Investigating the Effects of a Psychedelic-augmented Mental Imagery-based Intervention for Young People With Self-harm Behaviour: an Experimental Medicine Study
Phase: EARLY_PHASE1
Conditions: Self Harm
Sponsor: Imperial College London

 
 
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PsiloIMAGINE 
 
Investigating the effects of a psychedelic-augmented mental 
imagery-based intervention for young people with self-harm 
behaviour: an experimental medicine study 
 
 
 
Version 1.1, 12.06.2024 
 
 
Sponsor:  
Imperial College London 
Funder: 
ESRC 
Study 
Coordination 
Centre: 
Division of Psychiatry, Imperial College London, Hammersmith 
Campus 
    IRAS Project ID: 
330839 
 REC reference: 
xxx 
 
          
 
 
 
Protocol authorised by: 
 
Name & Role 
Date 
Signature 
 
 
 
 

 
 
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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 
 
Co-Investigators:  
Ms Ioanna Artemis Vamvakopoulou 
Professor David Nutt 
Dr Bhavika Dulab 
Dr Balasubramian Kardivelu 
Ms Sara Reed  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Sponsor  
Imperial College London is the main research Sponsor for this study. For further information 
regarding the sponsorship conditions, please contact the Head of Regulatory Compliance at: 
Research Governance and Integrity Team 
Imperial College London and Imperial College Healthcare NHS Trust 
Room 215, Level 2, Medical School Building 
Norfolk Place 
London, W2 1PG 
Tel: 0207 594 1862  
Imperial College - Research Governance and Integrity Team (RGIT) Website                        
 
 
Funder  
This study is funded by the Economic and Social Research Council (ESRC).  
 
 
This protocol describes the PsiloIMAGINE study: a psilocybin-augmented mental imagery 
intervention for young people who self-harm and provides information about procedures for 
entering participants. Every care was taken in its drafting, but corrections or amendments 
may be necessary. These will be circulated to investigators in the study. Problems relating to 
this study should be referred, in the first instance, to the Chief Investigator. 
This study will adhere to the principles outlined in the UK Policy Frame Work for Health and 
Social Care Research. It will be conducted in compliance with the protocol, the Data 
Protection Act, and other regulatory requirements as appropriate. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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TABLE OF CONTENTS 
 
KEY ABBREVIATIONS................................................................................................................. 6 
 
STUDY OVERVIEW.................................................................................................................... 8  
 
1. INTRODUCTION............................................................................................................ 9 
1.1. 
Background.................................................................................................................. 9 
1.1.1. Self-harm behaviour..................................................................................................... 9 
1.1.2. Targets for intervention in self-harm........................................................................... 9 
1.1.3. Psychedelics in therapy.............................................................................................. 10 
1.1.4. Psilocybin ................................................................................................................... 11 
1.2. 
Rationale for current study........................................................................................ 12 
 
2. OBJECTIVES................................................................................................................. 13  
2.1. 
Primary objectives...................................................................................................... 13 
2.2. 
Secondary objectives.................................................................................................. 13  
 
3. STUDY DESIGN............................................................................................................ 15 
3.1. 
Endpoints....................................................................................................................15 
3.1.1. Primary endpoints.......................................................................................................15 
3.1.2. Secondary endpoints.................................................................................................. 15  
 
4. PARTICIPANT ENTRY................................................................................................... 16 
4.1. 
Population.................................................................................................................. 16 
4.2. 
Inclusion criteria......................................................................................................... 16 
4.3. 
Exclusion criteria........................................................................................................ 16 
4.4. 
Withdrawal criteria .................................................................................................. 17 
 
5. STUDY PROCEDURES.................................................................................................. 17 
5.1. 
Recruitment............................................................................................................... 17 
5.2. 
Study Screenings and Visits........................................................................................ 17 
5.3. 
Experimental manipulation: psilocybin-augmented Imagery Re-Scripting  (ImRS).... 24  
5.4. 
Mood repair and debrief procedures......................................................................... 26 
 
6. MATERIALS ................................................................................................................. 26 
6.1. 
Experimental tasks..................................................................................................... 26 
6.2. 
Questionnaires........................................................................................................... 27 
 
7. ADVERSE EVENTS....................................................................................................... 31  
7.1. 
Definitions.................................................................................................................. 31  
7.2. 
Reporting procedures................................................................................................. 31 
7.2.1. Non-serious AEs......................................................................................................... 31 
7.2.2. Serious AEs................................................................................................................ 31 
8. STATISTICS AND DATA ANALYSIS................................................................................ 32 

 
 
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8.1. 
Sample size................................................................................................................ 32 
8.2. 
Statistical analysis....................................................................................................... 32 
8.3. 
Data storing................................................................................................................ 32 
 
9. REGULATORY ISSUES.................................................................................................. 33 
9.1.       Ethics approval........................................................................................................... 33 
9.2.       Managing risk related to psychedelics....................................................................... 33 
9.3.       Pharmacological challenge – psilocybin…........................................................................ 33 
9.4. 
Managing risk from exposure to self-harm stimuli, mental imagery of self-harm and 
       assessments of self-harm/suicide and mental health................................................ 37 
9.5. 
Benefits ...................................................................................................................... 39 
9.6. 
Participant Reimbursement…..................................................................................... 39 
9.7. 
Consent....................................................................................................................... 40 
9.8. 
Confidentiality............................................................................................................ 40 
9.9. 
Data Handling and Record Keeping............................................................................ 40 
9.10. Indemnity ................................................................................................................... 41 
9.11. Sponsor ...................................................................................................................... 41 
9.12. Funding ...................................................................................................................... 41 
9.13. Audits ........................................................................................................................ 42 
 
10. STUDY MANAGEMENT............................................................................................... 42 
 
11. PUBLICATION POLICY ................................................................................................ 42 
 
12. REFERENCES ............................................................................................................... 43 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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GLOSSARY OF ABBREVIATIONS 
AAT 
Approach/Avoidance Task 
ACE 
Adverse Childhood Experience 
AE 
Adverse Event 
ASA 
Anhedonia Scale for Adolescents 
AUDIT 
Alcohol Use Disorders Identification Test 
BP 
Blood Pressure  
CEQ 
Challenging Experience Questionnaire 
CEQ-SH 
Craving Experience for Self-Harm 
CI 
Chief Investigator 
COHS 
Creature of Habit Scale  
CRF 
Case Record Form 
CUDIT-R 
Cannabis Use Disorders Identification Test Revised 
DASS-21 
Depression Anxiety Stress Scale (21) 
DERS-SF 
Difficulty in Emotional Regulation Scale Short Form 
EBI 
Emotional Breakthrough Inventory 
ECG 
Electrocardiogram  
GP 
General Practitioner  
HR 
Heart Rate  
ICRF 
Imperial College Research Facility 
ImRS 
Imagery Re-Scripting  
MEQ 
Mystical Experience Questionnaire 
MINI 
Mini-International Neuropsychiatric Interview  
MSI-BPD 
McLean Screening Instrument for Borderline Personality Disorder 
NART 
National Adult Reading Test 
PIS 
Participant Information Sheet  
PIT 
Positive Imagery Task 
PRL 
Probabilistic Reversal Learning  
RT 
Reaction Time  

 
 
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SAE 
Serious Adverse Event 
SCS 
Self-Compassion Scale 
SH 
Self-harm 
SH-DPT 
Self-harm Dot Probe Task 
SHII 
Self-harm Images Interview 
SITBI 
Self-Injurious Thoughts and Behaviours Interview  
SM-SH 
State Motivation for reducing Self-harm Scale 
STAI-S 
State-Trait Anxiety Inventory – State 
S-UPPS-P 
Impulsive Behaviour Scale 
UDS 
Urine Drug Screen 
WIMI 
Waterloo Images and Memories Interview 
YSQ-SF 
Young Schema Questionnaire Short Form 
5-HT 
5hydroxytryptaminergic 
 
 
 
KEYWORDS 
Self-harm, psilocybin, mental imagery, imagery re-scripting, young people 
 

 
 
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STUDY SUMMARY 
 
Title: Investigating the effects of a psychedelic-augmented mental imagery-based 
intervention for young people with self-harm behaviour: an experimental medicine study 
 
Design: Double-blind placebo-controlled pharmacological enhancement experimental study  
 
Aims: To investigate if, compared to Imagery Re-Scripting (ImRS) alone, ImRS plus psilocybin 
(5-HT2A agonist) can modify psychological and cognitive processes underpinning repetitive 
self-harm behaviour in young people aged 16-25, with a focus on mental images that drive 
self-harm and associated maladaptive emotions and cognitions 
 
Outcome Measures:   
 
Primary Outcomes: 
- Frequency, vividness, compellingness, emotions’ intensity and cognitions believability 
scores on a 1-10 Likert scale related to self-harm and novel adaptive mental imagery 
- Scores on Young Schema Questionnaire Short Form (Young et al., 1994) 
 
Secondary Outcomes: 
- Performance (e.g., reaction time, accuracy) to self-harm vs neutral pictures and positive vs 
neutral pictures on the Approach Avoidance task (Loijen et al., 2020) 
- Performance (e.g., RT, accuracy, learning rate) on the Probabilistic Reversal Learning task 
(Dombrovski et al., 2010) and the Self-harm Dot Probe Task (Constantinou et al., 2010) 
- Scores on the Difficulty in Emotional Regulation Scale (Hallion et al., 2018); and the Self-
compassion scale (Neff, 2003) 
- Scores on the State Motivation for Reducing Self-harm scale (Robinson et al., 2016) 
- Scores on questionnaires related to the psychedelic experience: Mystical Experience 
questionnaire (Barrett et al., 2015), Challenging Experience questionnaire (Barrett et al., 
2016), Emotional Breakthrough inventory (EBI; Roseman et al., 2019) 
-- Feasibility outcomes: participants' recruitment rate, the retention rate for primary and 
secondary outcomes 
 
Population: Young people with a history of self-harm behaviour and experience of self-harm-
related mental imagery. 
 
Eligibility: Individuals aged 16-25 years old who experienced >=2 episodes of self-harm 
behaviour lifetime, and at least 1 in the last 4 weeks, and self-harm-related imagery in the 
last 6 weeks and have no contra-indication to taking psilocybin.  
 
Study Duration: 30 month 
 
 

 
 
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1. INTRODUCTION  
 
1.1. 
Background  
 
1.1.1. Self-harm behaviour 
Self-harm, ‘any act of self-poisoning or self-injury carried out by a person, irrespective of their 
motivation’ (www.nice.org.uk/guidance/qs34), often functions to reduce negative affect, 
increase positive affect, or gain social support (Nock & Prinstein, 2005). It is a common 
problem, with approximately 20% of young people report having self-harmed in their life 
(Gillies et al., 2018) with rates increasing (McManus et al., 2019). The incidence of self-harm 
has been conceptualised using an iceberg model, with fatal suicide at the tip, hospital 
presenting self-harm in the middle, and the greatest incidence of self-harm at the bottom 
occurring within the community and going undetected by clinical services (Geulayov et al., 
2018). Importantly, the frequency and severity of self-harm have been shown to increase over 
time (Nixon et al., 2002).  
 
1.1.2. Targets for intervention in self-harm 
Treatment innovation should be based on modifying the underlying mechanisms that 
maintain symptoms (Holmes et al., 2014), including psychological mechanisms such as 
cognition. However, little is known about the underlying cognitive processes maintaining 
repetitive self-harm behaviour, which presents a challenge for effectively targeting 
interventions.  
 
Current interventions for self-harm focus primarily on improving emotion regulation 
strategies and interpersonal skills, which helps to minimise the negative emotions often 
triggering self-harm. However, the efficacy of these interventions for reducing the number of 
young people engaging in self-harm remains mixed (Saunders & Smith, 2016).  
 
Mental imagery is the experience commonly referred to as “seeing through the mind’s eye” 
and is equal to a form of “weak perception". Across psychopathology mental imagery can 
“amplify” emotions motivation particularly when it’s vivid and compelling (i.e. encourages 
acting on its content) (Ji et al., 2019).  
 
Young people 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. Mental images of self-
harm can drive the urge to enact the behaviour and are a promising target for intervention 
(Di Simplicio et al., 2020; Hasking et al., 2018). A recent study confirmed this by using 
ecological momentary assessment for 14 days and showing that the presence of self-hrm 
imagery and predicted future urges to self-harm and the likelihood of engaging in the 
behaviour (Ji et al., 2024).  Evidence from the integrated motivational-volitional model 
indicates that self-harm is associated with deficits in setting attainable goals (O’Connor et al., 
2012) and anticipating rewarding experiences (O'Connor et al., 2008). The ability and 
motivation to engage in goals and rewarding behaviours are sustained by future positive goal-
oriented imagery, e.g., imagining going for a run and enjoying the fresh air (Kavanagh et al., 

 
 
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2005). It is possible that maintaining strong positive goal imagery can act as a protective factor 
in the motivational phase of self-harm by counteracting feelings of entrapment. Thus, 
reinforcing motivation away from self-harm and towards adaptive behaviour may represent 
a novel therapeutic approach. 
 
Imagery Re-Scripting (ImRS) is a well-established cognitive technique used across disorders 
from post-traumatic stress disorder to depression (Holmes et al., 2007). During ImRS, 
individuals bring to mind a target (‘unhelpful’) image associated with their symptoms (such 
as the ones preceding self-harm) and are guided to modify the image content in a way that 
will change the associated emotions, cognitions, and the impact on behaviour (Holmes et al., 
2007; Schaitz et al., 2020). For example, a self-harm image of a blade triggering emotions of 
relief, craving and shame and appraisals that there is no other way than self-harming to feel 
better can drive enacting the behaviour. Re-scripting can modify the image so that a friend 
appears, puts the blade away and takes the young person’s hand instead, eliciting alternative 
emotions that would stop the individual from self-harming. For example, in our pilot study 
(‘iMAGine’, IRAS: 19/SC/0275), ImRS often introduces self-compassion-themed mental 
imagery or positive goal imagery, in a personalised participant-guided way, instead of the self-
harm related image.  
 
During ImRS individuals are guided to identify maladaptive core beliefs or schemas that are 
associated with their unhelpful image and encouraged to introduce more adaptive beliefs or 
challenge the maladaptive ones via the re-scripting procedure. Such changes in maladaptive 
cognitions could weaken the association of the image with psychopathological symptoms 
(Strachan et al., 2020), i.e., self-harm behaviour. Further proposed mechanisms of ImRS focus 
on the concepts that mental imagery of salient situations can elicit the same neural response 
as the one evoked by the real experience itself (Kosslyn et al., 2001) and that imagining a 
future act can influence future behaviour (Knäuper et al., 2011).  
 
In summary, initial findings suggest that self-harm imagery is associated with engaging in self-
harm, and positive goal imagery and/or other imagery encapsulating adaptive beliefs could 
attenuate self-harm. Thus, ImRS constitutes a promising therapeutic intervention for self-
harm behaviour, as it has the potential to disrupt the emotional, cognitive, and motivational 
drive to self-harm that the self-harm image carries, and it could disrupt the underlying beliefs 
that maintain self-harm. 
 
However, emotional avoidance and fear of bringing negative images to mind can hinder full 
engagement in therapy, and deeply ingrained cognitions linked to repeated intrusive mental 
imagery may require several therapy sessions to become malleable or may resurface after 
therapy ends.  
 
1.1.3. Psychedelics in therapy 
Psychedelic-assisted therapy has shown the potential to produce dramatic psychological 
change across a number of mental disorders and improve wellbeing (Roseman et al., 2018). 
Psychedelics, including psilocybin, have been shown to facilitate confronting difficult 
emotions, which underpins their treatment effect, e.g., in depression, and report feeling more 

 
 
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emotionally re-connected and accepting (Goodwin et al., 2022; Roseman et al., 2018). 
Following psilocybin therapy, increased trait openness has been observed, reflecting an active 
approach of individuals to try novel ways of doing things, new experiences, or to consider 
other people’s opinions and world views (Erritzoe et al., 2018). Cognitive flexibility, the 
capacity to shift between different mental states, has also been shown to increase following 
psilocybin therapy for major depressive disorder, possibility opening a window of plasticity 
that could facilitate psychological interventions (Doss et al., 2021).  
 
Further, psilocybin has been shown to modulate neural activity in brain areas part of the core 
mental imagery network (Hassabis et al., 2007), suggesting synergistic mechanisms to be 
exploited. Based on this evidence, we propose that psychedelics could facilitate access to and 
re-scripting of dysfunctional mental imagery and consolidate change in the cognitive 
processes maintaining self-harm.  
 
Here we propose an acute pharmacological augmentation of a psychological intervention 
(ImRS) approach where psilocybin will be acting as a mechanistic therapeutic enhancer to 
improve ImRS outcomes (Nord et al., 2023).  
 
1.1.4. Psilocybin 
Psilocybin was used in general psychiatric research and in psychodynamic-orientated 
psychotherapy during the early to mid-1960s up until its scheduling as a controlled substance 
in 1970 in the United States, and up until the 1980s in Germany (Passie, 2005; Passie et al., 
2002). Research into the effects of psilocybin resumed in the mid-1990s, and it is currently 
the preferred compound for use in clinical research on 5hydroxytryptaminergic (5-HT) 
hallucinogens (see for example (Carter et al., 2005; Gouzoulis-Mayfrank et al., 1999; Hasler 
et al., 2004). Furthermore, clinical observations indicate that it is associated with less anxiety, 
fewer panic reactions and affective disturbances and milder vegetative side effects than other 
similar drugs (Carhart-Harris & Nutt, 2010).  
 
Psilocybin or 3[2(Dimethylamino)ethyl]1Hindol4yldihydrogenphosphate, is a tryptamine, and 
one of the major psychoactive constituents in mushrooms of the Psilocybe genus. Psilocybin 
is a high-affinity agonist of the 5HT2A receptor (Nichols, 2004). It shows good selectivity for 
this receptor over other 5HT receptors and other receptor classes. Psilocybin the highest 
affinity for the 5HT2A > 5HT1A > 5HT2C (Table 8.2.1.1.) (McKenna et al., 1990). Human 
studies showed that administering psilocybin after pre-treatment with 5HT2A receptor 
antagonist, such as ketanserin or risperidone, attenuated or completely abolished the 
subjective and perceptual effects of psilocybin (Carter et al., 2004; Vollenweider et al., 1998) 
as well as the drug’s positive mood effects (Kometer et al., 2013), while Haloperidol did not 
significantly influence the subjective effects of psilocybin (Vollenweider et al., 1998). 
 
Studies in humans and preclinical species indicate that psilocybin is safe and has low toxicity 
(Nichols, 2004; Passie et al., 2002). Psilocybin containing mushrooms have been used for 
thousands of years with artefacts and historical documents suggesting that ritual use of 
psilocybin-containing mushrooms occurred as early as 3000 years ago, with documented use 
in 16th Century Mexico, prior to Spanish prohibition on their use. Psilocybin has been given 

 
 
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to several hundred patients and volunteers in modern studies. In a thorough review of dosing 
sessions in 110 healthy subjects, dysphoric experiences/bad trips were rare and dose-
dependent and there was no evidence of subsequent drug abuse, flashback phenomena or 
prolonged psychoses (Erich Studerus et al., 2011). The majority of recreational magic 
mushroom users described their experiences as enriching, insightful and beneficial, but not 
something they would regularly repeat (Carhart-Harris & Nutt, 2010). The Imperial  College 
Psychedelics Research Group (PRG) team has substantial experience administrating psilocybin 
safely both to healthy psychedelic-naïve and psychedelic-experienced individuals and to 
patients with moderate to severe depression, in doses larger (oral doses up to 25mg) than 
proposed in the current study (oral dose of 5mg). 
 
Detailed information about psilocybin and its use can be found in section Experimental 
manipulation - Drug effects and the Psilocybin Investigators Brochure (IB) “Psilocybin 
Investigator’s Brochure January 2017”.   
 
1.2. 
Rationale for current study 
 
Self-harm is a major public health issue with health and societal impacts and the greatest risk 
factor for suicide (Morgan et al., 2017). Current treatments are long, costly and do not suit all 
young people (Glenn et al., 2019), highlighting the need to develop innovative and scalable 
interventions that are accessible to young people in the community that could offer a means 
of reducing the escalation of repetitive self-harm behaviour, which could prevent future 
suicide attempts. 
 
ImRS guides individuals to manipulate unhelpful mental images (such as the ones 
preceding self-harm) in a way that will change the associated emotions and the impact on 
behaviour (Holmes et al., 2007). However, emotional avoidance and fear of bringing negative 
images to mind can hinder full engagement in therapy. Due to psilocybin’s ability to enhance 
emotional acceptance, cognitive flexibility, and trait openness (Carhart-Harris et al., 2018), 
we propose that psychedelics could facilitate access to and re-scripting of dysfunctional 
mental imagery and consolidate change in the cognitive processes maintaining self-harm.  
 
Based on the above, we aim to test the cognitive processes by which a psychedelic-
augmented cognitive intervention may reduce self-harm behaviour, laying a mechanistic 
foundation for treatment development. 
 
We will examine the effect of a sub-hallucinogenic dose (5mg) of the psychedelic psilocybin 
compared to placebo, in combination with the cognitive-behavioural therapy technique 
Imagery Re-Scripting (ImRS) on cognitive processes that contribute to self-harm, in particular 
self-harm related mental imagery.   
 
Our overall hypothesis is that changes in imagery characteristics, cognitive processes (self-
report measures as well as performance on tasks) and self-reported symptomatology in the 
direction of more adaptive characteristics/performance will be greater following the 
psilocybin-augmented ImRS experimental manipulation compared to the ImRS + placebo. 

 
 
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We will use a placebo-controlled randomised design, where participants are allocated to 
either psilocybin-augmented ImRS or ImRS + placebo and primary outcomes are collected 
after 4 weeks. At 12-weeks, we will be collecting our secondary outcomes (see Flowchart 
below, figure 1). 
 
Findings from this study will inform cognitive and psychological mechanism for the 
development of a highly innovative combined pharmacological and cognitive intervention 
targeting self-harm in young people.  
 
 
2. 
OBJECTIVES 
 
2.1. 
Primary Objectives 
Our primary objectives are to measure if, compared to ImRS + placebo, ImRS + psilocybin: 
- Reduces the frequency, vividness, and compellingness of self-harm mental imagery, the 
intensity of associated negative emotions and the believability of associated negative 
cognitions, within the ImRS session and measured over 2-weeks and at 4-weeks after the 
experimental manipulation compared to baseline.  
- Enhances the frequency, vividness, and compellingness of novel adaptive mental imagery 
generated during ImRS, the intensity of associated adaptive emotions and the believability 
of associated adaptive cognitions, within the ImRS session and measured over 2-weeks and 
at 4-weeks after the experimental manipulation.  
- Modifies cognitive constructs that maintain self-harm, such as core cognitive schemas at 4-
weeks after the experimental manipulation compared to baseline. 
 
2.3. 
Secondary Objectives  
Our secondary objectives are to measure if, compared to ImRS + placebo, ImRS + psilocybin: 
- Reduces self-report measures of depression, anxiety, and stress.  
- Reduces self-harm cognitions (e.g., urge, craving, and motivation) and behaviour. 
- Modifies motivational biases related to self-harm measured via cognitive tasks. 
- Facilitates reward-based learning and cognitive flexibility measured via cognitive tasks and 
their computational models. 
- Increases self-compassion measured via a self-report questionnaire. 
- Generates altered state of consciousness and mystical experiences that are associated with 
self-harm imagery and novel adaptive imagery characteristics. 
 
Our secondary objectives will be measured at 4 weeks and 12 weeks post the experimental 
manipulation. Our overall hypothesis is that changes in imagery characteristics, cognitive 
processes (self-report measures as well as performance on tasks) and self-reported 
symptomatology in the direction of more adaptive characteristics/performance will be 
greater following the psilocybin-augmented ImRS experimental manipulation compared to 
the ImRS cognitive manipulation only.  

 
 
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Figure 1: Flowchart of study procedures and visits 

 
 
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In addition, further objectives are to measure if: 
- In participants randomised to psilocybin-augmented ImRS, the effects on mental imagery, 
cognitive schemas, depression, anxiety, stress, self-harm cognitions and behaviour and self-
compassion (as above) are maintained at 12-weeks after experimental manipulation.  
- To explore if changes in mechanistic outcomes correlate with any change in self-harm 
behaviour. 
 
 
3. STUDY DESIGN 
 
We will conduct a double-blind placebo-controlled study that will compare 5mg of psilocybin 
+ ImRS (psilocybin-augmented ImRS) to placebo (vitamin C) + ImRS on N = 20/group 
participants with an experience of self-harm behaviour and associated mental imagery.  
 
Participants will undergo three in-person visits at the NIHR Biomedical Research Centre 
Imperial College Clinical Research Facility (ICRF) (baseline, experimental manipulation, 1-
month outcome assessment), four remote visits (preparation, integration, 3-month follow-
up), and digital assessment using a smartphone app MindCraft for the duration of the study. 
Following the 1-month primary outcomes, a group integration will be implemented, either 
remotely or in-person, according to participant preference. 
 
3.1. 
ENDPOINTS  
All endpoints are calculated as between-group differences in change from baseline to 4-
weeks (primary outcomes) and 12-weeks (secondary outcomes) post-experimental 
manipulation, or as simple between-group differences for measures only collected post-
experimental manipulation (e.g., ratings of novel imagery characteristics).  
 
3.1.1. Primary endpoints 
- Frequency, vividness, compellingness, emotions intensity and cognitions believability scores 
on a 1-10 Likert scale related to self-harm and novel adaptive mental imagery 
- Scores on Young Schema Questionnaire Short Form (YSQ-SF; Young, 1994) 
-  
- Feasibility outcomes: participants' recruitment rate, retention rate for primary and 
secondary outcomes. 
 
3.1.2.  Secondary endpoints  
- Task performance (e.g., reaction time [RT], accuracy) to self-harm vs neutral pictures and 
positive vs neutral pictures on the Approach Avoidance task (AAT; (Loijen et al., 2020) 
- Task performance (e.g., RT, accuracy, learning rate) on the Probabilistic Reversal Learning 
(PRL; (Dombrovski et al., 2010) task and the Self-harm Dot Probe Task (SH-DPT; based on 
(Constantinou et al., 2010) 
- Scores on the Difficulties in Emotion Regulation Scale  (DERS ; (Hallion et al., 2018); and the 
Self-compassion scale (SCS; (Neff, 2003) 
- Scores on the SM-SH (state motivation for reducing self-harm scale) (Robinson et al., 2016) 

 
 
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- Scores on measures of psychedelic experience on based on scores on the mystical 
experience questionnaire (MEQ; (Barrett et al., 2015), challenging experience questionnaire 
(CEQ; (Barrett et al., 2016), and emotional breakthrough inventory (EBI; (Roseman et al., 
2019). 
 
 
4. PARTICIPANT ENTRY  
 
4.1. 
Population 
Young people aged 16-25 with at least 2 lifetime self-harm episodes, 1 in the past 4 weeks 
and who experienced self-harm-related mental imagery in the past 6 weeks.  
 
4.2. 
Inclusion criteria 
- At least 2 lifetime episodes of self-harm measured using the Self-Injurious Thoughts and 
Behaviours Interview (SITBI, Nock et al., 2007) and at least 1 self-harm episode in the past 
month  
- Self-harm-associated mental imagery in the past 6-weeks measured using the Self-harm 
Imagery Interview (SHII, Hales et al., 2011) 
- Any gender  
- Age: 16-25 years old 
- Good command of the English language 
- Mental capacity to provide written informed consent 
- Participant is willing to engage in tasks showing images of self-harm 
- Participant is willing to talk about mental health and self-harm behaviour 
- Normal ECG and blood pressure (determined by study medic) 
- Psychedelic naïve  
- No recreational drug use 7 days prior to the dosing visit 
- Comfortable using a computer and smartphone app for data collection, access to the 
internet from home and willing to have some of the study visits via video-link 
 
4.3. 
Exclusion criteria 
- Current or past history of psychosis or mania in themselves or a first-degree relative 
- Current severe suicidal ideation that constitutes a risk for their participation 
- Have a medically significant condition which renders them unsuitable for the psychedelic 
component of the study (e.g., hypertension, diabetes, severe cardiovascular disease, 
hepatic or renal failure etc.)  
- Previous psychedelic use 
- Current or chronic history of kidney or liver disease 
- Have previously experienced a serious adverse response after psychedelic use 
- Intoxication on any of the visits, as assessed by difficulty in walking, the slurring of speech, 
difficulty concentrating or drowsiness.  
- Clinically significant head injury (e.g., requiring medical or surgical intervention) that in the 
opinion of the investigators, contraindicates their participation 
- Severe learning disability (including dyslexia/dyspraxia) that needs support to perform daily 
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- Unwillingness or inability to follow the procedures outlined in the protocol 
- Are currently using a psychoactive medication (e.g.,) 
- History of psychosurgery 
- In the opinion of the study team, they are unlikely to comply with the study protocol and 
lifestyle restrictions that it imposes 
- Unstable physical illness 
- Heavy smoker  
- Those needing regular specified medication that might interact adversely with psilocybin 
e.g., selective serotonin reuptake inhibitor, 5HT1 agonists, mirtazapine, trazodone, 
analgesics that have serotonergic effects (tramadol), MAOI’s, antipsychotics with significant 
5-HT2A receptor antagonist actions (risperidone, olanzapine, and quetiapine) 
- Those unwilling to allow their GP or involved mental health practitioners to be informed of 
their participation  
- Women of childbearing age who are not using reliable contraceptive methods  
- Women of childbearing age who are unable to comply with or produce a positive pregnancy 
urine test 
 
4.4. 
Withdrawal criteria 
Participants may be withdrawn from the study if they are ill, become pregnant or if the 
investigator or study doctor feels that their participation in the study might be affecting 
their health. In the unlikely event that the participant’s capacity to consent changes during 
the study, they will also be withdrawn, and their healthcare team will be notified. 
 
 
5. STUDY PROCEDURES  
 
5.1. 
Recruitment 
The study will be advertised using posters and leaflets that will direct participants to the study 
website (www.imaginestudy.org), or to email imagine@imperial.ac.uk for more information. 
Posters will be put up in the local community and public spaces for example in: 
community centers, libraries, cafes, cinema toilets, shopping center toilets, schools, colleges, 
universities, GP surgeries, general hospital areas, A&E departments, Imperial student health, 
and mental health centers. The study will also be advertised using social media platforms 
(e.g., Instagram, Twitter, Facebook) that will direct potential participants to the study 
website. We will endeavour to recruit an equal number of males and females when possible. 
 
5.2. 
Study Screenings and Visits 
Online Screening 
Potential participants will visit the study website (www.imaginestudy.org), where they will be 
directed 
to 
the 
Qualtrics 
online 
screening 
form 
(https://imperial.eu.qualtrics.com/jfe/form/SV_dhcKgbBJtrSxjxQ). Participants will complete 
the online screening form, which includes questions on their demographics, mental health, 
history of self-harm, and smoking status. It also asks participants to complete the alcohol use 
disorders identification test (AUDIT) and the cannabis use disorders identification test revised 

 
 
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(CUDIT-R) as an initial screen for hazardous alcohol and cannabis use. This will take 
approximately 15-20 minutes to complete. 
 
Telephone/ video screening  
Potential participants will be initially contacted by the study team via text/email to confirm 
their interest in the study and arrange a short phone or video call to assess initial 
inclusion/exclusion criteria and answer any questions. Participants will be asked to confirm 
whether they have a history of self-harm within the past year and to confirm any methods of 
self-harm used (to prepare stimuli for the AAT). They will be asked to confirm whether they 
experience mental imagery (visualisation) related to self-harm and if they have experienced 
it within the past 6-weeks. Participants will also be asked about hobbies and other things they 
enjoy to prepare for the AAT and positive imagery task (PIT) in advance of the testing session. 
An overview of the study and testing session will also be given, and they will be sent a 
participant information sheet (PIS) to read and consider. This will take approximately 20 
minutes. Volunteers will be given at least 48 hours to consider the PIS and if they still wish to 
participate, the team will arrange a date and time for the screening session. 
 
V1: Screening and Baseline Assessment Visit  
 
Consent and screening 
The remaining screening will be completed in person at the ICRF, Imperial Centre for 
Translational and Experimental Medicine, Imperial College London. The screening will consist 
of an interview where the study will be discussed and explained, and the participants ’
understanding of the procedure, requirements and commitments are confirmed.  
 
Participants will be given ample time to take in all study information and to ask any questions 
and then written informed consent is taken. Consenting participants will be asked for their 
GP details and permission to inform their GP and any mental health practitioner actively 
involved in their care in the case the participant is identified as high-risk, and the clinician 
needs to contact the GP. A ‘Summary Care Record’ will also be requested from the GP. This 
will not be optional. This visit must be at least 2 weeks before the first experimental visit (V4).  
 
On location, a urine drug screen (UDS), an alcohol breathalyser test and a psychiatric and 
physical examination will be conducted by the study doctor. The volunteers will have an 
electrocardiogram (ECG) and their blood pressure (BP), heart rate (HR), height and weight will 
be measured. A pregnancy test will be performed for female participants if applicable. They 
will undergo a routine neurological exam and a standard psychiatric interview (Mini-
International Neuropsychiatric Interview v5 [MINI-5; (Sheehan et al., 2016)]). 
 
Any incidental finding from the above medical screening will be communicated by the study 
clinician to the participant and communicated to the GP with the participant’s consent.  
 
The study clinician will also assess the readiness, expectations, and motivation of the 
participants to take part in the study, blinding (psilocybin/placebo), stability of their 
environment (e.g., family setting) and taking a psychedelic substance. Usually, readiness for 

 
 
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a psychedelic intervention and generally for psychological intervention is assessed in studies 
using high doses of psychedelic substances. Despite the low dose (5mg) used in our study, we 
will incorporate this assessment.  
 
If the volunteer still appears to be suitable for the study, we will then introduce them to the 
study team, including those who will conduct the experimental sessions. Only subjects 
meeting all inclusion and none of the exclusion criteria will be included in the experimental 
phase. 
 
We will encourage participants to have a trusted person (friend or relative) accompany them 
to the testing facility and back home on the experimental session day (V3), and help them 
identify one if needed. If a participant feels they do not want this, or do not have a trusted 
person available to accompany them, a member of staff will offer to take them home after 
the session or put in place an adequate plan to ensure their safety (e.g. plan phone call to 
family member at home etc.).  
 
Baseline assessments during V1 
Participants will then complete self-report questionnaires on Qualtrics and computerised 
tasks.  
Questionnaires (round 1): 
       Visual Analogue Scales (VAS) measuring state affect 
Depression, Anxiety and Stress Scale (DASS-21; Antony et al., 1998) 
SITBI (self-injurious thoughts and behaviours interview) (Nock et al., 2007) 
SHII (Self-harm images interview) (Hales et al., 2011) 
NART (National Adult Reading Test) (Nelson & Willison, 1991) 
YSQ-SF (Young, 1994)  
SCS (Neff, 2003) 
CEQ-SH 
(Craving 
experience 
for 
self-harm) 
(Di 
Simplicio 
et 
al., 
2020) 
SM-SH (state motivation for reducing self-harm scale) (Robinson et al., 2016) 
Future Imagery Scale 
 
Computerised tasks (round 1): 
       Visual Analogue Scales (VAS) measuring state affect 
       PRL (Dombrovski et al., 2010) 
       Self-harm Dot Probe Task (SH-DPT; based on (Constantinou et al., 2010) 
 
Questionnaires (round 2): 
ACE (Adverse childhood experience) (Felitti et al., 1998) 
ASA (Anhedonia scale for adolescents) (Watson et al., 2021) 
TEPS (Temporal experience of pleasure) (Gard et al., 2006) 
DERS (Difficulty in emotional regulation scale) (Hallion et al., 2018) 
MSI-BPD (McLean Screening Instrument for Borderline Personality Disorder) (Zanarini et 
al., 2003) 
S-UPPS-P (impulsive behaviour scale) (Cyders et al., 2014) 
COHS (Creature of Habit Scale) (Ersche et al., 2017) 

 
 
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Computerised tasks (round 2): 
AAT (Loijen et al., 2020) 
Visual Analogue Scales (VAS) measuring state affect 
PIT (O'Donnell et al., 2018) 
 
App-based daily monitoring 
Participants will then be asked to download the MindCraft app (Kadirvelu et al., 2023) freely 
available on iOS and Android app stores. Once downloaded, they will be shown how to sign 
in using their unique participant code. MindCraft is a digital mental health app that enables 
capturing and tracking subjective experiences and behaviour in young people, as well as 
passive behavioural indices, and was co-designed with young people by the Faisal Lab at 
Imperial College London. MindCraft is currently used in research studies by our team in both 
general and clinical populations. Participants will be instructed to record daily occurrences of 
self-harm mental imagery, future positive mental imagery, affect, sleep and energy levels (5 
mins daily ratings) from 2-weeks prior to their experimental visit for the study duration. 
 
The researcher will also illustrate how to personalise active tracker data collection if any of 
the participants wants to track additional symptoms/experiences/behaviour that they feel 
are relevant to their wellbeing (e.g., self-esteem levels, socialisation). Researchers will ask 
participants to enable permission for the app to collect passive data, such as battery status or 
steps (these options can be turned off if the participant chooses). They will also show 
participants how to visualise the graphs tracking activity over time. Finally, they will suggest 
setting a daily reminder at the time of the day when a participant is most likely to respond 
and have 5 minutes available to complete the trackers.  
 
Debrief 
At the end of the baseline assessment, to minimise the possibility of any negative affect or 
distress, all participants will complete a positive imagery task (O’Donnell et al, 2018) and have 
a debrief session ensuring they are safe to go home (see below).  
 
V2: Preparation session 
Following the Screening Visit V1, participants will undergo a remote preparation session with 
one or both of the researchers/clinicians who will conduct the experimental session. This will 
provide a foundation for psychological preparation for the experimental session and allow 
additional opportunities for the relationship between the participant and the 
clinician/research team to develop. The preparatory session will be around 1 week before V3. 
The preparatory session will be conducted remotely (via phone/Skype/Zoom). Part of the 
preparation will be to warn the participants to expect some anxiety during the psilocybin 
administration, and they will be encouraged to let us know if they feel this. Participants will 
be advised to accept these feelings of anxiety and to allow the experience to unfold naturally, 
without psychological resistance. They will be informed of the setting and that a member of 
the team will always be present (see below). VAS scales will be completed at the start and 
end of the session. 
 

 
 
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V3: Experimental Session 
Participants will be collected from their home either by taxi or car (by a trusted person) and 
taken to the ICRF, in the early morning. They will be advised to have a light breakfast prior to 
being picked up. The exact timing will be determined by the distance they need to travel so 
that they can arrive by 09.00. The participant will be encouraged to be accompanied by a 
trusted person (e.g., partner, close friend, family member) but this will be left up to the 
participant.   
 
Screening 
On arrival, they will be asked if they agree to carry on participating in the study and their 
general health and compliance with study-specific restrictions will be assessed by a short 
interview. Once it is confirmed they are eligible to proceed, participants will undergo: a 
urinary drug screen, alcohol-breathalyser, and pregnancy test (if applicable) and vital signs 
(BP and HR). If still eligible, participants will then complete the following questionnaires and 
tasks. 
 
Baseline assessments during V3: 
STAI-S (Spielberger et al., 1983) 
DASS-21 (Antony et al., 1998) 
CEQ-SH (Craving experience for self-harm) (Di Simplicio et al., 2020)  
       ABUSI (Alexian Brothers Urge to Self-Injure) (Washburn et al., 2010) 
 
VAS measuring state affect 
 
Experimental manipulation  
Participants will be randomised to either psilocybin (5mg) or placebo (vitamin C) (1:1 ratio) 
using the online software application, Sealed Envelope™, on the day of V3 by a study clinician 
not involved in the experimental session, who will be unblinded and remain available in case 
of any adverse reaction/clinical need. The administration of psilocybin or placebo will be 
recorded in a drug accountability log, given by the research team, and recorded in the Case 
Record Form (CRF). The psilocybin capsules (GMP) and placebo capsules will be supplied by 
the USONA Institute and held by the team until required. 
 
Participants will be administered the drug (psilocybin or placebo) by a researcher, followed 
by a 3 hrs break. 
 
After the break, i.e., approximately 2 hr after the peak psilocybin effect (estimated at 1 hr 
after administration), participants will complete the cognitive manipulation (ImRS) together 
with a study clinician (see details below). If any of the participants require more time for the 
effects of psilocybin to wear off prior to ImRS, we will prolong the waiting time and request 
support from the Imperial Psychedelic Research Team.  
 
Outcome assessments during V3 
After ImRS participants will have a 1 hr break (approximately 5 hrs post-dosing/drug effects 
wear off), and then complete the post-manipulation outcome assessments, including: 

 
 
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(VAS) measuring state affect  
STAI-S (Spielberger et al., 1983) 
SCS (Neff, 2003)  
CEQ-SH (Craving experience for self-harm) (Di Simplicio et al., 2020) 
SM-SH (Robinson et al., 2016) 
MEQ (Barrett et al., 2015) 
CEQ (Barrett et al., 2016)  
EBI (Roseman et al., 2019) 
 
They will be instructed to continue recording daily affect, energy levels, and occurrences of 
mental imagery, including self-harm imagery, future positive imagery and their novel adaptive 
image using the MindCraft app. 
 
Debrief and physical health check 
Before leaving the session, participants will have a debrief with the researcher, who will check 
their affect, monitor risk, and make sure they have positive plans for the remainder of the 
day (see below for details). Participants will be able to leave after a final medical assessment 
to check they are physically fit to return home in a taxi with a trusted person or in a car driven 
by their trusted person. Participants will be able to go home within 5 h after dosing or later 
as soon as they are deemed safe to do so (see ‘drug effects’ section below). 
 
V4a and V4b: Integration sessions 
One day and one week after the experimental session participants will attend an integration 
session (two sessions in total). They will be asked about their experiences the previous day 
and of the week following dosing, how they slept, how they have felt etc. These sessions will 
be audio- and video-recorded (consent taken upon enrolment) for qualitative analysis. 
Content will follow standard procedures after psilocybin administration in psilocybin-assisted 
therapy, with an additional focus on mental imagery experiences. V4a and V4b will be 
conducted remotely (via phone/Skype/Zoom). VAS scales will be completed at the start and 
end of the sessions.  
 
V5: Primary Outcomes Assessment 
Participants will be invited to attend an outcomes assessment session 4-weeks after the 
experimental session in person at the ICRF. Participants will repeat the baseline assessment 
measures, plus an additional imagery assessment, see below. 
 
Outcome assessments during V5  
Questionnaires: 
YSQ 
(VAS) measuring state affect 
SHII (from last assessment only) 
SITBI (from last assessment only) 
CEQ-SH (from last assessment only) 
ABUSI (from last assessment only) 
MINI – Suicidality section 

 
 
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     ABUSI (Alexian Brothers Urge to Self-Injure) (Washburn et al., 2010)  
SCS 
SM-SH 
DASS-21  
DERS 
 
Computerised asks: 
AAT  
PRL  
SH-DPT 
 
Imagery task: 
The participant will be instructed to bring to mind the novel adaptive mental image that they 
had constructed during the experimental session ImRS procedure. Following 1 min of imaginal 
exposure, they will be asked to rate the image on vividness, the emotions, and thoughts 
intensity/believability that they had identified in the experimental manipulation session.  
 
Debrief  
At the end of the session, the same debrief procedure as in V1 will be used.  
 
V6: Group integration session 
Between V5 and V7, participants will complete a group integration session. Participants will 
be asked to discuss their drug, mental imagery, and mental health experience in a group 
setting, led by a trained member of staff. This session will be audio- and/or video-recorded 
(consent taken upon enrolment) for qualitative analysis. Content will follow standard 
procedures after psilocybin administration in psilocybin-assisted therapy, with an additional 
focus on mental imagery experiences. The visit will be held remotely over video call or in 
person, according to the participant’s preference. 
 
V7: Follow-up outcomes assessment 
The follow-up assessment will be completed over video call by participants initially allocated 
to psilocybin-augmented ImRS 12-weeks after the experimental session. It will include self-
report questionnaires on Qualtrics and a qualitative feedback interview to collect data on the 
subjective experience of the psilocybin-augmented ImRS procedures, acceptability, and 
potential barriers to translating the experimental manipulation into a clinical manipulation.  
 
Outcome assessments during V6 
 YSQ 
(VAS) measuring state affect 
SHII (from last assessment only) 
SITBI (from last assessment only) 
CEQ-SH (from last assessment only) 
ABUSI (from last assessment only) 
MINI – Suicidality section  

 
 
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     ABUSI (Alexian Brothers Urge to Self-Injure) (Washburn et al., 2010) 
SCS 
SM-SH 
DASS-21  
DERS 
 
V8: End of study 
Participants complete the study after the follow-up and outcomes assessment (V7). 
 
 
5.3. 
Experimental manipulation: psilocybin-augmented Imagery Re-Scripting 
(ImRS)  
ImRS is a therapeutic technique in cognitive behavioural therapy that modifies the content 
and features of maladaptive, often intrusive mental images associated with psychopathology 
or dysfunctional behaviours. A simplified ImRS procedure has been devised for the purpose 
of experimental studies (rather than clinical interventions), to standardise the ImRS steps, 
based on the Waterloo Images and Memories Interview (WIMI), and on clinical procedures 
(Moscovitch et al., 2011). We have used this procedure on approximately N=30 participants 
with a history of self-harm (same inclusion criteria as for this study) as part of the IMAGINE 
project. The procedure lasts approximately 45-60 min. Most participants found the procedure 
feasible, informative and some even helpful. Two out of 30 participants terminated the 
procedure early as they found the exposure phase too distressing or found it hard to identify 
alternative adaptive imagery; however, the distress (one participant) didn’t persist and was 
quickly reverted after completing study measures and the debrief procedures. 
  
Introduction 
First, the therapist illustrates the ImRS procedure. Then participants begin with a mental 
imagery practice exercise, the ‘lemon ’exercise, to familiarise themselves with using mental 
imagery. They are instructed to imagine a lemon; how it looks or feels. After the participant 
is confident they understand what imagery is and the ImRS procedure they will follow, the re-
scripting section begins.  
 
Self-harm mental imagery exposure 
The participant is instructed to choose the most significant self-harm-related mental image 
that they feel comfortable bringing to mind. They are asked to identify and rate 
retrospectively what emotions and at what intensity (scale 1-100%) are usually associated 
with this image. They are then asked to bring to mind the image and maintain it in mind 
making it “as real as usually feels” for 1 min. Following this mental exposure, they are asked 
to re-rate the emotions previously listed. They are also asked about associated thoughts and 
beliefs and asked to rate their “believability” (scale 1-100%) during the imaginal exposure.  
 
 
 
 
 

 
 
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Identifying ‘antidote’ emotions and thoughts 
The therapist then guides the participant to identify what alternative emotions and 
thoughts/beliefs would be more helpful to experience at times of self-harm urges (an 
alternative to the ones associated with the self-harm image), termed ‘antidote’ emotions and 
thoughts. Together they brainstorm an alternative image that could encapsulate these and 
hold a different meaning that would ultimately make the individual less likely to self-harm in 
real life.  
 
Imagery Re-Scripting  
The therapist then guides the participant to bring to mind the self-harm imagery again (1min) 
then turn it into or switch it for the alternative, ‘antidote ’image, holding it in mind for 1 min. 
This is repeated twice. After each re-scripting the participant is asked to rate the emotions 
intensity and thoughts/beliefs believability of the self-harm and novel adaptive image (scale; 
1-100%).  
 
Adaptive mental image exposure. 
Finally, participants are asked to bring to mind and hold in mind only the novel adaptive 
‘antidote’ image for 1 min and emotions and thoughts ratings are repeated for the final time. 
 
Drug effects 
The effects of orally administered psilocybin at low-moderate (5mg) doses last for 
approximately 2-4 hours peaking at 1 hour post-administration. The 5mg dose that we have 
chosen is low, so we are not expecting any profound or extensive psychedelic experience. 
However, there is a possibility of differing experiences to be had by the individual participants 
and so all necessary precautions will be taken.  
A trained study team member (researcher, therapist, medic) will be sitting next to the 
participants for the duration of the drug effect, i.e., 3 hr before ImRS, and approx. 1 hrs after 
ImRS and will check in hourly with the participant aside from the ImRS, but otherwise, only 
engage in contact if the participants choose to initiate contact with them. After drug 
administration, participants will be encouraged to wear an eye mask for the majority of these 
4 hrs and encouraged to “go into” the experience, this will include the period during the ImRS. 
This procedure has been used in previous clinical studies with psilocybin conducted by the 
Imperial College team. 
 
Current recommendations in the field include that the psychedelic drug only be taken in a 
positive environment where the participant feels comfortable and relaxed and is supported 
(Johnson et al., 2008). To that end, efforts will be made to arrange the intervention room to 
promote relaxation without compromising medical safety. Mobile phones will be switched 
off during every session and efforts will be made to minimize unexpected interruptions.  
Relaxing music will be used to facilitate calm and relaxation outside the period of ImRS. 
 
The schedule will afford a minimum of 4 hours of observation after the oral ingestion of 
psilocybin, which is sufficient time for most psychedelic or physical effects to have 
disappeared, as most of these effects last no longer than 4 to 6 hours after oral psilocybin is 
administered (Gouzoulis-Mayfrank et al., 1999; Hasler et al., 2004; Hollister, 1961; Passie et 

 
 
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al., 2002; Vollenweider et al., 1998; Wittmann et al., 2007). If participants are not fit to leave 
after 4 hours, they will continue to be monitored until they are.  It is expected that the 
participants will be able to return home that day considering the low dose of psilocybin they 
will receive. In other similar studies, the Imperial PRG have given psilocybin in over 54 dosing 
sessions to healthy volunteers and other patient groups at differing doses of at least 10mg 
and all have been safe to leave on the evening of their test day. In two recent psilocybin trials 
in patients with moderate to severe depression 20 of them had an initial test dose of 10mg, 
double the dose we are using in our study, after which very few experienced any effects, and 
these were very mild and resolved within the testing period and were able to go home that 
day (Carhart-Harris et al., 2016). When they are assessed to be safe to return home, they will 
be sent home by taxi or in a car.  Participants will be accompanied by a trusted person – or if 
this is not possible by a member of the core study team. This will mitigate problems if any 
effects of the pharmacological challenge manifest following leaving the ICRF, which is not 
expected. Participants will be given a card containing the emergency contact details of the 
study team and information about the study in case they experience any untoward events or 
issues overnight, or throughout the rest of the study.   
 
5.4. 
Mood repair and debrief procedures 
At the end of the in-person sessions V1, V3 and V5, a study team member will ensure that 
participants are feeling okay before leaving.  
 
To minimise the possibility of increased negative affect after sessions including discussing 
mental health issues and showing self-harm-related images, all participants will complete a 
Positive Imagery Task (PIT) previously shown to improve positive affect (O’Donnell et al, 
2018). The task will be completed at the end of the baseline session V1 and outcome 
assessment session V5, as well as at the end of the experimental session V3 if needed to 
improve positive affect before participants go home.  
 
In the task, participants are trained in positive imagery generation by combining a picture and 
a word cue and instructed to rate the vividness and valence of this imagery (e.g., a neutral 
image of the countryside with the words ‘fun walk’). Picture-word cues will relate to activities 
the participants enjoy (described during the telephone screening). We have successfully used 
this task in our IMAGINE project (IRAS: 19/SC/0275) where we have tested the same 
population using the same tasks and ImRS procedure. 
 
Participants will also be given the opportunity to watch a film with calming positive images, 
from a publicly available series, shown to be soothing (www.projectsoothe.com). They will 
then be given a drink and asked questions related to current feelings, what they are doing 
that evening etc., to ensure they have a positive plan. They will also be given the opportunity 
to ask questions about the study. 
 
For online sessions V2 and V6, participants will be debriefed at the end of the session to 
ensure they are feeling okay before ending the call and if needed the same debrief procedures 
will be adopted (PIT and projectsoothe video). 
 

 
 
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6. MATERIALS 
 
6.1. 
Experimental tasks 
Approach Avoidance Task (AAT; (Loijen et al., 2020) (10 minutes) 
Approach and/or avoidance biases will be assessed by the AAT. During this task, participants 
will see either self-harm images, positive images, or neutral images, and will respond to these 
by moving the joystick toward themselves (approach) or away from themselves (avoidance). 
Movement of the joystick is accompanied by zoom-in (approach) or zoom-out (avoidance), 
strengthening the subjective impression of pulling the picture in or pushing it out. Reaction 
times will be measured to determine if they show avoidance (longer reaction time) or 
approach (shorter reaction time) towards the self-harm, positive or neutral stimuli. Self-harm 
images for the AAT have been reviewed by our YPRG and the task has been used in our 
IMAGINE study with the same population.   
 
Probabilistic Learning Task (PRL; (Dombrovski et al., 2010) (15 minutes) 
During this task, learning from rewards and punishments will be assessed. In this task, 
participants are required to win as many points as they can. In the first phase of the task, 
participants learn that responding to certain abstract stimuli results in winning or losing 
points. In the second phase, associations reverse, and participants are required to adapt their 
performance. The reward consists in winning 100 points and a ‘yay’ sound, while the 
punishment consists in losing 100 points and a ‘boo’ sound. 
 
Self-harm Dot Probe Task (SH-DPT; based on (Constantinou et al., 2010) (15 minutes) 
During this task attention bias to self-harm cues is assessed. Participants are presented with 
both self-harm and neutral images (cues), which are matched to the self-harm images for 
complexity, colour, and type. Each participant will be allocated their own task based on their 
methods of self-harm, where half of the self-harm images will be tailored to their methods. 
The other half of the images will be the same across all participants to reduce task design 
variability. In the task, a fixation cross is shown, followed by two images. One of the images 
will then be replaced by either one or two dots (probe). Participants are instructed to 
determine as quickly as possible whether one or two dots were showing. A self-harm trial was 
‘congruent’ if the probe replaced the self-harm image or ‘incongruent’ if the probe replaced 
the neutral image. Congruent, incongruent, and neutral trials were used to calculate an 
Attention Bias Index and Disengagement Index for each participant.  
 
Positive Imagery Task (PIT) (O’Donnell et al, 2018) (15 minutes) 
See section ‘5.4. Mood repair and debrief procedures’ for task details.  
 
6.2. 
Questionnaires 
Self-Injurious Thoughts and Behaviours Interview (SITBI) (Nock et al, 2007).  
Only the non-suicidal self-injury section of this interview will be used, modifying the term 
‘non-suicidal self-injury’ to ‘self-harm’ as our definition includes all self-harm behaviour 
regardless of intent. This interview assesses various aspects of self-harm behaviour including 
frequency, methods, and functions. This interview has excellent inter-rater reliability and 

 
 
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test-retest reliability. One question on recency of self-harm will also be included, for example, 
‘When was the last time you self-harmed?’ 
 
Alexian Brothers Urge to Self-Injure Scale (ABUSI) (Washburn et al, 2010).  
The ABUSI measures the intensity of the urge to self-harm over the past week. This measure 
captures both emotional and cognitive aspects of how motivated someone is to engage in 
self-harm. It has shown adequate internal consistency, test–retest reliability, sensitivity to 
change, and convergent, predictive, and incremental validity. 
 
Craving Experience Questionnaire for Self-Harm (CEQ-SH) (Di Simplicio et al., 2020, adapted 
from May et al, 2014). This measure assesses the frequency and strength of the desire to self-
harm over the past week. It contains 11 items giving subscales of Intensity, Imagery, and 
Intrusiveness.  
 
Self-Harm Images Interview (SHII) (Hales et al., 2011).  
The SHII documents the self-harm-related mental images most significant to the individual. 
The image does not have to be depicting the act of self-harm, but it has to be related to self-
harm. Participants are asked to rate the extent to which each emotion was experienced 
immediately after experiencing the images, on a five-point rating scale ranging from 1 (‘very 
slightly or not at all’) to 5 (‘extremely ’). Participants are also asked to rate on a scale ranging 
from 0 to 9 several other qualities related to the image, e.g., how vivid or compelling it is.  
 
State Motivation for Reducing Self-harm Scale (SM-SH) (Robinson et al., 2016)  
This is a 12-item scale assessing motivation to control self-harm behaviour. Participant are 
asked to rate from 0 (never) to 10 (constantly), the strength of motivational cognitions “right 
now...” followed by, for example, “...how strongly do you want to do it?”.  
 
Mystical Experience Questionnaire (MEQ30) (Barrett et al., 2015)  
This is a 30-item revised Mystical Experience Questionnaire, developed to measure mystical-
type experiences occasioned by psilocybin-containing mushrooms. It is comprised of four 
factors: mystical (including items from the internal unity, external unity, noetic quality, and 
sacredness scales of the original MEQ), positive mood, transcendence of time and space, and 
ineffability.  
 
Challenging Experience Questionnaire (CEQ) (Barrett et al., 2016)  
This is a validated questionnaire that explores potentially challenging experiences of affective, 
cognitive, and somatic nature while under the influence of psilocybin. It has 26 questions, 
five-point Likert scale, and is divided into seven dimensions: (a) Isolation, (b) Grief, (c) Physical 
distress, (d) Fear, (e) Insanity, (f) Paranoia, and (g) Death, to provide a phenomenological 
profile of challenging aspects of experiences with psilocybin. Factor scores were associated 
with difficulty, meaningfulness, spiritual significance, and change in well-being attributed to 
the challenging experiences. 
 
 
 

 
 
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Emotional Breakthrough Inventory (EBI) (Roseman et al., 2019)  
This is a validated questionnaire exploring the phenomenon of experiencing emotional 
release or breakthroughs under the influence of psychedelic substances. It has 8-items, out 
of which two were ‘negative’ items that required reverse scoring. Items were rated using a 
visual analogue scale (VAS) (0–100, with incremental units of one) with zero defined as ‘No, 
not more than usually’, and 100 defined as ‘Yes, entirely or completely’. Items include “I faced 
emotionally difficult feelings that I usually push aside; I felt able to explore challenging 
emotions and memories” and “I felt emotionally stuck throughout, without breakthrough”.  
 
Depression, Anxiety, Stress Scale (DASS-21) (Antony et al., 1998)  
This questionnaire measures depression, anxiety and stress and 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. Participants are asked to rate on a 4-point Likert scale how much 
21 items related to them over the past week (e.g., ‘I found it hard to wind down’).  
 
State-Trait Anxiety Inventory – State (STAI-S) (Spielberger et al., 1983)  
This questionnaire measures state anxiety. It has 20 items including, “I am tense; I am 
worried” and “I feel calm; I feel secure.” All items are rated on a 4-point scale (e.g., from 
“Almost Never” to “Almost Always”). Higher scores indicate greater anxiety. 
 
Difficulties in Emotion Regulation Scale Short Form (DERS-SF) (Hallion et al., 2018) 
(Kaufman et al, 2016) This scale measures general emotion regulation ability as well as six 
subscales that measure various aspects of emotion regulation, for example, difficulties 
engaging in goal-directed behaviour when upset, and limited access to emotion regulation 
strategies. The scale has 18 items and has been adapted from the original long version. 
Participants are asked to rate these items on a 5-point Likert scale. The scale has high internal 
consistency. 
 
Anhedonia scale for adolescents (ASA) (Watson et al., 2021)  
This is a validated 14-item scale designed specifically for adolescents to measure loss of 
interest and pleasure in previously enjoyable experiences. It has one general factor and three 
specific factors producing the best fit to the data, (1) Enjoyment, Excitement, and Emotional 
Flattening (negatively framed); (2) Enthusiasm, Connection, and Purpose (positively framed); 
and (3) Effort, Motivation, and Drive (negatively framed).  
 
Short Impulsive Behaviour Scale (S-UPPS-P) (Cyders et al., 2014)  
This 20-item scale measures five subscales of impulsivity (positive urgency, negative urgency, 
lack of premeditation, perseverance, and sensation seeking). Participants are required to rate 
how much they agree or disagree with these items on a 4-point Likert scale. This scale has 
good internal consistency and has replicated the internal consistency of the original long 
UPPS-P. 
 

 
 
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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. 
 
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.  
 
Smoking assessment 
Participants will be asked questions about their smoking and vaping, such as: 
Do you smoke? Yes/No/Occasionally 
If yes, how many cigarettes do you smoke a day? 
Do you vape? Yes/No/Occasionally 
If yes, how many times do you vape a day? 
 
MINI The Mini International Neuropsychiatric Interview (MINI) (Sheehan et al., 2016) 
It is a short structured diagnostic interview which explores 17 disorders according to DSM 
diagnostic criteria. This interview will be carried out by trained researchers. Depending on the 
number of disorders experienced by participants the time taken for interview varies. In the 
current sample, it is estimated that the interview will take approximately 30-45 minutes. 
 
McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD) (Zanarini et al., 
2003)  
It is a validated 10-item screening measure for Borderline Personality Disorder (BPD) with all 
items based on the DSM-1V diagnostic criteria for BPD. Two items are based on 
the ninth DSM-IV criterion of paranoia/dissociation, and each of the remaining eight items is 
based on the remaining eight DSM-IV criteria. 
 
National Adult Reading Test (NART) (Nelson & Wilson, 1991)  
It is a widely used measure of IQ in clinical research. Participants are given a list of 50 
predefined words and asked to read these aloud. The number of words correctly and 
incorrectly pronounced are then scored.  
 
Adverse childhood experience (ACE) (Felitti et al., 1998)  
It is a 10-item, widely used questionnaire to define physiological and psychological abuse 
during childhood and to define violence against the respondent’s mother.  
 
Temporal experience of pleasure (TEPS) (Gard et al., 2006)  
It was designed to measure individual trait dispositions in both anticipatory and 
consummatory experiences of pleasure. It contains 18-items, with a 10-item anticipatory 
pleasure scale and an 8-item consummatory pleasure scale. 
 

 
 
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Young schema questionnaire short form (YSQ) (Young et al., 1994)  
This is a 75-item questionnaire, developed to assess Early Maladaptive Schemas, which 
account for the dysfunctional beliefs in individuals with personality disorders or maladaptive 
personality traits.  
 
Self-compassion scale (SCS) (Neff, 2003)  
This is a validated and reliable 13-item scale. It measures self-compassion; the notion of being 
kind and understanding to oneself in instances or pain or failure, rather than being harshly 
self-critical. 
 
Creature of Habit Scale (COHS) (Ersche et al., 2017) 
This scale assesses the tendency towards routine behaviour in everyday life and automaticity 
in eating behaviour, both of which provide a valid and reliable index of habit proneness. 
Participants rate on a 5-point Likert scale how much they agree or disagree with 27 items. 
Participants with restrictive eating disorders will be excluded from part two of the scale 
(automaticity in eating behaviour) during analysis.  
 
7. ADVERSE EVENTS 
 
7.1. 
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 should 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, should also be considered serious. 
 
7.2. 
Reporting procedures  
All adverse events should be reported.  Depending on the nature of the event the reporting 
procedures below should be followed.  Any questions concerning adverse event reporting 
should be directed to the Chief Investigator in the first instance.   
 
7.2.1. Non-serious AEs 
All such events, whether expected or not, should be recorded - it should be specified if only 
some non-serious AEs will be recorded, and any reporting should be consistent with the 

 
 
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purpose of the trial endpoints. Self-harm behaviour (mild to moderate) being the pre-existing 
condition will not be recorded as a non-serious AE. 
 
7.2.2. Serious AEs 
An SAE form should be completed and emailed to the Chief Investigator (Martina Di Simplicio) 
within 24 hours. However, relapse in self-harm behaviour (severe) including hospitalisation, 
and hospitalisations for elective treatment of a pre-existing condition do not need reporting 
as SAEs. 
 
All SAEs should be reported to the <name of REC> where in the opinion of the Chief 
Investigator, the event was: 
• 
‘related’, i.e., resulted from the administration of any of the research 
procedures; and 
• 
‘unexpected’, i.e., an event that is not listed in the protocol as an expected 
occurrence 
 
Reports of related and unexpected SAEs should 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 must also notify the Sponsor of all related and unexpected SAEs. 
 
Local investigators should 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 (m.di-simplicio@imperial.ac.uk) 
 
Please send SAE forms to: xxx 
Tel: xxx (Mon to Fri 09.00 – 17.00) 
 
 
8. STATISTICS AND DATA ANALYSIS 
 
8.1. 
Sample size 
As this is an experimental medicine study, we have not conducted a formal sample size power 
calculation. Recommended sample sizes for feasibility studies range from 20-40 per group 
(Teresi et al., 2022). Previous first-in-kind studies exploring the effects of psilocybin had 
samples ranging between 10-20 participants, typically using a within-subject design with 
placebo or low-dose psilocybin vs. full-dose psilocybin approximately 1-4 weeks apart 
(Carhart-Harris et al., 2018; Carhart-Harris et al., 2016; Griffiths et al., 2016; Grob et al., 2011). 
We have chosen a between-subject design as it is unknown if the ImRS manipulation may 
exert effects on our primary outcomes that may last beyond the above within-subjects 
interval of 1-4 weeks, which could confound effects in a within-subjects design.  
 
 

 
 
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8.2. 
Statistical analysis 
As our study is likely unpowered to run inferential statistics on primary and secondary 
outcomes, we will primarily run descriptive statistics and measures of effect size in the 
between-group and within-group differences (post vs pre-experimental manipulation) on our 
self-report and cognitive measures. We will also explore whether any differences in task 
performance (e.g., reaction times) are influenced by self-harm, imagery, and psychedelic 
experience measures. Behavioural data from the learning task will also be explored using 
computational methods, for example, a reinforcement learning model with free parameters 
such as i) memory, ii) learning rate from rewards, iii) learning rate from punishments and iv) 
exploration (Dombrovski et al., 2010). Data will be analysed using software packages such as 
SPSS, R, Python and Matlab.  
 
8.3. 
Data storing 
Data and all appropriate documentation will be stored for a minimum of 10 years (5 years if 
ICHT sponsored study) after the completion of the study, including the follow-up period.   
 
 
9. REGULATORY ISSUES  
 
9.1. 
Ethics Approval  
The study has obtained approval from the NHS xxx Research Ethics Committee (REC) 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.  
 
9.2. 
Managing risks related to psychedelic treatment 
Before, during and after the dosing session, participants will receive psychological support 
from trained clinicians. On the dosing day, participants will only be allowed to leave the ICRF 
once the study psychiatrist is confident that they are fit to do so and signs the participant out. 
We will strongly encourage participants to bring a support person (friend or family member) 
with them.  
The participant will be asked to return home in the company of a support person/next-of-kin 
and if this is not possible, then to have their support person waiting for them at home. 
Participants will be asked to text or call us when they return home. We will also have the 
contact details of their support person/next-of-kin so that we can contact them if we cannot 
manage to contact the participant themselves.  
 
Both the participant and their support person will be encouraged to contact us should any 
problems arise. In this way, any concerns in the immediate period or thereafter can be easily 
brought to our attention. A 24-hour contact card outlining contact with the study team and 
emergency services will be provided.  
 

 
 
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9.3. 
Pharmacological challenge – psilocybin 
Psilocybin is a safe drug and has been given to several hundred patients and volunteers in 
modern studies.  In a thorough review of dosing sessions in 110 healthy subjects, dysphoric 
experiences/bad trips were rare and dose-dependent and there was no evidence of 
subsequent drug abuse, flashback phenomena or prolonged psychoses (Erich Studerus et al., 
2011). In addition, the dose we plan to use in this study is low and any effects are expected 
to be less as a result of this.  However, here are some of the key ethical and safety 
considerations. 
 
Recent independent assessments of the harms of popular drugs of abuse, conducted by 
international experts (Nutt et al., 2007; Nutt et al., 2010; van Amsterdam & van den Brink, 
2010) and experienced drug users (Carhart-Harris et al., 2011; Morgan et al., 2010) have 
consistently rated magic mushroom (psilocybin) as one of the least harmful recreational 
drugs.  Commonly cited risks include: prolonged psychotic reactions, flashback 
phenomena/hallucinogen persisting perceptual disorder (HPPD), and bad trips.  Prolonged 
psychotic responses are extremely rare in clinical studies with psilocybin (< 1 %) (Erich 
Studerus et al., 2011), even with very high doses (Griffiths et al.,2011) and none have been 
reported in modern studies or studies with patients (Carhart-Harris et al., 2011; Grob et al., 
1996; Moreno et al., 2006). The risk of flashback phenomena is also minimal. Typically, 
flashbacks or HPPD refers to drug-like visual perceptual effects (e.g., “trails” or geometric 
patterns) occurring when no drug has been taken.  The two largest surveys on this 
phenomenon found that very few psychedelic drug users (3 – 4 %) report perceptual changes 
that are distressing to them (Carhart-Harris & Nutt, 2010). There have been no cases of 
flashback-like symptoms occurring in modern clinical studies with psilocybin (Erich Studerus 
et al., 2011)  – even with very high doses (Griffiths et al., 2016).  
 
Negative acute psychological experiences or ‘bad trips’ do occur more frequently, but they 
are strongly dose-dependent (Griffiths et al., 2011; E. Studerus et al., 2011).  In a sample of 
36 healthy subjects given a high oral dose of psilocybin (30 mg), 11 subjects reported strong 
anxiety at some point during their session (Griffiths et al.,2011).  However, the anxiety was 
short-lived in every case and no persistent negative mood effects were reported.  Most of the 
subjects reported that their experience had been insightful and beneficial, and this positive 
appraisal of their experience was sustained (Griffiths et al., 2008). This is consistent with the 
claim that psychologically ‘challenging’ psychedelic drug experiences can be especially 
beneficial – if properly mediated.  In work that the Imperial Centre for Psychedelic Research 
has conducted, when dosing 40+ subjects with 2 mg psilocybin i.v., 30 of which took place in 
a spatially restrictive and noisy MRI scanner, anxiety scores were not significantly higher after 
psilocybin than placebo.  No subjects showed panic or asked for their scans to be aborted.   
 
Patients with psychiatric vulnerabilities are thought to be more likely to experience bad trips, 
but we will strive to minimize this risk through psychological preparation, good patient-staff 
rapport, and a positive environment.  Bad trips are best managed psychologically (Griffiths et 
al., 2008, Johnson et al., 2008) and administration of a benzodiazepine would only be used in 
cases of severe panic.  Detailed protocols are available for the safe management of clinical 
research with psychedelics (Johnson et al., 2008). The summary of side effects associated with 

 
 
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oral psilocybin can be found below and in the investigator’s brochure, which will  serve as the 
reference safety information for this study: 
 
Below is a summary of the prevalence of side effects: 
Common:  
Visual hallucinations, feelings of unreality and altered sense of time. 
Increased anxiety, particularly at the onset of the drug effects.   
Increased heart rate and blood pressure (We will check heart function at screening and 
patients with heart abnormalities will be excluded from the study). 
Transient headaches, lasting for 1 to 2 days (max) post-dosing 
 
Less common:  
Nausea   
Dizziness, drowsiness, fatigue, and sleepiness. 
A ‘bad trip ’/ ‘challenging experience ,’i.e., negative thoughts and mood during the short-
term drug effects (in other psilocybin studies, good preparation, support during the 
experience and integration can mitigate negative impacts of this. With support, challenging 
content can be worked through and contribute to a psychological ‘breakthrough ’on the part 
of the patient. Recent evidence indicates that challenging psychological experiences in 
supportive environments can produce therapeutic benefits, improving psychological well-
being in the long term (Griffiths et al.,2016). The risk of this is also lower with 5mg, a low dose.  
Temporary paranoia or suspiciousness  
 
Rare:  
Flashbacks or persisting perceptual phenomena (we did not observe any cases of this in our 
work with psilocybin.  However, about 10 % have reported perceptual effects lasting beyond 
the acute drug effects in experiments with orally administered psilocybin (although they were 
not reported as distressing and are typically transient), about 35 % of recreational users of 
psychedelics describe this and less than <5 % describe them as distressing.   
Worsening of mental state after the drug experience is rare and was not seen in our work or 
that of others.  However rare cases are reported in the literature.   
 
It is strongly advised that psychedelic drugs only be taken in a positive environment where 
the patient feels comfortable and relaxed and is supported (Johnson et al., 2008). For this 
reason, we will arrange the intervention room to promote relaxation without compromising 
medical safety.  In addition, the following precautions will used to minimise any negative 
events. 
 
Prior to drug administration, we will prepare each participant to ensure that they are aware 
of what to expect (1 preparation session).  We will also ensure that they meet the key 
members of the research team prior to dosing.  Professor Griffith’s (Johnson et al., 2008) team 
have used this approach and believes it to significantly reduce the possibility of any 
psychological adverse events following administration and serve to put participants at ease 
in the process. We have also used this approach in previous studies using psilocybin for 
depression at Imperial College and found the same.   

 
 
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Participants will be escorted and chaperoned by a member of the research team at all times 
throughout their participation in the study and for the 3 to 4 hours during which they will be 
under the acute effects of psilocybin they will always be supported by at least one team 
member. 
 
The acute effects of the drug should be over within 4 hours following administration.  We will 
carefully monitor the participant for the duration of their stay at the ICRF. Staff will be vigilant 
of any overly unusual behaviour, anxiety, and paranoia. Interpersonal exchanges that would 
be readily overlooked in a normal state of awareness may assume extreme and confusing 
meanings for persons under the influence of a psychedelic substance.  Staff will be aware of 
this and adopt an open and non-judgmental manner, allowing the participant to speak freely 
without challenge. 
 
On occasion, nursing staff or other staff may be called upon to monitor a participant, but this 
will be rare as there will normally be sufficient personnel from the research team to perform 
this function. 
 
We do not envisage any serious side-effects from the administration of the drug but, 
participants may experience anxiety reactions or paranoid thoughts.  These are likely to be 
short-lived and will be managed by psychological approaches such as reassurance and 
adopting a calm and supportive demeanour and by using behavioural techniques such as 
guided imagery. There were no serious adverse events in our two previous studies using 10mg 
and 25mg psilocybin in patients with moderate-severe depression. 
 
If the situation were to deteriorate further, the research team may have to be more proactive 
in their attempts to calm the patient and reduce distress and this may require an assertive 
tone of voice and/or the supportive hand-holding of the individual if their behaviour becomes 
erratic, for example.  This would only be done in an attempt to alleviate the participant’s 
distress and maintain their and the research team’s safety. This will be discussed with the 
participants beforehand in the preparation sessions. 
 
In the unlikely event that a participant becomes behaviourally disturbed, medical personnel 
will be on hand to physically restrain or administer tranquillising medication if necessary. 
Typical doses administered would initially be PO 5 – 10 mg diazepam, or an equivalent dose 
of another benzodiazepine, which can be repeated and titrated according to the product 
license to achieve the required effect. If such an adverse event were to occur, the study 
psychiatrist will closely monitor the participant at all times and in no circumstances will they 
be permitted to leave the ICRF until the psychiatrist is satisfied that they are well enough to 
do so.   
 
A final contingency for the handling of any persisting events that mean the clinical team are 
unable to allow them to go home on the test day will be to take them to the nearest A&E 
department (Charing Cross Hospital) for further assessment and treatment. 
 

 
 
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On discharge from the ICRF, the participant will be reviewed which will encompass an 
assessment of their current level of risk and whether they have returned to their normal level 
of functioning.  Once this is performed, the psychiatrist, together with the rest of the team, 
will decide if it is safe for them to leave the unit and return home. 
 
On discharge from testing, phone numbers for key members of the research team will be 
provided to the participants, along with a leaflet with further information on organisations 
that can offer support in times of need. 
 
A follow-up after the dosing day and a 1-month follow-up are in place for monitoring the 
participant’s status and mental health condition.  We will therefore be able to detect and 
assess any delayed or persisting adverse events. Participants and their trusted person will be 
encouraged to contact us should there be a persistent deterioration in their mental or 
physical health.   
 
Should we have any concerns about the participant’s mental health and safety during the 
study or follow-up the same procedures will be followed as described below. 
 
9.4. 
Managing risk from exposure to self-harm stimuli, mental imagery of self-
harm and assessments of self-harm / suicide and mental health 
The tasks and stimuli used in the study are based on tasks and stimuli already used in our 
previous experimental studies (IRAS: 19/SC/0275) with individuals who self-harm and no 
incidents were reported attributable to these (Rodrigues et al., 2023). However, theoretically, 
it is possible that a number of procedures (listed below) included in the study may result in (i) 
causing serious distress or (ii) may reveal information relevant to the participant’s mental 
health and safety such as risk of self-harm and suicide. If this is the case the necessary steps 
to manage participants’ wellbeing and safety will be taken as described below. The Chief 
Investigator (CI) is a Consultant Psychiatrist with previous experience in conducting clinical 
and experimental research with vulnerable young people including young people with self-
harm and pharmacological experimental medicine research. The CI and other research 
clinicians on the team will overview all experimental procedures and be available either on-
site or over the phone during the experimental sessions.  
 
Study procedures, which may result in (i) increased perceived distress and/or (ii) disclosure 
of information relevant to the participant's mental health and safety are as follows: 
 
1) Responding to the MINI questions. 
2) Completing questionnaires on mood, self-harm imagery, and self-harm assessment.  
3) Recalling mental images related to past negative outcomes associated with self-harm, 
during ImRS, which may impact on the participants’ mood.  
 
While the risk of major distress occurring is minimal based on previous research using similar 
procedures, researchers will always remain sensitive to signs of participant distress and will 
terminate any procedure if the participant becomes distressed and wishes to stop.  
Researchers will also check the participant’s mood state and safety upon completion of the 

 
 
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self-report questionnaires and computer tasks. Participants’ well-being and safety will be 
considered as a priority concern at all points in the study, and a clinician will be always 
available on-site when testing participants to support them if needed. To minimise anxiety to 
the participants during the study, where possible, the sessions will be conducted by the same 
study personnel. 
 
The risk of distress occurring will also be minimised in the following ways: 
 
Responding to the MINI assessment and questionnaires:  
Participants will be fully informed about the content of the MINI and other questionnaires. 
The MINI will ask questions about current and prior psychiatric disorders. Questions will also 
be asked about drug and alcohol use, including illegal drugs. All these questions are a standard 
component of psychiatric interviews. The participant information sheet will provide 
information about the type of questions participants should expect in the interview, so they 
can give genuinely informed consent to participate.  All named researchers in the study who 
will carry out the MINI will receive training for the interview and specific supervision by the 
research team that will help to manage any distress arising during the interview process. 
 
Viewing images related to self-harm in the computer-based tasks:  
Participants will be made fully aware that they will be shown images related to self-harm in 
the participant information sheet, when completing the online screening, and again during 
the telephone screening. They will also be required to demonstrate their willingness to view 
these images during the telephone/video screening, and so will expect to be shown these 
during the testing session. Participants will be made fully aware before beginning the testing 
that they do not have to complete the tasks if they feel uncomfortable or distressed.  
 
Risk of distress from bringing to mind self-harm-related images during the imagery 
manipulation (ImRS):  
The clinicians/researchers conducting the ImRS are trained in this technique and have 
experience in delivering it either or both in clinical and experimental settings, including the 
iMAGine study (IRAS: 19/SC/0275). Participants are instructed to bring to mind the images as 
it happens in their daily life but in a way that is tolerable (i.e., to “tune down the image” if 
needed). The ImRS session will always end with exposure to the new adaptive image. The 
clinicians/researchers are trained to check that participants' affect has returned to a positive 
state and if needed will also offer to complete a positive imagery task shown to improve 
mood. At the end of the session there will be a debrief to ensure participants are okay before 
leaving. The researchers will be trained to make sure the session ends with the participant 
feeling supported and endowed with the necessary coping strategies in place to go safely back 
to their home.  
 
A participant disclosing information relevant to their health and safety such as suicidal risk, or 
the safety of others, will be addressed in the following ways:  
In session, adequately assess the mental state and risk of the participant once information 
suggesting these may be problematic is disclosed. 

 
 
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Assess current acute severe suicide ideation by asking whether questions C4, C5 and C6 
(suicidality section) in the MINI have applied to participants during the past week. 
The researcher will call the clinician supervising the testing to assess the participant and 
advise on further actions, including whether the participant can participate in the remainder 
of the study. Any review conducted by one of the covering clinicians will be documented in 
the participant’s study file. 
 
In session, carry out all possible interventions to reassure, support, and reduce active distress 
to the minimum 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; and/or informing via phone, 
email or letter the participant’s GP and/or other health professional (consultant psychiatrist, 
care coordinator etc.) named by the participant at the time of enrolment in the study 
(Screening visit). If the situation is deemed as needing urgent intervention, the mental health 
Single Point of Access service local to the participant will be contacted with a referral for 
urgent mental health assessment. 
 
All participants will be asked for their address and GP details at the start of the video-call 
screening, in case the participant is identified as high-risk, and the clinician needs to contact 
their GP. Participants will be informed that all information is confidential. The limits of 
confidentiality (e.g., that the researcher may have an ethical duty to disclose information to 
a third party to protect the immediate safety of the participant or someone else in the rare 
circumstance in which it is judged that the participant or someone else is at risk of serious 
harm) are made explicit to participants in both the participant information sheet and the 
consent form. 
 
Procedures have been developed based on comments (e.g., that we will need to minimise 
negative emotions after showing self-harm images), feedback and suggestions (e.g., to 
include a debrief), from the iMAGine/PsiloIMAGINE Young Person’s Research Groups. The 
group included in total 10 young people with lived experience of self-harm and other mental 
health issues. The group has approved the final protocol and study material.  
 
9.5. 
Benefits 
In our study participants take part in an experimental manipulation that is based on a 
cognitive behaviour therapy technique (imagery re-scripting) that has been shown to be 
beneficial as a single intervention or brief intervention with different mental health disorders, 
including initial evidence with self-harm (Sosic-Vasic & Schaitz, 2020). While this study does 
not provide a therapeutic context, it is possible that some participants may benefit 
temporarily or even long-term, by using the technique provided during the experimental 
manipulation, in their everyday lives to cope when self-harm-related mental imagery is 
present.  
 
No previous study has used psychedelics in the context of self-harm behaviour, so we are 
unable to say if augmenting imagery re-scripting with psilocybin will have beneficial effects. 

 
 
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Current literature using psychedelics in a therapeutic/experimental setting for other mental 
health disorders and maladaptive behaviours indicates that there may be some therapeutic 
benefit for participants from taking part. Hence participants randomised to psilocybin may 
experience improvements in various aspects of mental wellbeing in relation to or even 
regardless of the imagery-re scripting procedure. 
 
All participants will take part in "integration sessions" after the experimental manipulation 
that can improve emotional awareness and understanding of triggers and mechanism 
underpinning self-harm. 
 
Finally, while there may also be no personal benefit at all, participants may feel a sense of 
reward for helping us improve our understanding of self-harm behaviour in young people and 
develop better treatments for self-harm. 
 
9.6. 
Participant Reimbursement 
Participants will be reimbursed for time dedicated to study assessments at an approximate 
rate of 10£/hr, i.e., £150 in total, based on previous similar experimental studies conducted 
by the team. 
 
9.7. 
Consent 
Consent to enter the study must be sought from each participant only after a full explanation 
has been given, an information leaflet offered, and time allowed for consideration.  Signed 
participant consent should be obtained.  The right of the participant to refuse to participate 
without giving reasons must 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 are free to withdraw at any time from the 
protocol treatment without giving reasons and without prejudicing further treatment. 
 
Participants are provided with information about the broad aims of the study, what 
participation entails, rights to withdraw and terms of confidentiality and data protection. It is 
clearly stated that the participant is free to withdraw from the study at any time for any 
reason with no obligation to give the reason for withdrawal. The participant is allowed as 
much time as needed to consider the information, and the opportunity to question the 
researchers, their GP, other clinicians involved in their care, or other independent parties to 
decide whether they will participate in the study.  
 
Consent to participate in the online screening is given by a tick box before completing the 
online screening questionnaire. When testing is conducted in person, written Informed 
Consent is then obtained before the testing session by means of the participant’s dated 
signature, and signature of the person who presented informed consent. A copy of the signed 
Informed Consent form is given to the participant. The original signed form is retained at the 
study site. Informed consent also includes consent to inform referring clinicians about 
participation in the study and risk management procedures, which include breaking 

 
 
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confidentiality. Finally, participants will be given the option to also consent to being contacted 
for future studies at Imperial College London. 
9.8. 
Confidentiality 
The Chief Investigator will preserve the confidentiality of participants taking part in the study 
and is registered under the Data Protection Act. 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 the participant’s GP or other indicated health professional (as detailed 
above). 
Data will be pseudonymised (see below). 
 
9.9. 
Data Handling and Record Keeping 
All data will be pseudonymised. A study-specific participant ID number will identify the 
participant. The name and any other detail will not be included in any study electronic 
database compiled for statistical analysis of the research outcomes. Electronic data will be 
stored on network drives on the Imperial College server.  
A document matching identity and participant ID number is centrally managed by the 
research team and only accessed by named research team members on an encrypted server. 
Only named researchers will have access to the database that holds the personal information 
to access contact details while taking part in the study.  
Paper-based consent forms and participant questionnaires will be stored at the Division of 
Psychiatry, Imperial College London in separate locked cabinets. All documents are stored 
securely and only accessible by study staff and authorised personnel.  
 
Data from the questionnaires will be collected using Qualtrics, a research data collection 
platform (https://www.qualtrics.com/uk/). This data will be stored on a server owned by 
Qualtrics, whose data storage is compliant with OECD privacy rules and the European Union 
Directive on Data Protection. Data will be downloaded from Qualtrics and later stored on 
Imperial College London secure servers. This data will also be stored in a pseudonymised 
format with the participant ID. 
 
The data collected by the MindCraft app will be transferred directly from the app to the secure 
data server located in Imperial College data center only accessed by the research team. This 
data will also be stored in a pseudonymised format and will be linked to the Qualtrics 
collected data using the participant ID.   
 
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 in appropriate data 
archive facilities provided by Imperial College London. Named researchers will have sole 
access to the data over this time period.  
 

 
 
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The named research team will undertake analysis of the data from the study. This analysis 
will take place at the Division of Psychiatry, Imperial College London. Pseudonymised data will 
be made available to other researchers after the end of the study via data repositories such 
as Open Science Framework. 
22. 
 
 
9.10. Indemnity  
Imperial College London holds negligent harm and non-negligent harm insurance policies 
which apply to this study, which apply to this study.  
 
9.11. 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. 
 
9.12. Funding  
Financing will be provided by the London Interdisciplinary Social Science Doctoral Training 
Partnership. 
Individual researchers will not receive any personal payment over and above normal salary, 
or any other benefits or incentives, for taking part in this research.  
 
9.13. 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. 
 
 
10. STUDY MANAGEMENT  
The management of the study will be co-ordinated through Dr Martina Di Simplicio assisted 
by Prof David Nutt. Ms Ioanna Vamvakopoulou and Dr Bhavika Dulab will oversee the day-to-
day running of the project. Dr Balasundaram Kadirvelu will oversee the technical aspects of 
data collection from the MindCraft app.  
 
 
11. PUBLICATION POLICY  
The results from this study may be reported and disseminated through peer-reviewed 
journals, conference presentations, and publications on websites including a summary on the 
Imperial website and other innovative methods. 
 
 
 
 
 
 
 

 
 
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12. REFERENCES  
 
Adamson, S. J., Kay-Lambkin, F. J., Baker, A. L., Lewin, T. J., Thornton, L., Kelly, B. J., & Sellman, 
J. D. (2010). An improved brief measure of cannabis misuse: The Cannabis Use 
Disorders Identification Test-Revised (CUDIT-R). Drug and Alcohol Dependence, 110, 
137-143. https://doi.org/10.1016/J.DRUGALCDEP.2010.02.017  
Antony, M. M., Bieling, P. J., Cox, B. J., Enns, M. W., & Swinson, R. P. (1998). Psychometric 
properties of the 42-item and 21-item versions of the Depression Anxiety Stress Scales 
in clinical groups and a community sample. Psychological Assessment, 10(2), 176-181. 
https://doi.org/10.1037/1040-3590.10.2.176  
Barrett, F. S., Bradstreet, M. P., Leoutsakos, J. M. S., Johnson, M. W., & Griffiths, R. R. (2016). 
The Challenging Experience Questionnaire: Characterization of challenging 
experiences 
with 
psilocybin 
mushrooms. 
http://dx.doi.org/10.1177/0269881116678781, 
30, 
1279-1295. 
https://doi.org/10.1177/0269881116678781  
Barrett, F. S., Johnson, M. W., & Griffiths, R. R. (2015). Validation of the revised Mystical 
Experience Questionnaire in experimental sessions with psilocybin. Journal of 
psychopharmacology, 
29, 
1182-1190. 
https://doi.org/10.1177/0269881115609019/ASSET/IMAGES/LARGE/10.1177_02698
81115609019-FIG2.JPEG  
Carhart-Harris, R. L., Bolstridge, M., Day, C. M. J., Rucker, J., Watts, R., Erritzoe, D. E., Kaelen, 
M., Giribaldi, B., Bloomfield, M., Pilling, S., Rickard, J. A., Forbes, B., Feilding, A., Taylor, 
D., Curran, H. V., & Nutt, D. J. (2018). Psilocybin with psychological support for 
treatment-resistant depression: six-month follow-up. Psychopharmacology, 235, 399-
408. https://doi.org/10.1007/s00213-017-4771-x  
Carhart-Harris, R. L., Bolstridge, M., Rucker, J., Day, C. M. J., Erritzoe, D., Kaelen, M., 
Bloomfield, M., Rickard, J. A., Forbes, B., Feilding, A., Taylor, D., Pilling, S., Curran, V. 
H., & Nutt, D. J. (2016). Psilocybin with psychological support for treatment-resistant 
depression: an open-label feasibility study. The Lancet Psychiatry, 3, 619-627. 
https://doi.org/10.1016/S2215-0366(16)30065-7  
Carhart-Harris, R. L., King, L. A., & Nutt, D. J. (2011). A web-based survey on mephedrone. 
Drug 
Alcohol 
Depend., 
118(1), 
19-22. 
https://doi.org/10.1016/j.drugalcdep.2011.02.011  
Carhart-Harris, R. L., & Nutt, D. J. (2010). User perceptions of the benefits and harms of 
hallucinogenic drug use: A web-based questionnaire study. Journal of Substance Use, 
15(4), 283-300. https://doi.org/10.3109/14659890903271624  
Carter, O. L., Burr, D. C., Pettigrew, J. D., Wallis, G. M., Hasler, F., & Vollenweider, F. X. (2005). 
Using psilocybin to investigate the relationship between attention, working memory, 
and the serotonin 1A and 2A receptors. Journal of Cognitive neuroscience, 17(10), 
1497-1508.  
Carter, O. L., Pettigrew, J. D., Burr, D. C., Alais, D., Hasler, F., & Vollenweider, F. X. (2004). 
Psilocybin impairs high-level but not low-level motion perception. Neuroreport, 
15(12), 1947-1951.  

 
 
44 
                                                                                                  PsiloIMAGINE Study 
Protocol 
IRAS ID: 330839 
Version 1.1, Date 12.06.24          
Constantinou, N., Morgan, C. J., Battistella, S., O’Ryan, D., Davis, P., & Curran, H. V. (2010). 
Attentional bias, inhibitory control and acute stress in current and former opiate 
addicts. Drug and Alcohol Dependence, 109(1-3), 220-225.  
Cyders, M. A., Littlefield, A. K., Coffey, S., & Karyadi, K. A. (2014). Examination of a short 
English version of the UPPS-P Impulsive Behavior Scale. Addictive Behaviors, 39, 1372-
1376. https://doi.org/10.1016/J.ADDBEH.2014.02.013  
Di Simplicio, M., Appiah‐Kusi, E., Wilkinson, P., Watson, P., Meiser‐Stedman, C., Kavanagh, D. 
J., & Holmes, E. A. (2020). Imaginator: A proof‐of‐concept feasibility trial of a brief 
imagery‐based psychological intervention for young people who self‐Harm. Suicide 
and Life‐Threatening Behavior, 50(3), 724-740.  
Dombrovski, A. Y., Clark, L., Siegle, G. J., Butters, M. A., Ichikawa, N., Sahakian, B. J., & Szanto, 
K. (2010). Reward/punishment reversal learning in older suicide attempters. American 
Journal of Psychiatry, 167(6), 699-707.  
Doss, M. K., Považan, M., Rosenberg, M. D., Sepeda, N. D., Davis, A. K., Finan, P. H., Smith, G. 
S., Pekar, J. J., Barker, P. B., & Griffiths, R. R. (2021). Psilocybin therapy increases 
cognitive and neural flexibility in patients with major depressive disorder. 
Translational psychiatry, 11(1), 574.  
Erritzoe, D., Roseman, L., Nour, M., MacLean, K., Kaelen, M., Nutt, D., & Carhart‐Harris, R. 
(2018). Effects of psilocybin therapy on personality structure. Acta Psychiatrica 
Scandinavica, 138(5), 368-378.  
Ersche, K. D., Lim, T.-V., Ward, L. H. E., Robbins, T. W., & Stochl, J. (2017). Creature of Habit: 
A self-report measure of habitual routines and automatic tendencies in everyday life. 
Personality 
and 
Individual 
Differences, 
116, 
73-85. 
https://doi.org/https://doi.org/10.1016/j.paid.2017.04.024  
Felitti, V. J., Anda, R. F., Nordenberg, D., Williamson, D. F., Spitz, A. M., Edwards, V., Koss, M. 
P., & Marks, J. S. (1998). Relationship of Childhood Abuse and Household Dysfunction 
to Many of the Leading Causes of Death in Adults: The Adverse Childhood Experiences 
(ACE) 
Study. 
American 
Journal 
of 
Preventive 
Medicine, 
14, 
245-258. 
https://doi.org/10.1016/S0749-3797(98)00017-8  
Gard, D. E., Gard, M. G., Kring, A. M., & John, O. P. (2006). Anticipatory and consummatory 
components of the experience of pleasure: A scale development study. Journal of 
Research in Personality, 40, 1086-1102. https://doi.org/10.1016/J.JRP.2005.11.001  
Geulayov, G., Casey, D., McDonald, K. C., Foster, P., Pritchard, K., Wells, C., Clements, C., 
Kapur, N., Ness, J., & Waters, K. (2018). Incidence of suicide, hospital-presenting non-
fatal self-harm, and community-occurring non-fatal self-harm in adolescents in 
England (the iceberg model of self-harm): a retrospective study. The Lancet Psychiatry, 
5(2), 167-174.  
Gillies, D., Christou, M. A., Dixon, A. C., Featherston, O. J., Rapti, I., Garcia-Anguita, A., Villasis-
Keever, M., Reebye, P., Christou, E., Al Kabir, N., & Christou, P. A. (2018). Prevalence 
and Characteristics of Self-Harm in Adolescents: Meta-Analyses of Community-Based 
Studies 1990–2015. Journal of the American Academy of Child & Adolescent 
Psychiatry, 57, 733-741.  
Glenn, C. R., Esposito, E. C., Porter, A. C., & Robinson, D. J. (2019). Evidence base update of 
psychosocial treatments for self-injurious thoughts and behaviors in youth. Journal of 
Clinical Child & Adolescent Psychology, 48(3), 357-392.  

 
 
45 
                                                                                                  PsiloIMAGINE Study 
Protocol 
IRAS ID: 330839 
Version 1.1, Date 12.06.24          
Goodwin, G. M., Aaronson, S. T., Alvarez, O., Arden, P. C., Baker, A., Bennett, J. C., Bird, C., 
Blom, R. E., Brennan, C., & Brusch, D. (2022). Single-dose psilocybin for a treatment-
resistant episode of major depression. New England Journal of Medicine, 387(18), 
1637-1648.  
Gouzoulis-Mayfrank, E., Thelen, B., Habermeyer, E., Kunert, H., Kovar, K.-A., Lindenblatt, H., 
Hermle, L., Spitzer, M., & Sass, H. (1999). Psychopathological, neuroendocrine and 
autonomic effects of 3, 4-methylenedioxyethylamphetamine (MDE), psilocybin and d-
methamphetamine in healthy volunteers Results of an experimental double-blind 
placebo-controlled study: Results of an experimental double-blind placebo-controlled 
study. Psychopharmacology, 142, 41-50.  
Griffiths, R., Richards, W., Johnson, M., McCann, U., & Jesse, R. (2008). Mystical-type 
experiences occasioned by psilocybin mediate the attribution of personal meaning 
and spiritual significance 14 months later. J Psychopharmacol., 22(6), 621-632. 
https://doi.org/10.1177/0269881108094300  
Griffiths, R. R., Johnson, M. W., Carducci, M. A., Umbricht, A., Richards, W. A., Richards, B. D., 
Cosimano, M. P., & Klinedinst, M. A. (2016). Psilocybin produces substantial and 
sustained decreases in depression and anxiety in patients with life-threatening cancer: 
A randomized double-blind trial. J Psychopharmacol, 30(12), 1181-1197. 
https://doi.org/10.1177/0269881116675513  
Griffiths, R. R., Johnson, M. W., Richards, W. A., Richards, B. D., McCann, U., & Jesse, R. (2011). 
Psilocybin occasioned mystical-type experiences: immediate and persisting dose-
related 
effects. 
Psychopharmacology 
(Berl), 
218(4), 
649-665. 
https://doi.org/10.1007/s00213-011-2358-5  
Grob, C. S., Danforth, A. L., Chopra, G. S., Hagerty, M., McKay, C. R., Halberstadt, A. L., & Greer, 
G. R. (2011). Pilot study of psilocybin treatment for anxiety in patients with advanced-
stage 
cancer. 
Arch 
Gen 
Psychiatry, 
68(1), 
71-78. 
https://doi.org/10.1001/archgenpsychiatry.2010.116  
Grob, C. S., Poland, R. E., Chang, L., & Ernst, T. (1996). Psychobiologic effects of 3,4-
methylenedioxymethamphetamine in humans: methodological considerations and 
preliminary 
observations. 
Behav 
Brain 
Res., 
73(1-2), 
103-107. 
https://doi.org/10.1016/0166-4328(96)00078-2  
Hales, S. A., Deeprose, C., Goodwin, G. M., & Holmes, E. A. (2011). Cognitions in bipolar 
affective disorder and unipolar depression: imagining suicide. Bipolar Disord, 13(7-8), 
651-661. https://doi.org/10.1111/j.1399-5618.2011.00954.x  
Hallion, L. S., Steinman, S. A., Tolin, D. F., & Diefenbach, G. J. (2018). Psychometric Properties 
of the Difficulties in Emotion Regulation Scale (DERS) and Its Short Forms in Adults 
With 
Emotional 
Disorders. 
Frontiers 
in 
Psychology, 
9. 
https://doi.org/10.3389/fpsyg.2018.00539  
Hasking, P. A., Di Simplicio, M., McEvoy, P. M., & Rees, C. S. (2018). Emotional cascade theory 
and non-suicidal self-injury: the importance of imagery and positive affect. Cognition 
and Emotion, 32(5), 941-952.  
Hasler, F., Grimberg, U., Benz, M. A., Huber, T., & Vollenweider, F. X. (2004). Acute 
psychological and physiological effects of psilocybin in healthy humans: a double-
blind, placebo-controlled dose?effect study. Psychopharmacology, 172(2), 145-156. 
https://dx.doi.org/10.1007/s00213-003-1640-6  

 
 
46 
                                                                                                  PsiloIMAGINE Study 
Protocol 
IRAS ID: 330839 
Version 1.1, Date 12.06.24          
Hassabis, D., Kumaran, D., & Maguire, E. A. (2007). Using imagination to understand the 
neural basis of episodic memory. Journal of neuroscience, 27(52), 14365-14374.  
Hollister, L. E. (1961). Clinical, biochemical and psychologic effects of psilocybin. Arch Int 
Pharmacodyn Ther, 130, 42-52.  
Holmes, E. A., Arntz, A., & Smucker, M. R. (2007). Imagery rescripting in cognitive behaviour 
therapy: Images, treatment techniques and outcomes. Journal of behavior therapy 
and experimental psychiatry, 38(4), 297-305.  
Holmes, E. A., Craske, M. G., & Graybiel, A. M. (2014). Psychological treatments: A call for 
mental-health science. Nature, 511(7509), 287-289.  
Ji, J. L., Kavanagh, D. J., Holmes, E. A., MacLeod, C., & Di Simplicio, M. (2019). Mental imagery 
in psychiatry: conceptual & clinical implications. CNS spectrums, 24(1), 114-126.  
Johnson, M., Richards, W., & Griffiths, R. (2008). Human hallucinogen research: guidelines for 
safety. 
J 
Psychopharmacol, 
22(6), 
603-620. 
https://doi.org/10.1177/0269881108093587  
Kadirvelu, B., Bellido Bel, T., Wu, X., Burmester, V., Ananth, S., Cabral, C. C. B. B., Girela-
Serrano, B., Gledhill, J., Di Simplicio, M., Nicholls, D., & Faisal, A. A. (2023). Mindcraft, 
a Mobile Mental Health Monitoring Platform for Children and Young People: 
Development and Acceptability Pilot Study. JMIR Form Res, 7, e44877. 
https://doi.org/10.2196/44877  
Kavanagh, D. J., Andrade, J., & May, J. (2005). Imaginary relish and exquisite torture: the 
elaborated intrusion theory of desire. Psychological review, 112(2), 446.  
Knäuper, B., McCollam, A., Rosen-Brown, A., Lacaille, J., Kelso, E., & Roseman, M. (2011). 
Fruitful plans: Adding targeted mental imagery to implementation intentions 
increases fruit consumption. Psychology and Health, 26(5), 601-617.  
Kometer, M., Schmidt, A., Jäncke, L., & Vollenweider, F. X. (2013). Activation of serotonin 2A 
receptors underlies the psilocybin-induced effects on α oscillations, N170 visual-
evoked potentials, and visual hallucinations. Journal of neuroscience, 33(25), 10544-
10551.  
Kosslyn, S. M., Ganis, G., & Thompson, W. L. (2001). Neural foundations of imagery. Nature 
reviews neuroscience, 2(9), 635-642.  
Loijen, A., Vrijsen, J. N., Egger, J. I., Becker, E. S., & Rinck, M. (2020). Biased approach-
avoidance tendencies in psychopathology: A systematic review of their assessment 
and modification. Clinical psychology review, 77, 101825.  
McKenna, D. J., Repke, D. B., Lo, L., & Peroutka, S. J. (1990). Differential interactions of 
indolealkylamines with 5-hydroxytryptamine receptor subtypes. Neuropharmacology, 
29(3), 193-198.  
McManus, S., Gunnell, D., Cooper, C., Bebbington, P. E., Howard, L. M., Brugha, T., Jenkins, R., 
Hassiotis, A., Weich, S., & Appleby, L. (2019). Prevalence of non-suicidal self-harm and 
service contact in England, 2000–14: repeated cross-sectional surveys of the general 
population. The Lancet Psychiatry, 6(7), 573-581.  
Moreno, F. A., Wiegand, C. B., Taitano, K., & Delgado, P. L. (2006). Safety, Tolerability, and 
Efficacy of Psilocybin in 9 Patients With Obsessive-Compulsive Disorder | 
Psychiatrist.com. 
The 
Journal 
of 
Clinical 
Psychiatry, 
1735-1740. 
https://doi.org/10.4088/jcp.v67n1110  

 
 
47 
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Protocol 
IRAS ID: 330839 
Version 1.1, Date 12.06.24          
Morgan, C., Webb, R. T., Carr, M. J., Kontopantelis, E., Green, J., Chew-Graham, C. A., Kapur, 
N., & Ashcroft, D. M. (2017). Incidence, clinical management, and mortality risk 
following self harm among children and adolescents: cohort study in primary care. 
bmj, 359.  
Morgan, C. J., Muetzelfeldt, L., Muetzelfeldt, M., Nutt, D. J., & Curran, H. V. (2010). Harms 
associated with psychoactive substances: findings of the UK National Drug Survey. J 
Psychopharmacol, 24(2), 147-153. https://doi.org/10.1177/0269881109106915  
Moscovitch, D. A., Gavric, D. L., Merrifield, C., Bielak, T., & Moscovitch, M. (2011). Retrieval 
properties of negative vs. positive mental images and autobiographical memories in 
social anxiety: Outcomes with a new measure. Behaviour Research and Therapy, 49(8), 
505-517. https://doi.org/https://doi.org/10.1016/j.brat.2011.05.009  
Neff, K. D. (2003). The Development and Validation of a Scale to Measure Self-Compassion. 
Self and Identity, 2(3), 223-250. https://doi.org/10.1080/15298860309027  
Nelson, H. E., & Willison, J. R. (1991). The revised national adult reading test–test manual. 
Windsor: Nfer-Nelson(991), pp.1-6.  
Nichols, D. E. (2004). Hallucinogens. Pharmacology & therapeutics, 101(2), 131-181.  
Nixon, M. K., Cloutier, P. F., & Aggarwal, S. (2002). Affect regulation and addictive aspects of 
repetitive self-injury in hospitalized adolescents. Journal of the American Academy of 
Child & Adolescent Psychiatry, 41(11), 1333-1341.  
Nock, M. K., Holmberg, E. B., Photos, V. I., & Michel, B. D. (2007). Self-Injurious Thoughts and 
Behaviors Interview: Development, reliability, and validity in an adolescent sample. 
Psychological 
Assessment, 
19(3), 
309-317. 
https://doi.org/10.1037/1040-
3590.19.3.309  
Nock, M. K., & Prinstein, M. J. (2005). Contextual features and behavioral functions of self-
mutilation among adolescents. Journal of Abnormal Psychology, 114, 140-146.  
Nord, C. L., Longley, B., Dercon, Q., Phillips, V., Funk, J., Gormley, S., Knight, R., Smith, A. J., & 
Dalgleish, T. (2023). A transdiagnostic meta-analysis of acute augmentations to 
psychological therapy. Nature Mental Health, 1-13.  
Nutt, D., King, L. A., Saulsbury, W., & Blakemore, C. (2007). Development of a rational scale 
to assess the harm of drugs of potential misuse. Lancet., 369(9566), 1047-1053. 
https://doi.org/10.1016/s0140-6736(07)60464-4  
Nutt, D. J., King, L. A., & Phillips, L. D. (2010). Drug harms in the UK: a multicriteria decision 
analysis. 
Lancet., 
376(9752), 
1558-1565. 
https://doi.org/10.1016/s0140-
6736(10)61462-6  
O'Connor, R. C., Fraser, L., Whyte, M.-C., MacHale, S., & Masterton, G. (2008). A comparison 
of specific positive future expectancies and global hopelessness as predictors of 
suicidal ideation in a prospective study of repeat self-harmers. Journal of affective 
disorders, 110(3), 207-214.  
O'Donnell, C., Di Simplicio, M., Brown, R., Holmes, E. A., & Burnett Heyes, S. (2018). The role 
of mental imagery in mood amplification: An investigation across subclinical features 
of 
bipolar 
disorders. 
Cortex, 
105, 
104-117. 
https://doi.org/10.1016/j.cortex.2017.08.010  
O’Connor, R. C., O’Carroll, R. E., Ryan, C., & Smyth, R. (2012). Self-regulation of unattainable 
goals in suicide attempters: A two year prospective study. Journal of affective 
disorders, 142(1-3), 248-255.  

 
 
48 
                                                                                                  PsiloIMAGINE Study 
Protocol 
IRAS ID: 330839 
Version 1.1, Date 12.06.24          
Passie, T. (2005). A history of the use of psilocybin in psychotherapy. In R. Metzner (Ed.), 
Sacred Mushroom of Visions: Teonanácatl: A Sourcebook on the Psilocybin Mushroom 
(pp. 113-138). Park Street Press.  
Passie, T., Seifert, J., Schneider, U., & Emrich, H. M. (2002). The pharmacology of psilocybin. 
Addiction biology, 7(4), 357-364.  
Robinson, N., Kavanagh, D., Connor, J., May, J., & Andrade, J. (2016). Assessment of 
motivation to control alcohol use: The motivational thought frequency and state 
motivation 
scales 
for 
alcohol 
control. 
Addictive 
Behaviors, 
59, 
1-6. 
https://doi.org/10.1016/J.ADDBEH.2016.02.038  
Rodrigues, R., Mehesz, E. Z., Lingford-Hughes, A., & Di Simplicio, M. (2023). Approach-
avoidance biases to self-harm cues in young people with self-harm. Journal of affective 
disorders, 340, 435-441. https://doi.org/https://doi.org/10.1016/j.jad.2023.08.021  
Roseman, L., Demetriou, L., Wall, M. B., Nutt, D. J., & Carhart-Harris, R. L. (2018). Increased 
amygdala responses to emotional faces after psilocybin for treatment-resistant 
depression. Neuropharmacology, 142, 263-269.  
Roseman, L., Haijen, E., Idialu-Ikato, K., Kaelen, M., Watts, R., & Carhart-Harris, R. (2019). 
Emotional breakthrough and psychedelics: Validation of the Emotional Breakthrough 
Inventory. 
Journal 
of 
psychopharmacology, 
33, 
1076-1087. 
https://doi.org/10.1177/0269881119855974/ASSET/IMAGES/LARGE/10.1177_02698
81119855974-FIG2.JPEG  
Saunders, J. B., Aasland, O. G., Babor, T. F., De La Fuente, J. R., & Grant, M. (1993). 
Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO 
Collaborative Project on Early Detection of Persons with Harmful Alcohol 
Consumption-II. 
Addiction, 
88, 
791-804. 
https://doi.org/10.1111/J.1360-
0443.1993.TB02093.X  
Saunders, K., & Smith, K. (2016). Interventions to prevent self-harm: what does the evidence 
say? Evidence-based mental health, 19(3).  
Schaitz, C., Kroener, J., Maier, A., Connemann, B. J., & Sosic-Vasic, Z. (2020). Short imagery 
rescripting intervention to treat emotionally dysregulated behavior in borderline 
personality disorder: an exploratory study. Frontiers in Psychiatry, 11, 425.  
Sheehan, D., Janavs, J., Baker, R., Sheehan, K., Knapp, E., & Sheehan, M. (2016). The MINI 
international neuropsychiatric interview (Version 7.0. 2) for DSM-5. Harm Research 
Institute.  
Sosic-Vasic, Z., & Schaitz, C. (2020). New ways in dealing with emotional dysregulation in 
borderline personality disorder? feasibility of a new short intervention of imagery 
rescripting. European Psychiatry, 63.  
Spielberger, C. D., Gorsuch, R. L., Lushene, R., Vagg, P. R., & Jacobs, G. A. (1983). Manual for 
the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press.  
Strachan, L. P., Hyett, M. P., & McEvoy, P. M. (2020). Imagery rescripting for anxiety disorders 
and obsessive-compulsive disorder: recent advances and future directions. Current 
Psychiatry Reports, 22, 1-8.  
Studerus, E., Kometer, M., Hasler, F., & Vollenweider, F. X. (2011). Acute, subacute and long-
term subjective effects of psilocybin in healthy humans: a pooled analysis of 
experimental 
studies. 
J 
Psychopharmacol, 
25(11), 
1434-1452. 
https://doi.org/10.1177/0269881110382466  

 
 
49 
                                                                                                  PsiloIMAGINE Study 
Protocol 
IRAS ID: 330839 
Version 1.1, Date 12.06.24          
Studerus, E., Kometer, M., Hasler, F., & Vollenweider, F. X. (2011). Acute, subacute and long-
term subjective effects of psilocybin in healthy humans: a pooled analysis of 
experimental studies. Journal of Psychopharmacology, 25(11), 1434-1452.  
Teresi, J. A., Yu, X., Stewart, A. L., & Hays, R. D. (2022). Guidelines for Designing and Evaluating 
Feasibility 
Pilot 
Studies. 
Medical 
Care, 
60(1), 
95-103. 
https://doi.org/10.1097/mlr.0000000000001664  
van Amsterdam, J., & van den Brink, W. (2010). Ranking of drugs: a more balanced risk-
assessment. 
Lancet., 
376(9752), 
1524-1525. 
https://doi.org/10.1016/s0140-
6736(10)62000-4  
Vollenweider, F. X., Vollenweider-Scherpenhuyzen, M. F., Bäbler, A., Vogel, H., & Hell, D. 
(1998). Psilocybin induces schizophrenia-like psychosis in humans via a serotonin-2 
agonist action. Neuroreport, 9(17), 3897-3902.  
Washburn, J. J., Juzwin, K. R., Styer, D. M., & Aldridge, D. (2010). Measuring the urge to self-
injure: Preliminary data from a clinical sample. Psychiatry Research, 178, 540-544. 
https://doi.org/10.1016/J.PSYCHRES.2010.05.018  
Watson, R., McCabe, C., Harvey, K., & Reynolds, S. (2021). Development and validation of a 
new adolescent self-report scale to measure loss of interest and pleasure: The 
Anhedonia Scale for Adolescents. Psychological assessment, 33, 201-217. 
https://doi.org/10.1037/PAS0000977  
Wittmann, M., Carter, O., Hasler, F., Cahn, B. R., Grimberg, U., Spring, P., Hell, D., Flohr, H., & 
Vollenweider, F. X. (2007). Effects of psilocybin on time perception and temporal 
control 
of 
behaviour 
in 
humans. 
J 
Psychopharmacol, 
21(1), 
50-64. 
https://doi.org/10.1177/0269881106065859  
Young, J. E. (1994). Cognitive therapy for personality disorders: A schema-focused approach, 
Rev. ed. Professional Resource Press/Professional Resource Exchange.  
Zanarini, M. C., Vujanovic, A. A., Parachini, E. A., Boulanger, J. L., Frankenburg, F. R., & Hennen, 
J. (2003). A screening measure for BPD: The Mclean Screening Instrument for 
Borderline Personality Disorder (MSI-BPD). Journal of Personality Disorders, 17(6), 
568-573. https://doi.org/10.1521/pedi.17.6.568.25355