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

ConditionSelf Harm
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age16-25
SponsorImperial College London

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 2 lifetime episodes of self-harm measured using the Self-Injurious Thoughts and Behaviours Interview (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 (Hales et al., 2011)

Any gender

Age: 16-25 years old

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psilocybin 5 mg with cognitive behavioural therapy intervention

    Drug

    This is an oral 5mg psilocybin dose preceding a mental imagery rescripting procedure

  • Placebo with cognitive behavioural therapy intervention

    Drug

    This is an oral placebo comparator preceding a mental imagery rescripting procedure

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Psilocybin 5mgExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

Difficulty in Emotional Regulation

Scores on the Difficulty in Emotional Regulation Scale (Hallion et al., 2018)

Time frame
Up to 5 months

Other outcomes

Sponsors and contacts

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