Actively Recruiting

Early Phase 1
Age: 16Years - 25Years
All Genders
NCT06798636

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

Led by Imperial College London · Updated on 2025-12-05

30

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 16Years - 25Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 2 lifetime episodes of self-harm with at least 1 episode in the past month
  • Self-harm-associated mental imagery in the past 6 weeks
  • Any gender
  • Age between 16 and 25 years old
  • Good command of the English language
  • Mental capacity to provide written informed consent
  • Willingness to engage in tasks showing images of self-harm
  • Willingness to discuss mental health and self-harm behavior
  • Normal ECG and blood pressure as determined by study medical staff
  • No previous psychedelic drug use
  • No recreational drug use within 7 days before dosing visit
  • Comfortable using a computer and smartphone app for data collection
  • Access to internet at home and willingness to have some study visits via video-link
Not Eligible

You will not qualify if you...

  • Current or past psychosis or mania in participant or first-degree relative
  • Severe suicidal thoughts posing participation risk
  • Medically significant conditions unsuitable for psychedelic use (e.g., hypertension, diabetes, severe cardiovascular disease, liver or kidney failure)
  • Previous psychedelic use
  • Current or chronic kidney or liver disease
  • History of serious adverse reactions to psychedelics
  • Intoxication during visits (difficulty walking, slurred speech, drowsiness)
  • Clinically significant head injury contraindicating participation
  • Severe learning disabilities requiring support for daily tasks
  • Unwillingness or inability to follow study procedures
  • Current use of psychoactive medications
  • History of psychosurgery
  • Unlikely to comply with study protocol and lifestyle restrictions
  • Unstable physical illness
  • Heavy smoking
  • Need for medications that could interact with psilocybin (e.g., SSRIs, certain antidepressants, some analgesics, MAOIs, antipsychotics)
  • Unwillingness to inform GP or mental health practitioners of participation
  • Women of childbearing age not using reliable contraception or unable to comply with pregnancy testing requirements

AI-Screening

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Trial Site Locations

Total: 1 location

1

Imperial College London

London, United Kingdom

Actively Recruiting

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Research Team

J

Joanna Vamvakopoulou

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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