An Early Phase 1 interventional study of Psilocybin 5 mg with cognitive behavioural therapy intervention and Placebo with cognitive behavioural therapy intervention in Self Harm, sponsored by Imperial College London. Recruiting at 1 site in United Kingdom. Open to participants aged 16 Years to 25 Years. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Imperial College London · Early Phase 1, Interventional, and Other
Approximately 20% of young people experience self-harm behaviour in their lives. Self-harm can occur across different mental health disorders, and lead to negative outcomes and risk of suicide. Current treatments are long, costly and do not suit all young people, making it essential to research alternative treatments. Therapy combined with psychedelic drugs has recently been shown to be helpful in a variety of mental health disorders, including depression. This research project will explore the mechanisms by which combining a low dose of psychedelic psilocybin with a cognitive technique may target self-harm behaviour in young people (aged 16-25).
Previous research has shown that mental images of self-harm are common among individuals who self-harm and can increase the urge to self-harm. Imagery Re-Scripting (ImRS) is a cognitive technique that guides an individual to replace mental imagery driving self-harm with an alternative image that will instead discourage self-harm and promote alternative coping strategies. However, during ImRS individuals may fear bringing negative mental images and emotions to mind, hindering the process. Psychedelic substances can increase the ability to tolerate difficult emotions, make thinking styles more flexible and individuals more open to change. Based on this, the aim is to test if enhancing a cognitive technique with a low dose psychedelic can modify the cognitive mechanisms maintaining self- harm behaviour.
The aim is to examine the effect of a sub-hallucinogenic dose of psilocybin in combination with ImRS on cognitive processes, such as experiencing vivid mental images, and whether it can reduce these mental images and associated negative emotions in young people with recent self-harm behaviour above the effects of ImRS alone.
The hypothesis is that psilocybin could facilitate confronting the emotions that arise during ImRS and make it easier to generate new helpful mental imagery.
These experimental data could lay the foundation for future treatment development targeting self-harm in young people.
249 studies on the registry are indexed under Self-Injurious Behavior; 92 are open to participants now.
This study's planned enrollment of 30 is below the median of 66 across 212 interventional studies indexed under Self-Injurious Behavior.
Browse Self-Injurious Behavior studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be given orally one 5mg psilocybin capsule.
Drug: Psilocybin 5 mg with cognitive behavioural therapy intervention
Participants will be given orally one 25mg MCC inert placebo capsule.
Drug: Placebo with cognitive behavioural therapy intervention
This is an oral 5mg psilocybin dose preceding a mental imagery rescripting procedure
Also known as: Psilocybin
This is an oral placebo comparator preceding a mental imagery rescripting procedure
Frequency of mental imagery
Frequency scores on a 1-10 Likert scale related to self-harm and novel adaptive mental imagery
Time frame: Up to 3 months
Vividness of mental imagery
Vividness scores on a 1-10 Likert scale related to self-harm and novel adaptive mental imagery
Time frame: Up to 3 months
Intensity of emotions related to mental imagery
Emotions' intensity scores on a 1-10 Likert scale related to self-harm and novel adaptive mental imagery
Time frame: Up to 3 months
Believability of cognitions related to mental imagery
Cognitions' believability scores on a 1-10 Likert scale related to self-harm and novel adaptive mental imagery
Time frame: Up to 3 months
Schemas
Scores on Young Schema Questionnaire Short Form (Young et al., 1994)
Time frame: Up to 3 months
Approach Avoidance task
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)
Time frame: Up to 5 months
Probabilistic Reversal Learning Task
Performance (e.g., reaction time, accuracy, learning rate) on the Probabilistic Reversal Learning task (Dombrovski et al., 2010)
Time frame: Up to 5 months
Self-harm Dot Probe Task
Performance (e.g., reaction time, accuracy, learning rate) on the Self-harm Dot Probe Task (Constantinou et al., 2010)
Time frame: Up to 5 months
Difficulty in Emotional Regulation
Scores on the Difficulty in Emotional Regulation Scale (Hallion et al., 2018)
Time frame: Up to 5 months
Self-compassion
Scores on the Self-compassion scale (Neff, 2003)
Time frame: Up to 5 months
Motivation for Reducing Self-harm
Scores on the State Motivation for Reducing Self-harm scale (Robinson et al., 2016)
Time frame: Up to 5 months
Mystical Experience
Scores on the Mystical Experience questionnaire (Barrett et al., 2015)
Time frame: Up to 5 months
Challenging Psychedelic Experience
Scores on the Challenging Experience questionnaire (Barrett et al., 2016)
Time frame: Up to 5 months
Emotional Breakthrough
Scores on the Emotional Breakthrough inventory (EBI; Roseman et al., 2019)
Time frame: Up to 5 months
Attrition
Percentage of eligible enrolled participants completing outcome assessment
Time frame: Up to 5 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All non identifiable outcome measures will be shared.
Supporting information: Study protocol
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Imperial College London