Self HarmEarly Phase 1PsiloIMAGINENCT06798636
PsiloIMAGINE: A Psychedelic-augmented Mental Imagery-based Intervention for Young People With Self-harm
A Early Phase 1 study testing Psilocybin 5 mg with cognitive behavioural therapy intervention in people with Self Harm, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Self Harm
- What is being tested?
- Psilocybin 5 mg with cognitive behavioural therapy intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2025to 31 Oct 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
- Good command of the English language
- Mental capacity to provide written informed consent
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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 work/school tasks
- Unwillingness or inability to follow the procedures outlined in the protocol
- Are currently using a psychoactive medication
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College London
London
About this study
Official title: Investigating the Effects of a Psychedelic-augmented Mental Imagery-based Intervention for Young People With Self-harm Behaviour: an Experimental Medicine Study
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.
Read more
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
- Being tested
- Psilocybin 5 mg with cognitive behavioural therapy intervention, Placebo with cognitive behavioural therapy intervention
- Keywords
- Psilocybin, Psychedelic, Self injury, Self-Injurious Behaviour
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin 5 mg with cognitive behavioural therapy interventionDrug
Also called Psilocybin
This is an oral 5mg psilocybin dose preceding a mental imagery rescripting procedure
Placebo with cognitive behavioural therapy interventionDrug
This is an oral placebo comparator preceding a mental imagery rescripting procedure
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin 5mg | Experimental | Participants will be given orally one 5mg psilocybin capsule. Receives: Drug: Psilocybin 5 mg with cognitive behavioural therapy intervention |
| Placebo | Placebo comparator | Participants will be given orally one 25mg MCC inert placebo capsule. Receives: Drug: Placebo with cognitive behavioural therapy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of mental imagery
Frequency scores on a 1-10 Likert scale related to self-harm and novel adaptive mental imagery
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 3 months
Schemas
Scores on Young Schema Questionnaire Short Form (Young et al., 1994)
Measured: Up to 3 months
Secondary outcomes (10)
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)
Measured: 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)
Measured: 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)
Measured: Up to 5 months
Difficulty in Emotional Regulation
Scores on the Difficulty in Emotional Regulation Scale (Hallion et al., 2018)
Measured: Up to 5 months
Self-compassion
Scores on the Self-compassion scale (Neff, 2003)
Measured: Up to 5 months
Motivation for Reducing Self-harm
Scores on the State Motivation for Reducing Self-harm scale (Robinson et al., 2016)
Measured: Up to 5 months
Mystical Experience
Scores on the Mystical Experience questionnaire (Barrett et al., 2015)
Measured: Up to 5 months
Challenging Psychedelic Experience
Scores on the Challenging Experience questionnaire (Barrett et al., 2016)
Measured: Up to 5 months
Emotional Breakthrough
Scores on the Emotional Breakthrough inventory (EBI; Roseman et al., 2019)
Measured: Up to 5 months
Attrition
Percentage of eligible enrolled participants completing outcome assessment
Measured: Up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Oct 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Self HarmStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martina Di Simplicio, Dr, Principal investigator, Imperial College LondonDavid Nutt, Prof, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798636
- Sponsor's protocol ID
- 172441
- Other IDs
- IRAS ID: 330839
- Acronym
- PsiloIMAGINE
- Status last verified
- Nov 2025
- First submitted
- 14 Jan 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All non identifiable outcome measures will be shared.
Publications
Passie T, Guss J, Krahenmann R. Lower-dose psycholytic therapy - A neglected approach. Front Psychiatry. 2022 Dec 2;13:1020505. doi: 10.3389/fpsyt.2022.1020505. eCollection 2022.
PubMed 36532196Doss MK, Povazan M, Rosenberg MD, Sepeda ND, Davis AK, Finan PH, Smith GS, Pekar JJ, Barker PB, Griffiths RR, Barrett FS. Psilocybin therapy increases cognitive and neural flexibility in patients with major depressive disorder. Transl Psychiatry. 2021 Nov 8;11(1):574. doi: 10.1038/s41398-021-01706-y.
PubMed 34750350Erritzoe D, Roseman L, Nour MM, MacLean K, Kaelen M, Nutt DJ, Carhart-Harris RL. Effects of psilocybin therapy on personality structure. Acta Psychiatr Scand. 2018 Nov;138(5):368-378. doi: 10.1111/acps.12904. Epub 2018 Jun 19.
PubMed 29923178Roseman L, Demetriou L, Wall MB, Nutt DJ, Carhart-Harris RL. Increased amygdala responses to emotional faces after psilocybin for treatment-resistant depression. Neuropharmacology. 2018 Nov;142:263-269. doi: 10.1016/j.neuropharm.2017.12.041. Epub 2017 Dec 27.
PubMed 29288686Goodwin GM, Aaronson ST, Alvarez O, Arden PC, Baker A, Bennett JC, Bird C, Blom RE, Brennan C, Brusch D, Burke L, Campbell-Coker K, Carhart-Harris R, Cattell J, Daniel A, DeBattista C, Dunlop BW, Eisen K, Feifel D, Forbes M, Haumann HM, Hellerstein DJ, Hoppe AI, Husain MI, Jelen LA, Kamphuis J, Kawasaki J, Kelly JR, Key RE, Kishon R, Knatz Peck S, Knight G, Koolen MHB, Lean M, Licht RW, Maples-Keller JL, Mars J, Marwood L, McElhiney MC, Miller TL, Mirow A, Mistry S, Mletzko-Crowe T, Modlin LN, Nielsen RE, Nielson EM, Offerhaus SR, O'Keane V, Palenicek T, Printz D, Rademaker MC, van Reemst A, Reinholdt F, Repantis D, Rucker J, Rudow S, Ruffell S, Rush AJ, Schoevers RA, Seynaeve M, Shao S, Soares JC, Somers M, Stansfield SC, Sterling D, Strockis A, Tsai J, Visser L, Wahba M, Williams S, Young AH, Ywema P, Zisook S, Malievskaia E. Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. N Engl J Med. 2022 Nov 3;387(18):1637-1648. doi: 10.1056/NEJMoa2206443.
PubMed 36322843Holmes EA, Arntz A, Smucker MR. Imagery rescripting in cognitive behaviour therapy: images, treatment techniques and outcomes. J Behav Ther Exp Psychiatry. 2007 Dec;38(4):297-305. doi: 10.1016/j.jbtep.2007.10.007. Epub 2007 Oct 26.
PubMed 18035331Hasking PA, Di Simplicio M, McEvoy PM, Rees CS. Emotional cascade theory and non-suicidal self-injury: the importance of imagery and positive affect. Cogn Emot. 2018 Aug;32(5):941-952. doi: 10.1080/02699931.2017.1368456. Epub 2017 Aug 25.
PubMed 28838289Di Simplicio M, Appiah-Kusi E, Wilkinson P, Watson P, Meiser-Stedman C, Kavanagh DJ, Holmes EA. Imaginator: A Proof-of-Concept Feasibility Trial of a Brief Imagery-Based Psychological Intervention for Young People Who Self-Harm. Suicide Life Threat Behav. 2020 Jun;50(3):724-740. doi: 10.1111/sltb.12620. Epub 2020 Feb 14.
PubMed 32057131Ji JL, Kavanagh DJ, Holmes EA, MacLeod C, Di Simplicio M. Mental imagery in psychiatry: conceptual & clinical implications. CNS Spectr. 2019 Feb;24(1):114-126. doi: 10.1017/S1092852918001487. Epub 2019 Jan 28.
PubMed 30688194
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of a Psychedelic-augmented Mental Imagery-based Intervention for Young People With Self-harm Behaviour: an Experimental Medicine Study
- ClinicalTrials.gov ID
- NCT06798636
- Acronym / sponsor ID
- PsiloIMAGINE / 172441
- Conditions
- Self Harm
- Keywords
- Psilocybin, Psychedelic, Self injury, Self-Injurious Behaviour
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psilocybin 5mg | Experimental | Drug: Psilocybin 5 mg with cognitive behavioural therapy interventionParticipants will be given orally one 5mg psilocybin capsule. |
| Placebo | Placebo comparator | Drug: Placebo with cognitive behavioural therapy interventionParticipants will be given orally one 25mg MCC inert placebo capsule. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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
- Good command of the English language
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin 5 mg with cognitive behavioural therapy interventionAlso: PsilocybinThis is an oral 5mg psilocybin dose preceding a mental imagery rescripting procedure | Drug | Psilocybin 5mg |
| Placebo with cognitive behavioural therapy interventionThis is an oral placebo comparator preceding a mental imagery rescripting procedure | Drug | Placebo |
Primary outcome
Frequency of mental imagery
Time frame: Up to 3 months
Frequency scores on a 1-10 Likert scale related to self-harm and novel adaptive mental imagery
Vividness of mental imagery
Time frame: Up to 3 months
Vividness scores on a 1-10 Likert scale related to self-harm and novel adaptive mental imagery
Intensity of emotions related to mental imagery
Time frame: Up to 3 months
Emotions' intensity scores on a 1-10 Likert scale related to self-harm and novel adaptive mental imagery
Believability of cognitions related to mental imagery
Time frame: Up to 3 months
Cognitions' believability scores on a 1-10 Likert scale related to self-harm and novel adaptive mental imagery
Schemas
Time frame: Up to 3 months
Scores on Young Schema Questionnaire Short Form (Young et al., 1994)
10 secondary outcomes
Approach Avoidance task
Time frame: Up to 5 months
Probabilistic Reversal Learning Task
Time frame: Up to 5 months
Self-harm Dot Probe Task
Time frame: Up to 5 months
Difficulty in Emotional Regulation
Time frame: Up to 5 months
Self-compassion
Time frame: Up to 5 months
Motivation for Reducing Self-harm
Time frame: Up to 5 months
Mystical Experience
Time frame: Up to 5 months
Challenging Psychedelic Experience
Time frame: Up to 5 months
Emotional Breakthrough
Time frame: Up to 5 months
Attrition
Time frame: Up to 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Background: PubMed 36532196Passie T, Guss J, Krahenmann R. Lower-dose psycholytic therapy - A neglected approach. Front Psychiatry. 2022 Dec 2;13:1020505. doi: 10.3389/fpsyt.2022.1020505. eCollection 2022.
- Background: PubMed 34750350Doss MK, Povazan M, Rosenberg MD, Sepeda ND, Davis AK, Finan PH, Smith GS, Pekar JJ, Barker PB, Griffiths RR, Barrett FS. Psilocybin therapy increases cognitive and neural flexibility in patients with major depressive disorder. Transl Psychiatry. 2021 Nov 8;11(1):574. doi: 10.1038/s41398-021-01706-y.
- Background: PubMed 29923178Erritzoe D, Roseman L, Nour MM, MacLean K, Kaelen M, Nutt DJ, Carhart-Harris RL. Effects of psilocybin therapy on personality structure. Acta Psychiatr Scand. 2018 Nov;138(5):368-378. doi: 10.1111/acps.12904. Epub 2018 Jun 19.
- Background: PubMed 29288686Roseman L, Demetriou L, Wall MB, Nutt DJ, Carhart-Harris RL. Increased amygdala responses to emotional faces after psilocybin for treatment-resistant depression. Neuropharmacology. 2018 Nov;142:263-269. doi: 10.1016/j.neuropharm.2017.12.041. Epub 2017 Dec 27.
- Background: PubMed 36322843Goodwin GM, Aaronson ST, Alvarez O, Arden PC, Baker A, Bennett JC, Bird C, Blom RE, Brennan C, Brusch D, Burke L, Campbell-Coker K, Carhart-Harris R, Cattell J, Daniel A, DeBattista C, Dunlop BW, Eisen K, Feifel D, Forbes M, Haumann HM, Hellerstein DJ, Hoppe AI, Husain MI, Jelen LA, Kamphuis J, Kawasaki J, Kelly JR, Key RE, Kishon R, Knatz Peck S, Knight G, Koolen MHB, Lean M, Licht RW, Maples-Keller JL, Mars J, Marwood L, McElhiney MC, Miller TL, Mirow A, Mistry S, Mletzko-Crowe T, Modlin LN, Nielsen RE, Nielson EM, Offerhaus SR, O'Keane V, Palenicek T, Printz D, Rademaker MC, van Reemst A, Reinholdt F, Repantis D, Rucker J, Rudow S, Ruffell S, Rush AJ, Schoevers RA, Seynaeve M, Shao S, Soares JC, Somers M, Stansfield SC, Sterling D, Strockis A, Tsai J, Visser L, Wahba M, Williams S, Young AH, Ywema P, Zisook S, Malievskaia E. Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. N Engl J Med. 2022 Nov 3;387(18):1637-1648. doi: 10.1056/NEJMoa2206443.
- Background: PubMed 18035331Holmes EA, Arntz A, Smucker MR. Imagery rescripting in cognitive behaviour therapy: images, treatment techniques and outcomes. J Behav Ther Exp Psychiatry. 2007 Dec;38(4):297-305. doi: 10.1016/j.jbtep.2007.10.007. Epub 2007 Oct 26.
- Background: PubMed 28838289Hasking PA, Di Simplicio M, McEvoy PM, Rees CS. Emotional cascade theory and non-suicidal self-injury: the importance of imagery and positive affect. Cogn Emot. 2018 Aug;32(5):941-952. doi: 10.1080/02699931.2017.1368456. Epub 2017 Aug 25.
- Background: PubMed 32057131Di Simplicio M, Appiah-Kusi E, Wilkinson P, Watson P, Meiser-Stedman C, Kavanagh DJ, Holmes EA. Imaginator: A Proof-of-Concept Feasibility Trial of a Brief Imagery-Based Psychological Intervention for Young People Who Self-Harm. Suicide Life Threat Behav. 2020 Jun;50(3):724-740. doi: 10.1111/sltb.12620. Epub 2020 Feb 14.
- Background: PubMed 30688194Ji JL, Kavanagh DJ, Holmes EA, MacLeod C, Di Simplicio M. Mental imagery in psychiatry: conceptual & clinical implications. CNS Spectr. 2019 Feb;24(1):114-126. doi: 10.1017/S1092852918001487. Epub 2019 Jan 28.
- Individual participant dataSharing planned: Yes. All non identifiable outcome measures will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martina Di Simplicio, Dr principal investigator
Imperial College London
David Nutt, Prof principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Psilocybin 5 mg with cognitive behavioural therapy intervention in people with Self Harm, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joanna Vamvakopoulou (+44 (0) 7942292199, imagine@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of mental imagery (time frame: Up to 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06798636, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.