NCT06798636

PsiloIMAGINE: A Psychedelic-augmented Mental Imagery-based Intervention for Young People With Self-harm

Investigating the Effects of a Psychedelic-augmented Mental Imagery-based Intervention for Young People With Self-harm Behaviour: an Experimental Medicine Study

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 16 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Self Harm

Interventions

Type	Name	Description
DRUG	Psilocybin 5 mg with cognitive behavioural therapy intervention	This is an oral 5mg psilocybin dose preceding a mental imagery rescripting procedure
DRUG	Placebo with cognitive behavioural therapy intervention	This is an oral placebo comparator preceding a mental imagery rescripting procedure

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-08-31
• Completion: 2026-10-31
• First posted: 2025-01-29
• Last updated: 2025-12-05

Locations

1 site across 1 country: United Kingdom