINATOR could be feasible, acceptable and helpful at reducing self-
harm in YP with a potential for reaching those who often fall in the gap of current provision. 
 
Need for Improvement, Re-design and Adaptation of IMAGINATOR 
 
Evidence from the literature, our proof-of-concept study, working with NHS clinicians and with 
our Young Person’s Advisory Group (YPAG) has since highlighted several limitations of the current 
IMAGINATOR intervention and the need for improvement.  
 
Clinicians from NHS Children and Adolescent Mental Health Services (CAMHS) via workshops and 
presentations suggested that IMAGINATOR should be extended and made available to younger 
teenagers too (e.g. from age 12), as self-harm tends to start earlier than 16 years old and 
IMAGINATOR could hold promise in particular as an early intervention. Our YPAG agreed with 
this need and indicated that IMAGINATOR can be suitable for YP across the teenage-young adult 
age range, but provided that users can choose between a few different options of the app’s look 
and modules to use. This reflects previous literature (Hetrick et al., 2020) suggesting the need for 
user segmentation around how an app feels, and modality of usage such as data tracking or 
gamification. YP also report that triggers and self-help strategies are often idiosyncratic (Gillies  
et al., 2018) further highlighting the importance of personalisation and the need to increase this 
drastically in the IMAGINATOR app.  
 
Building on our proof-of-concept study, there is therefore a need for a further adaptation and 
development stage of the IMAGINATOR intervention before its efficacy can be tested in a 
randomised controlled trial. In particular, there is a need for: 
 
• An iOS version of the app 
• A new app design and functionalities to include a degree of personalisation, segmentation, 
inclusivity and modularity 
• Tailoring the intervention to better serve the needs of minoritised YP 
• Adapting the intervention to younger teenagers. 
 
 
2. CASE SERIES EVALUATION 
 
 
2.1 OVERVIEW OF METHODOLGY 
 
We will run a case series study that investigates the IMAGINATOR intervention comprising of 
delivery of Functional Imagery Training (FIT) for self-harm supported by a new co-designed 
smartphone app to YP aged 12-25 who experience current repeated self-harming behaviour and 
have been referred to WLT teams, which includes the adult community mental health services 
(Mental Health Integrated Network Teams; MINT) and the Community Child and Adolescent 
Mental Health Services (CCAMHS). For the purpose of this study, self-harm is defined as per NICE 

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guidelines (NICE, 2012): “an act of self-poisoning or self-injury, irrespective of the apparent 
purpose of the act”.  
  
A case series is a descriptive study that follows a group of patients who have a similar diagnosis 
or who are undergoing the same procedure over a certain period of time and is the most 
appropriate design for reporting on a novel therapeutic intervention with a new population. The 
IMAGINATOR intervention has been tested with 16-25 year olds using a proof of concept trial (Di 
Simplicio et al., 2020) but as the current study proposes to also include younger participants (12-
17 year olds) and a newly developed version of the IMAGINATOR app, a case series is the optimal 
design to assess the feasibility and acceptability of the new IMAGINATOR intervention following 
further protocol/materials development and with a different population. 
 
The IMAGINATOR intervention provides three sessions of FIT + Standard Care (SC), followed by 
phone support sessions and smartphone app-based support, based on cognitive behavioural and 
motivational interviewing principles and in line with NICE guidelines for long-term management 
of self-harm behaviour.  FIT is intended as a brief and focused transdiagnostic intervention that 
can be added to any other pharmacological or non-concurrent psychological therapy. To improve 
YP’s access to and engagement with the intervention, we will deliver FIT face-to-face and 
encourage participants to support their therapy by using the new IMAGINATOR smartphone app. 
 
The study will be based in the West London NHS Trust.  
 
2.2 CO-PRODUCTION 
 
All stages of the study (design, recruitment, testing, analysis and interpretation of results) will be 
co-produced with our Young Person’s Advisory Group (YPAG), four YP with lived experience of 
self-harm and other mental health difficulties. Details of co-production are outlined below. 
 
IMAGINATOR app co-design: We followed a participatory design approach to co-develop the 
new IMAGINATOR app around the core functionality of supporting and training adaptive mental 
imagery. The YPAG worked with the research team to find and select a group of 14 YP with lived 
experience of self-harm to co-design the app, ensuring the group covered a wide age range (12-
25 years old), gender and those minoritised by ethnicity, gender identity and sexual orientation. 
The clinicians’ contribution enabled us to maximise opportunities and identify obstacles to 
integrating app use, sustainability and clinical input. 
 
The app was designed based on the Design Council’s Double Diamond Process (Figure 1), via a 
series of structured half day co-design workshops with key stakeholders (YP, clinicians), research 
team members, app designers and software developer. The YPAG co-facilitated all workshops 
with the research team.  
 
Once the app prototype was produced, we conducted structured usability testing to refine the 
app design, and in-house alpha testing to exclude any potential issues with the prototype, 

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2.3 OBJECTIVES  
 
Primary Objective 
 
The primary objective of this research is to assess the feasibility, safety and acceptability of the 
IMAGINATOR intervention consisting of Functional Imagery Training (FIT) supported by a 
smartphone app (IMAGINATOR app) in YP aged 12-25 years old who self-harm.  
 
Secondary Objectives 
 
The secondary objectives of the research are to explore:  
 
1) Potential effects of the IMAGINATOR intervention on the following outcomes: 
a) Changes in self harm frequency and severity  
b) Changes in mental health symptoms and functioning: low mood and anxiety, 
psychological wellbeing, suicidal thoughts and behaviour, engagement in other risky self-
destructive behaviours 
c) Emergency department visits 
d) Further treatment needs 
e) Maintenance of changes (from pre- to post-intervention) in the above outcomes at 6 
months follow-up (3 months post-intervention). 
 
2) Potential mechanisms involved in self-harm change:  
a) Change in the characteristics of mental imagery associated with self-harm when this is 
present 
b) Change in the urge to self-harm 
c) Change in emotion regulation ability. 
 
3) Potential effects of the IMAGINATOR app: 
a) The relationship between use of the IMAGINATOR app and change in the above outcomes 
from pre- to post-intervention and at 6 months follow-up.  
 
2.4 ENDPOINTS 
 
Primary Endpoints 
 
Feasibility: An indication of feasibility assessed by calculating treatment adherence indicators 
such as the average number of therapy sessions completed by participants, the percentage of 
participants completing different components of the intervention (face-to-face sessions, phone 
calls), and attrition (the percentage who complete post-intervention assessment). 
 

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Acceptability: 
An 
indication 
of 
acceptability 
assessed 
by 
calculating 
scores 
on 
Credibility/Expectancy Scales, the Client Satisfaction Questionnaire, User Experience 
Questionnaire and other bespoke acceptability measures identified by the YPAG, and by 
analysing qualitative data obtained through the Experience of Service questionnaire and semi-
structured feedback interviews. 
 
Safety: Safety of the intervention determined by reviewing adverse events recorded at each 
assessment and therapy session/phone call contact. 
 
Secondary Endpoints 
 
Potential effectiveness of the IMAGINATOR intervention: 
Change assessed from pre-FIT intervention to post-FIT intervention, and at 6 months follow up 
in the following outcomes: 
a) 
Average frequency of self-harm, and average severity of self-harm scores over the past 
3 months 
b) 
Average scores on questionnaires of clinical, functional and process outcomes (see 
Assessments) 
c) 
Proportion of YP needing further treatment in CCAMHS/MINT/other WLT services vs can 
be closed to CCAMHS/MINT/other WLT services 
d) 
Emergency department visits. 
 
Potential mechanisms: 
Change assessed from pre-FIT intervention to post-FIT intervention, and at 6 months follow up 
in the following outcomes: 
a) 
Average scores on characteristics of mental imagery associated with self-harm when 
present (e.g. vividness, compellingness) 
b) 
Average scores of the urge to self-harm 
c) 
Average scores on emotion regulation ability measures.  
 
Potential effectiveness of the IMAGINATOR app: 
a) Correlations between endpoint scores (listed above) and the following measures of 
IMAGINATOR app use: number of app sessions/logins and total duration of app use, 
number of activity cycles completed, number of personalised media uploaded, number of 
completed guided imagery sessions, total duration of guided imagery completed and use 
of any other key functionalities at 6 months follow up.  
 
2.5 STUDY DESIGN  
 
IMAGINATOR is a case series study describing FIT as a low intensity intervention alongside 
standard care (SC) in a sequential sample of YP referred to any WLT team, in addition to CCAMHS 
or MINT. 
 

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The design includes the following elements and study phases:  
 
1. Baseline Screening Visit  
2. Intervention: 3 x 1 hour FIT sessions delivered face-to-face by a Child Wellbeing 
Practitioner (CWP),  Clinical Assistant Psychology Therapists (CAPT) or therapist 
3. Follow up: 5 x support sessions delivered over the phone (the first one in week 4, then 
fortnightly) 
4. Smartphone app-based reminders, exercises and support from the second FIT session 
5. Outcome assessments within a week of final session (at the end of intervention), and at 3 
months post intervention  
6. User-led feedback interviews with participants upon study completion (after final 
assessment). 
 
2.6 PARTICIPANTS 
 
Participants are young individuals aged 12 to 25 years old who experience current repeated self-
harm behaviour and are seeking support to manage and reduce self-harming via local mental 
health services.  
 
Inclusion Criteria 
 
1. Aged 12 - 25 years old 
2. Presented with at least 2 episodes of self-harm lifetime, with at least 1 of these in the past 
month OR 5 episodes of self-harm in the past year (based on NSSI Disorder criteria in the 
DSM-5) and currently reporting self-harm urges or difficulties stopping 
3. Have a smartphone  
4. Can commit to attending 3 consecutive weekly FIT sessions, and 5 follow-up telephone 
sessions, and assessments over follow up period as required by the study 
5. Have adequate English language ability to permit the assessment and experimental 
measures to be completed, and use the smartphone app 
6. Willing to consent to receive support to reduce / improve management of self-harm urges 
and behaviour; in person or by video, and over the phone and via smartphone app  
7. If 12 – 15 years old, willing for parent/guardian to provide consent to study participation 
8. Willing to have letters sent/phone calls made to relevant clinicians  
9. Resident within geographical areas covered by West London NHS Trust.  
 
Exclusion Criteria 
 
The participant may not enter the study if any of the following apply: 
 
1. Severe learning disability or pervasive developmental disorder 
2. Current acute psychotic episode 
3. Current substance dependence 

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4. Imminent risk of suicide or harm to others (based on clinicians’ risk assessment, see 
Section 4.1) 
5. Insufficient English language fluency to complete study outcome measures 
6. Taking part in concurrent treatment studies investigating pharmacological or 
psychological treatment for self-harm 
7. Unwilling to engage actively in the FIT intervention or to use an imagery-focused 
approach for treatment 
8. Unwilling to use a smartphone app. 
 
2.7 PROCEDURES 
 
Overview of procedures 
 
1. Baseline Screening Visit (1hr total): 
• consent taking: 20 mins 
• collection of baseline measures: 40 mins 
 
2. FIT intervention sessions (3hrs total): 
• 3 sessions: max 1 hour each 
 
3. Follow up support phone sessions (1hr 30mins total): 
• first session: 30 mins 
• sessions two to five: 15 mins  
 
4. Outcome Assessments (1hr 30mins total): 
 
• Post intervention via video-call/in person (as preferred) with researcher: 45 mins 
• 6 months follow-up (3 months after intervention) via video-call/in person (as preferred) with 
researcher: 45 mins 
 
5. Patient’s feedback interview: 1 hour total 
 
The total duration of contact with the research team and time involved in research activities will 
be approximately 7 hours for all participants and 8 hours for participants also undertaking the 
feedback interview, over approximately six months. 
 
Recruitment 
 
Participants will be recruited into the study from any team across WLT, including CCAMHS and 
MINT teams.  
 
Referrals into WLT CCAMHS and MINT mostly come from GPs, schools and the Single Point of 
Access line and are discussed in daily/weekly referrals meetings. Outcomes include: offering low-

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intensity psychological interventions (for adolescents, CBT based Guided Self-help, GSH, for low 
mood or anxiety delivered by CWPs; for adults, group interventions such as Emotion Regulation 
Skills groups delivered by CAPTs); further consultation to assess need/suitability for a high 
intensity psychological intervention (e.g. for adolescents mainly CBT or family therapy, for adults 
DBT or trauma-focused therapy); in particular for adults, medication review etc. When referral 
information is insufficient, a further triage call is conducted by a clinician to get more information 
from the referrer, young person, parent/carer, or school. This often includes information about 
history of self-harm and other risks.  
 
YP referred into WLT teams, including CCAMHS/MINT will be pre-screened for eligibility to 
participate in the IMAGINATOR study as part of this routine referrals discussion and triage 
process. YP presenting with current self-harm that is deemed suitable for a low-intensity 
intervention (based on the teams' clinical judgment) will be asked by a member of the clinical 
team if they would like to find out more about the IMAGINATOR study, alongside a plan part of 
routine care. This will include YP accepted on the wait list for another high intensity intervention 
(e.g. in CCAMHS wait list time approx. 1 year, in MINT wait list for DBT approx. 6 months) or YP 
offered a low-intensity intervention (e.g. in CCAMHS, wait list for GSH for low mood/anxiety 
delivered by CWPs approx. 4 weeks; in MINT wait list for low-intensity groups approx. 1 month). 
YP who are offered a low-intensity psychological intervention as well as invited to take part in 
the IMAGINATOR study will be able to choose whether to take part in IMAGINATOR before or 
after the other intervention.  
 
Flyers will also be distributed in WLT waiting rooms and Drs’ offices. Young people who would 
like to find out more, can then contact the research team directly or speak to their clinician who 
will then contact the research team. YP recruited in this way will receive the IMAGINATOR 
intervention from a therapist in WLT depending on their age and location.  
 
Following the above, YP (or their parent/guardian if < 16 year old) who i) are interested in taking 
part in the study and ii) express verbal consent for the clinician to share their contact details with 
the research team, will be contacted by the research team (Imperial College researchers). 
Alternatively, YP aged >16 years old who are screened as suitable and potentially benefitted by 
the intervention by their clinical team are contacted directly by the WLT Research Assistants who 
are embedded in the clinical teams and regularly attend referrals and multidisciplinary team 
meetings. Potential participants (or their parent/guardian if < 16 year old) will be sent the Short 
Participant Information Sheet by email and provided a brief introduction to the study (via email 
or phone as preferred) and asked if they would like to arrange a Baseline Screening Visit. If they 
agree, a video/in person appointment will be arranged and the Full PIS will be emailed to the YP 
(and parent/carer where needed). 
 
The above procedures ensure that participation in the study is additional to and does not replace 
the participants’ routine primary and/or mental health care, i.e. the FIT intervention is to be 
considered as an additional intervention to standard care as provided in the WLT, in line with 

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best practice NHS standards. Risk management continues to be delivered as per routine WLT 
procedures and guidelines, by the participant’s WLT team. 
 
Baseline Screening Visit 
 
The screening visit will be conducted in person or online via Imperial Zoom, as preferred by 
participants, lasts approximately 1 hour and includes the following procedures: 
 
Informed Consent: Participants are provided with a further copy of the PIS if needed and asked 
if they have any outstanding questions. The researcher goes through the study information 
verbally with participants. If the participant remains interested in the study, informed consent is 
then taken prior to commencing the eligibility assessment by sending a link to an online consent 
form on Qualtrics. Informed consent is taken by trained researchers. Informed consent also 
includes: consent to risk management procedures (see IMAGINATOR Study Risk Assessment 
Procedures, Section 4.1) and to anonymised data sharing policies (see Section 4.4). The consent 
form is downloaded from Qualtrics as a pdf, signed by the researcher, and then a copy is emailed 
to the participant.  
 
For participants aged <16 years old, parental consent is sought alongside participant’s assent 
using the same procedures outline above. Once parental consent has been obtained, participants 
will decide if they prefer their parent to be present for the remaining of the assessment or not.  
 
Collection of Baseline Measures: Eligible participants are then asked to complete further 
baseline questionnaires and interviews (see 3.7 Assessments and Questionnaires) assessing: the 
presence, characteristics and frequency of self-harming behaviour; demographic characteristics; 
measures of clinical and functional outcomes; and measures of characteristics and processes 
associated with self-harm and with FIT (e.g. mental imagery characteristics). All questionnaires 
are standard tools, which are commonly used in psychological studies. Specially designed 
measures for this study are: the Timeline Follow Back Technique to assess self-harm frequency; 
the Two items questionnaire on self-harm severity; and the Self-Harm Imagery Interview (see 
Section 3.7). All measures will be collected using Qualtrics, either on the researcher’s laptop if in 
person, or by sending the participant links to the questionnaires via the Imperial Zoom chat.  
 
At the end of the Baseline Screening Visit, the researcher will ask the participant if they have any 
further questions about the study or therapy sessions, and check that the participant feels ok 
before ending the visit. If the participant is upset for any reason, the researcher will follow risk 
assessment procedures outlined in section 4.1 Risks and Benefits, and contact the duty clinician 
when necessary. The researcher will inform the participant that the therapist will contact them 
within 2 weeks to book in the first therapy session. 
 
Finally, the researcher shares the baseline RCADS/DASS-21 measure with the therapist, CWP or 
CAPT, who then administer the RCADS (most salient subscale/s) or DASS-21, as applicable, at 
each therapy session to track symptoms.  
 

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Informing Clinicians of Young Person’s Participation 
 
A standard email informing of their taking part in the study is sent by the research team to the 
lead clinician involved in their routine care named by the participant, and the participant's 
referrer into the study (if applicable and different from the above). 
 
Intervention Phase 
 
Functional Imagery Training (FIT): Functional Imagery Training comprises of three elements: a) 
formulation of idiosyncratic drivers of self-harming behaviour and reasons for change; b) 
motivational interviewing combined with mental imagery techniques that enhance motivation to 
change the self-harm dysfunctional habit; c) formulation of goals for change (i.e. the goal is a 
desired behaviour alternative to self-harm) and practice of functional imagery to support goal 
achievement. 
 
The first FIT session focuses on formulating idiosyncratic drivers of self-harm behaviour and 
personal motives for change, and using motivational interviewing with embedded mental 
imagery practice. This includes identifying risky situations for self-harm, triggers, recurrent 
emotional responses and associated cognitions including cognitions in the form of images. By 
discussing mental images that may accompany self-harm behaviour, participants are familiarised 
with the concept of mental imagery and how mental images can drive emotions and behaviour. 
A first exploration of pros and cons of self-harm behaviour is carried out, and of the reasons 
supporting each participant’s desire to change. An individualised formulation of the patient’s 
current problem is discussed and drawn out as a diagram, which identifies a “target” for change 
that could be the focus of treatment. This formulation is then reviewed at the beginning of the 
first FIT sessions. For example, if a participant identifies that their most prevalent driver of self-
harm is the need to gain control over anxiety, the target of the intervention will be to develop 
and plan an alternative response to gain control over anxiety and advantages of achieving this 
without self-harming.  
 
After reviewing their formulation of drivers for self-harm and motives to change, participants are 
encouraged to identify in detail advantages of reducing self-harm. For example, they are asked 
to recall and visualise memories of occasions when they didn’t self-harm and associated positive 
aspects, and to imagine future short-term and long-term scenarios of successful goal 
achievement (e.g. “how I would be in a year’s time if I stopped self-harming”). Mental imagery is 
used to simulate positive aspects of behavioural change and thus support motivation for change. 
At the end of the session participants are asked to commit to the change by completing a 
homework task that consists of taking a photo of something that represents their target or goal 
for change.  
 
In this session, the young person will also identify other key goals they want to work towards in 
the therapy and record these using a ‘goals measure’. Progress in working towards these goals 
will then be reviewed and measured in the following sessions. 

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The second FIT session focuses on developing a plan of an alternative behaviour to self-harm and 
on functional imagery training to support this goal. In this session the goal is made concrete and 
translated into a short-term plan, i.e. something to be done in the next few days / week as an 
alternative to self-harming (e.g. “what I will do tomorrow to achieve my goal of managing anxiety 
without self-harming). Obstacles to change are discussed together with planning strategies to 
overcome them. Once a plan is outlined, participants are guided to practice it from beginning to 
end using mental imagery and are trained to harness mental imagery characteristics (e.g. 
vividness, realness) so that the imagery simulation amplifies motivation and drive to put in place 
the desired behaviour (e.g. “when I feel anxious, going for a short walk”).  
 
At the end of the second FIT session, participants download the IMAGINATOR app on their 
smartphone and are instructed on the app use to support practicing the functional imagery 
developed in session (see below). Finally, the first support call is scheduled in one week time. 
 
The third FIT session focuses on discussing how practicing the functional imagery went, and 
problem-solving ways to improve the imagery plan. The therapist will work with the young person 
to fine tune the imagery, to help enhance any beneficial effects the imagery may have on emotion 
regulation. 
 
To assess risk and adverse events, at the beginning of each session the therapist conducts the 
Columbia-Suicide Severity Rating Scale (C-SSRS) interview. 
 
Follow-up Phase 
 
Follow up and support sessions: The Follow Up phase involves five support phone calls by the 
therapist/CWP/CAPT who conducted the FIT. The first phone support takes place one week after 
the second FIT session (approx. 30 mins duration). This session focuses on refining the functional 
imagery practice and problem-solving obstacles to training the imagery techniques. Suggestions 
- aim to incorporate the IMAGINATOR app as much as possible if the participant feels this is 
useful, for example discussing how the different app functionalities can be used, personalised 
and maximised to support the FIT.  
 
Four further phone support sessions (approx. 15 mins each) are then delivered fortnightly, which 
focus on further problem-solving, motivational encouragement and discussion of how to 
maximise the IMAGINATOR app use.    
 
To assess risk and adverse events, the therapist will conduct a clinical risk assessment at the 
beginning of each phone session.  
 
IMAGINATOR app-based support: The IMAGINATOR app was co-designed with YP with lived 
experience of self-harm (see 2.2. Co-production). It is used by participants as a support to keep 
practicing and training FIT to achieve their behavioural change goal during the study follow-up 

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phase. The IMAGINATOR app does not introduce any new element from what has been discussed 
and developed in the FIT face-to-face sessions and is neither intended to nor designed to be used 
as a self-standing tool. To ensure confidentiality, the IMAGINATOR app makes no reference to 
self-harm and all push-ups and notifications only refer to ‘IMAGINATOR’. 
 
Routine follow-up: The therapist/CWP/CAPT) will follow up routinely with the young person at 
16 – 18 weeks. 
 
Outcome Assessments (post intervention and 6 months follow-up) 
 
All participants complete outcome assessments post intervention (the week after the final 
telephone session) and at 6 months follow-up from intervention start (3 months after the end of 
the intervention). Outcome assessments are completed via video-call or in person depending on 
the participant’s preference. Measures are collected using Qualtrics (see 3.7 Assessments and 
Questionnaires for measures). The participant completes the questionnaires on the researcher’s 
laptop if in person, or by a link to the questionnaires sent through the Imperial Zoom chat.  
  
The outcome measure of Emergency Department attendance following a self-harm episode will 
be collected via access to routine clinical records of West London NHS Trust where entries by 
Liaison Psychiatry clinicians are reported following Emergency Department assessments on the 
North West London Whole Systems Integrated Care Dashboard (as consented by participants). 
This would include communication of assessments conducted out of area.  
 
Participant Feedback Interview (6 months follow-up) 
 
Researchers and trained YPAG members will conduct semi-structured interviews face-to-face or 
via video-call. Given our small sample-size we will seek to interview 2/3 of participants consented 
into the study until data saturation is achieved. Interview topic areas will include experience of 
the intervention and of the research procedures and motivations/barriers in accessing and using 
the IMAGINATOR intervention. We will seek to include a diverse sample in terms of socio-
demographic characteristics. A qualitative process evaluation focusing on app-usability and 
design will be conducted using an established co-production methodology (Dewa et al., 2021a, 
2021b). 
 
For the app component, interviews will explore:  
 
• 
barriers and facilitators to use;  
• 
use of imagery audios and of tracking symptoms/experiences; 
• 
expectations about future use, design and functionality suggestions; and, 
• 
ideas for implementation into different settings. 
 
Supervision Arrangements  
 

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IMAGINATOR cases will be discussed as part of therapist/CWP/CAPTs’ routine weekly individual 
case management supervision. In addition, the PI (Di Simplicio) will provide group clinical skills 
supervision focusing on the delivery of IMAGINATOR. All FIT sessions are audio recorded, which 
is routine practice in WLT for training purposes. 
 
End of Study Definition 
 
The end of study is the date when the last participant enrolled completes the last Outcome 
Assessment or Feedback Interview. It is hoped to finish collecting data by December 2022. The 
final report is planned to be prepared by January 2023. 
 
2.8 ASSESSMENTS AND QUESTIONNAIRES 
 
1) The following measures are collected during the Baseline Screening Visit and again during the 
Outcome Assessments (post intervention and at 6 months follow-up): 
 
Self-harm measures 
 
Administered by researcher: 
 
a) Self-harm frequency over the past 3 months: Using the timeline follow-back technique 
(TLFB, Sobell & Sobell, 2008). This is an interview method conducted by the researcher 
who reconstructs together with the participant the number of self-harm behaviours 
using calendar cues. It has been successfully used in previous self-harm research 
including our proof-of-concept study (Di Simplicio et al., 2020; Maschauer et al., in 
preparation). 
 
b) Self-harm severity over the past 3 months: A combined measure of a Visual Analogue 
Scale, severity criteria used in the NSSI disorder in the Diagnostic and Statistical Manual 
of Mental Disorder Fifth Edition (DSM-V, 39) and the number of different self-harm 
methods used (also termed self-harm versatility), elicited via these open questions: ‘‘In 
the last three months, how severe was the worst injury that you inflicted to yourself? Can 
you list all the ways that you have used to harm yourself in the last three months?’’ This 
method was advised by the YPAG to avoid scales listing numerous self-harm methods 
which could be triggering/enabling. 
 
c) Mental imagery related to self-harm: Using the Self-Harm Imagery Interview adapted 
from (Hales et al., 2011): This interview is about mental images that deal with self-harm 
or occur with self-harm. It asks participants to think about one of these and explores their 
thoughts and emotions in relation to the image. 
 
d) Suicidal thoughts and behaviour:  Using the Columbia-Suicide Severity Rating Scale (C-
SSRS) (Posner et al., 2011) is widely used interview for suicide risk assessment and 

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measurement of suicidal ideation and behaviour. The Lifetime/Recent version will be used 
at screening to gather recent history of suicidality including suicidal ideation and/or 
behaviour. The scale measures four constructs: severity of ideation on a 5-point ordinal 
scale (from 1=wish to be dead, to 5=suicidal intent with plan); intensity of ideation via 5 
items (e.g. frequency, duration etc.), each rated on a 5-point ordinal scale; behavior rated 
on a nominal scale (including actual, aborted, and interrupted attempts, preparatory 
behavior and non-suicidal self-injurious behavior); and lethality rated on a 6-point ordinal 
scale. This measure will additionally be used at the start of each face-to-face FIT session. 
 
e) Motivation to reduce self-harm: Using the State Motivation for Reducing Self-harm (SM-SH) scale 
(Parham et al., 2017). This scale measures participants’ motivation to control their self-harm using 
12 items that measure the strength of their motivational cognitions in the present moment, rated 
on a 10-point likert scale, from 0 (never) to 10 (constantly).  
 
Self-report: 
 
f) Urge to self-harm: Using the Craving Experience Questionnaire for Self-Harm (CEQ-SH), 
adapted from CEQ (May et al., 2014) This questionnaire assesses the urge to self-harm 
and assesses frequency, intensity, salience or dismissability of intrusive thoughts 
surrounding self-harm. It is rated on a 10 point Likert type scale ranging from not at all 
(0) to constantly (10). 
 
 
Clinical and functional measures 
 
Self-report: 
 
a) Symptoms of low mood and anxiety: using 1) the Revised Children’s Anxiety and Depression 
Scale (RCADS) for 12 – 17 year olds, is a 47 item youth self report questionnaire with six 
subscales (separation anxiety disorder, social phobia, generalised anxiety disorder, panic 
disorder, obsessive compulsive disorder, and low mood (major depressive disorder)) and a 
total anxiety scale and total internalising scale. The RCADS has good internal consistency, 
test-retrest reliability and convergent validity.  2) the Depression, Anxiety and Stress Scale 
(DASS-21) (Antony et al., 1998), for 18 – 25 year olds, a 21-item scale measuring levels of 
depression, anxiety and stress over the past week. It has acceptable to excellent internal 
consistency validated in both clinical and non-clinical samples. The depression scale 
measures symptoms associated with dysphoric mood e.g. worthlessness; the anxiety scale 
measures symptoms associated with physiological arousal such as trembling, as opposed to 
symptoms of generalised anxiety; and the stress scale measures symptoms of tension and 
reactivity to stressful events;  
 
b) Psychological wellbeing: using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) 
(Tennant et al., 2007), which consists of 14 positively worded items. Items are rated on a 5 
point likert scale ranging between none of the time (1) and all of the time (5) with five 

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response categories and assesses mental wellbeing covering both hedonic and eudemonic 
perspectives. 
 
c) Emotion regulation abilities: using the Difficulties in Emotion Regulation Scale-Short Form 
(Kaufman et al., 2016), an 18-item scale adapted from the original long version that measures 
general emotion regulation ability as well as various aspects of emotion regulation (in six 
subscales), e.g. difficulties engaging in goal directed behaviour when upset, and limited 
access to emotion regulation strategies. The scale has high internal consistency.  
 
d) Engagement in other risky, self-destructive behaviours (e.g., binge eating, substance 
misuse): using the 11-item behaviour supplement to the Borderline Symptom List (Bohus et 
al., 2001). The scale has high internal validity and test-retest reliability. 
 
e) Alcohol misuse/dependence: Alcohol Use Disorders Identification Test (AUDIT) (Saunders et 
al., 1993) This is a 10-item measure of alcohol misuse and possible dependence, in which 
participants are asked to rate items related to their drinking (e.g. ‘How often do you have a 
drink containing alcohol’) on a 5-point scale. The AUDIT is an effective means of identifying 
hazardous or harmful drinking behaviour.  
 
f) 
Cannabis misuse/dependence: Cannabis Use Disorder Identification Test Revised (CUDIT-R) 
(Adamson et al., 2010) This measure is used to screen for problem cannabis use. Participants 
are asked to rate a series of eight items relating to their cannabis use (e.g. ‘How often do you 
use cannabis’) on a 5-point likert scale.  The measure has excellent internal consistency.   
 
g) Anhedonia:  Anhedonia Scale for Adolescents (ASA) (Watson et al., 2021) is designed for use 
in 11-18 year olds and measures anhedonia on a 4 point likert scale using 15 questions. The 
ASA has high test-retest reliability. Temporal Experience of Pleasure Scale (TEPS) (Gard et al., 
2006) captures a trait disposition to anticipation and consummation of pleasure using 18 
items and a 6 point likert scale. The TEPS is internally consistent and temporally stable.  
 
 
3) The following measures are collected once the intervention has started: 
 
Acceptability measures 
a) Credibility/Expectancy Questionnaire (Devilly & Borkovec, 2000), is a short questionnaire 
measuring cognitively based credibility and affectively based expectancy of the therapy. 
The questionnaire has high internal consistency and good test-retest reliability. This will 
be used after the first face-to-face session.  
 
b) Client Satisfaction Questionnaire – 8 item version (Attkisson & Zwick, 1982), provides a 
sensitive and comprehensive measure of patient satisfaction with the therapy received. 
This will be used post-treatment. 

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c) User Experience Questionnaire (Laugwitz et al., 2008), assessed post-treatment (see 
Section 2.6 for details) 
 
d) Imaginator Feedback Questionnaire, administered post-treatment to obtain written 
feedback on the Imaginator intervention.  
 
e) Adverse events will be recorded at each assessment and therapy session/phone call 
contact. 
 
Usability of the app 
 
Engagement metrics will be collected directly from the app, including: 
a) Time to first access the app 
b) Total number of times accessed 
c) Total number of days/weeks the app accessed on 
d) Number of times used per week 
e) Duration of use per functionality. 
 
Factors associated with app engagement: 
a) Questions relating to socioeconomic status, such as approximate yearly personal or 
parental income. 
b) Questions relating to technology/digital skills. 
 
Feasibility and adherence to therapy protocol 
 
An indication of feasibility will be assessed by calculating treatment adherence indicators, such 
as: 
a) Average number of therapy sessions completed by participants 
b) Percentage of participants completing different components of the intervention (face-to-
face sessions, phone calls) 
c) Attrition (the percentage who complete post-intervention assessment). 
d) Adherence to therapy protocol by therapists will be checked on a random sample of 
therapy session recordings against the therapy session checklist (part of the Imaginator 
manual). 
 
Qualitative assessments 
 
a) Semi-structured interview schedule developed using an established co-production 
methodology (Dewa et al., 2021a, 2021b), and used by the research team and YPAG 
during follow up interviews. 
 

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2.9 DATA ANALYSIS 
 
Sample Size 
 
We aim to reach N=15 participants who will complete treatment and 6 months follow-up 
assessments. Based on an expected 25% attrition rate from our previous study (Di Simplicio et 
al., 2020), N=20 participants will be enrolled in the study. 
 
 
Statistical Analysis 
 
Quantitative data will be summarised into descriptive statistics such as means, medians, inter 
quartile range, standard deviations for all measures and percentage change and Cohen’s d for 
the clinical outcomes repeated at pre- and post-intervention. Qualitative data will be analysed 
using a co-produced thematic analysis approach based on Braun & Clarke (2006) and Dewa et 
al. (2021a, 2021b). Data and all appropriate documentation will be stored for a minimum of 10 
years after the completion of the study, including the follow-up period.   
 
  
3. ETHICS 
 
3.1 ETHICS APPROVAL 
The Study Coordination Centre has obtained approval from the West of Scotland Research Ethics 
Committee (REC) 5 and Health Research Authority (HRA). The study must also receive 
confirmation of capacity and capability from each participating NHS Trust before accepting 
participants into the study or any research activity is carried out. The study will be conducted in 
accordance with the recommendations for physicians involved in research on human subjects 
adopted by the 18th World Medical Assembly, Helsinki 1964 and later revisions. 
 
3.2 RISKS AND BENEFITS 
 
Risks: There are only low foreseeable serious risks associated with this project. The treatment 
protocol of FIT is in keeping with NICE guidelines and current psychological interventions for self-
harming behaviour. Elements included in FIT such as motivational interviewing, formulation of 
drivers of self-harm and use of mental imagery techniques for targeting self-harm are part of 
established psychological therapies such as cognitive-behavioural therapy, dialectical-
behavioural therapy and schema therapy commonly used for individuals who self-harm. Our 
previous study using this protocol reported no adverse events (Di Simplicio et al., 2020). 
 
Participants’ wellbeing and safety will be taken into account as a priority concern at all points in 
the study. 
 

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However, theoretically it is possible that a number of procedures (listed below) included in the 
study may result in causing increased levels of distress. If this would be the case the necessary 
steps to guarantee the participant’s wellbeing and safety will be taken as described below. 
 
Study procedures that ask to recall information about current and past psychological problems 
and/or current and past problematic experiences may result in (i) i.e. increased perceived distress 
and/or (ii) i.e. disclosure of information relevant for the participants’ mental health and safety. 
These include: 
 
• responding to questionnaires during the Baseline Screening Visit and the Outcome 
Assessments (see 3.6 and 3.7); 
• answering questions that investigate details of self-harm behaviour and associated 
emotions during the FIT sessions and during the follow up phone support sessions (see 3.6). 
 
The risk (i), i.e. of major distress being caused by the above study procedures will be minimised 
in three major ways: 
 
Firstly, participants will be fully informed about the content of the outcome assessments (such 
as questionnaires including questions about mood, self-harm behaviour, alcohol and drug use) 
so that they can prepare themselves and give fully informed consent to participate. Equally, they 
will be fully informed and prepared with regards to the contents and procedures of the FIT 
intervention. Research has demonstrated that asking about self-harming behaviors does not 
increase risk of harmful outcomes (Polihronis et al., 2020) but instead may in fact give participants 
an opportunity to contribute to research and to “tell their story” (Biddle et al., 2013).  
 
Secondly, all researchers conducting eligibility assessment at the baseline screening visit will be 
trained and supervised by expert clinicians who will also provide cover at the time of the 
assessments (‘duty clinicians’).  
 
The study therapists are qualified CWP/CAPTs or other clinicians (e.g. medical doctor) who are 
trained to deliver GSH interventions to YP with low mood or anxiety. They are used to discussing 
upsetting experiences with YP in a way that is collaborative, puts the young person at ease and 
is perceived as useful and necessary for aiding symptoms resolution by both therapist and 
patient. Moreover, these clinicians are well equipped to make sure that any distressing session 
ends by the participant feeling supported and endowed with the necessary coping strategies in 
place to go safely back to their home environment. 
 
Case management supervision for the therapists/CWPs/CAPTs will be provided through routine 
weekly individual sessions with their supervisors and group clinical skills supervision will be 
provided the study therapist. 
 
Therapists/CWPs/CAPTs and researchers will always remain sensitive to signs of participant 
distress and will terminate the assessment or specific intervention, or the session itself, if the 
participant becomes distressed and wants to stop. In our experience, it is rarely, if ever necessary 

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that clinical interviews are interrupted, as participants are aware of what the interviews will 
entail and are readily able to answer the questions they contain. Researchers will also check the 
participant’s mood state and safety upon completion of the self-report questionnaires during the 
Baseline Screening and Outcome Assessments Visits.  
 
The risk (ii) i.e. of disclosing information that is relevant to the participant’s safety and health, 
such as a mood state that meets criteria for a tier 3 intervention (e.g., psychosis or eating 
disorder), or the presence of suicidal risk, will be addressed by putting in place the following 
series of procedures that will ensure the participant is safe and their mental state is taken into 
account: 
 
• Review confidentiality with young person 
• Supportively assess risk (in terms of safeguarding or clinical risk) 
• Carry out all possible interventions to reassure, support, reduce active distress to the 
minimum possible once this has become apparent; 
• Agree with the participant on a strategy to ensure their needs, in terms of mental state and 
safety, are met as soon as possible. This is likely to include informing other individuals such 
as family, friends, and other mental health workers or clinicians; 
• Therapists/CWP/CAPT will inform senior colleagues (e.g., their supervisor, duty clinician) 
immediately and follow their advice. This may involve liaison with the local CAMHS or adult 
Crisis Team.  
 
If risk is disclosed during a FIT therapy session or phone support session, the CWP/CAPT/therapist 
will directly proceed as per points above. 
 
If risk is disclosed during the Baseline Screening Visit or during the Outcome Assessments, 
interview run by a researcher or YPAG member, they will follow the IMAGINATOR study Risk 
Assessment Procedures: this details when and how they will immediately alert the duty clinician 
who will ensure the participant is safe and their mental state is taken care of as per points above.  
  
Participants will be informed and will have consented to this set of procedures prior to the 
beginning the Baseline Screening Visit.  
 
In addition to the regular professional skills development and supervision attended by the 
therapists/CWPs/CAPTs, quality of FIT intervention delivery is also provided by routine specific 
clinical supervision during the course of the study by Dr Martina Di Simplicio (CI) and Dr Ben 
Aveyard. This allows individual case discussion, ensures therapist’s adherence to the intervention 
protocol and maintains high quality levels in treatment delivery throughout the study. Dr Di 
Simplicio and Dr Aveyard are a Honorary Consultant Psychiatrist and a Highly Specialist Clinical 
Psychologist, respectively, in West London NHS Trust and are up to date with mandatory training 
and Trust procedures for risk assessment and management. 
 

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Benefits: Participants have the opportunity to participate in a clinical research study which 
can be interesting and which may enable them to feel that they are helping others and that 
some benefit may come from their difficult experiences. Participants also have the 
opportunity to experience a treatment intervention that may prove beneficial for the 
improvement or resolution of symptoms that they are experiencing. This is particularly 
relevant as immediate intervention for reduction of self-harming behaviour is currently 
lacking in the local West London NHS Trust services. Participants will receive a support tool, 
such as the IMAGINATOR app, to be used also after study completion.  
 
3.3 ADVERSE EVENTS  
 
Definitions 
 
Adverse Event (AE): any untoward medical occurrence in a patient or clinical study subject.   
 
Serious Adverse Event (SAE): any untoward medical occurrence or effect that: 
• 
Results in death 
• 
Is life-threatening – refers to an event in which the subject was at risk of death at 
the time of the event; it does not refer to an event which hypothetically might have 
caused death if it were more severe 
• 
Requires hospitalisation, or prolongation of existing inpatients’ hospitalisation 
• 
Results in persistent or significant disability or incapacity 
• 
Is a congenital anomaly or birth defect 
 
Medical judgement will be exercised in deciding whether an AE is serious in other situations.  
Important AEs that are not immediately life-threatening or do not result in death or 
hospitalisation but may jeopardise the subject or may require intervention to prevent one of the 
other outcomes listed in the definition above, will also be considered serious. 
 
Reporting Procedures 
 
All adverse events will be reported.  Depending on the nature of the event the reporting 
procedures below will be followed.  Any questions concerning adverse event reporting will be 
directed to the Chief Investigator in the first instance.   
 
Non serious Aes: All such events, whether expected or not, will be recorded- it will be specified 
if only some non-serious Aes will be recorded, any reporting will be consistent with the purpose 
of the trial end points.  
 
Serious Aes: An SAE form will be completed and emailed to the Chief Investigator within 24 
hours.  However, hospitalisations for elective treatment of a pre-existing condition will not need 
to be reported as SAEs.  
 

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All SAEs will be reported to the West of Scotland REC 5 where in the opinion of the Chief 
Investigator, the event was: 
• 
‘related’, ie resulted from the administration of any of the research procedures; and 
• 
‘unexpected’, ie an event that is not listed in the protocol as an expected occurrence 
 
Reports of related and unexpected SAEs will be submitted within 15 days of the Chief Investigator 
becoming aware of the event, using the NRES SAE form for non-IMP studies.  The Chief 
Investigator will also notify the Sponsor of all related and unexpected SAEs. 
 
Local investigators will report any SAEs as required by their Local Research Ethics Committee, 
Sponsor and/or Research & Development Office. 
 
Contact details for reporting SAEs 
RGIT@imperial.ac.uk 
CI email (and contact details below) 
Email: m.di-simplicio@imperial.ac.uk 
Please send SAE forms to: m.di-simplicio@imperial.ac.uk 
Tel: 07512646698 (Mon to Fri 09.00 – 17.00) 
 
 
3.4 INFORMED CONSENT 
 
Consent to enter the study will be sought from each participant (and parents / legal guardians 
where appropriate) only after a full explanation has been given, an information leaflet offered 
and time allowed for consideration.  Signed participant consent will be obtained.  The right of the 
participant to refuse to participate without giving reasons will always be respected.  After the 
participant has entered the study the clinician remains free to give alternative treatment to that 
specified in the protocol at any stage if he/she feels it is in the participant’s best interest, but the 
reasons for doing so should be recorded.  In these cases the participants remain within the study 
for the purposes of follow-up and data analysis.  All participants will be free to withdraw at any 
time from the protocol treatment without giving reasons and without prejudicing further 
treatment. 
 
Written Informed Consent is obtained in accordance with MHRA guidance (Joint Statement on 
Seeking Consent by Electronic Methods v1.2 September 2018), while the researcher is in person 
or on video-call with the participant, by means of a dated digital signature on an online consent 
form (see below for links to forms). After the participant has completed the consent form, the 
researcher taking consent will download a pdf copy of the consent form and add their digital 
signature. The consent form, signed by both participant and researcher, is then emailed to the 
participant. An encrypted copy will be stored on a secure computer drive at Imperial College 
London. For participants who are <16, participant assent is sought alongside parent/guardian 
consent, and the assent and consent forms are handled using the same procedures outlined 
above. 

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Consent and Assent Forms: 
 
Consent Form (participants aged 16 – 25): 
https://imperial.eu.qualtrics.com/jfe/form/SV_a5HceLkfT7hf68C 
 
Assent Form (participants aged 12 – 15): 
https://imperial.eu.qualtrics.com/jfe/form/SV_cO3z5scFZxHhdps 
 
Parent/Guardian Consent Form (participants aged 12 – 15): 
https://imperial.eu.qualtrics.com/jfe/form/SV_1X1bCl1PL9ugf9Y 
 
3.5 DATA MANAGEMENT AND PARTICIPANT CONFIDENTIALITY 
 
The Chief Investigator will preserve the confidentiality of participants taking part in the study and 
is registered under the Data Protection Act. 
 
The following documents and data will be collected during the study: 
 
• Digital consent/assent forms 
• Participant questionnaires and structured interviews collected via Qualtrics 
• Participants’ attendance to the Emergency Departments (ED) over the duration of the 
study, collected by researchers on the team who have regular access to WLT clinical 
records in their clinical capacity (Di Simplicio, Aveyard, Gardner-Bougard).  
• Digital recordings of co-design workshops and interviews, and transcripts of co-design 
workshops and interviews. 
 
Data will be pseudonymised. A study specific participant ID number will identify the participant 
on questionnaires and structured interviews collected via Qualtrics, transcripts and ED 
attendance. The name and any other identifying detail will not be included in any study electronic 
database compiled for the purpose of statistical analysis of the research outcomes. Electronic 
data will be stored on network drives and encrypted discs held at the study site. A document 
matching identity and login number is centrally managed by the research team and only accessed 
by named research team members.  
 
Digital recordings from co-design workshops and interviews will be stored in encrypted network 
drives at the study site. Transcripts from the recordings will be pseudonymised and data will be 
processed and stored in separate encrypted network drives.  
 
Data from the app will be transferred to Amazon Web Services. We will apply established 
approaches for ensuring maximum data security on the IMAGINATOR app. The data protection 
procedures will be the same as those approved for a wide range of control and clinical studies in 
the UK and in countries around the globe (e.g., 17IC4009). In brief, app data (imagery, mood 

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ratings, app use) will be transferred directly from the app and collected on a remote web server, 
using Amazon Web Services (specifically, the London based eu-west-2 datacentre). Remote 
storage of these data will be in pseudonymised format and will be linked to the Qualtrics 
collected data using the same pseudonymised numerical user identifier codes. Email addresses 
to login in the app will be stored alongside user passwords and anonymous codes in a separate 
database ‘key’. The database is encrypted and password protected. The servers are behind a 
firewall in the secure Amazon cloud computing facility described above. These measures 
represent a high-level of data security that are the standard for any app that requires users to 
login and enter potentially sensitive information. Study investigators will be the only users who 
can download datasets describing the entire sample via two-factor authentication. Only the 
database administrator (CoI Hampshire, Imperial College London) and PI will have access to 
database that holds the email address key. As part of the app design process, we will explore if 
direct data communication from the app to the therapist would be compliant with the above 
data security principles.  
 
The study will comply with the Data Protection Act 2018, which requires data to be anonymised 
as soon as it is practical to do so. Participants’ confidentiality is only breached in case of disclosure 
of information relevant to their health and safety, in which case this will be communicated to an 
indicated health professional (as detailed above). 
 
All documents are stored securely and only accessible by study staff and authorised personnel. 
The data will be stored in compliance with GDPR guidelines. Data will be stored for a period of at 
least 10 years after the date of publication of results in accordance with the minimum standard 
for journal publications as outlined in the British Psychological Society Good Practice Guidelines 
for the Conduct of Psychological Research in the NHS, and the American Psychological 
Association Publication Manual (fifth edition). During the time of storage Dr Martina Di Simplicio 
will be custodian for the data, and it will be stored using appropriate data archive facilities 
provided by the Division of Psychiatry. Named researchers will have sole access to the data over 
this time period.  
 
Dr Martina Di Simplicio, Ms Rachel Rodrigues and other named researchers, will undertake 
analysis of the data from the study. This analysis will take place at the Division of Psychiatry, 
Imperial College London and will be supported by the research centre experts in statistical and 
qualitative data analysis methods.  
 
Anonymised data (quantitative and qualitative) may be made available to other researchers 
after the end of the study upon request. 
 
4. FINANCE, INSURANCE AND AUDIT 
 

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4.1 INDEMNITY 
 
Imperial College London holds negligent harm and non-negligent harm insurance policies which 
apply to this study. 
 
4.2 SPONSOR  
 
Imperial College London will act as the main Sponsor for this study.  Delegated responsibilities 
will be assigned to the NHS trusts taking part in this study.   
 
4.3 FUNDING  
 
NIHI i4i are funding this study.  Participants will be reimbursed for their time with £10 per hour 
for the outcome assessments and feedback interview, but will not receive any reimbursement 
for the therapy (face to face or phone calls).  
 
4.4 AUDITS   
 
The study may be subject to audit by Imperial College London under their remit as sponsor and 
other regulatory bodies to ensure adherence to GCP and the UK Policy Frame Work for Health 
and Social Care Research.  
 
5. PUBLICATION POLICY 
 
The study will follow NIHR’s policy on publications (see general policy for publications link below), 
including their open access policy (link below). The open access policy states articles must be 
immediately, freely and openly accessible to all, freely discoverable, and that the NIHR will pay 
reasonable fees to enable immediate open access. 
 
General policy for publications: https://www.nihr.ac.uk/documents/nihr-research-outputs-and-
publications-guidance/12250 
 
Open access policy: https://www.nihr.ac.uk/documents/nihr-open-access-policy/28999  
 
 
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