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PsyPal: Psilocybin therapy for the treatment of psychological distress in palliative care patients

Research
Palliative care patients suffer from severe psychological distress that significantly reduces their quality of life. Psilocybin therapy offers an innovative approach that could ease their suffering as they approach the end of life.

Palliative care patients approaching the end-of-life experience severe psychological distress. Amongst many symptoms, this represents a state of intimate and deep suffering that is characterized by depression, (death) anxiety, disconnection, a lack of meaning, and feeling like being a burden to their family. This significantly decreases their quality of life and limits their capability of experiencing a meaningful final stage of life.

This has led us to our research project entitled “PsyPal: Psilocybin Therapy for Psychological Distress in Palliative Care Patients.”

Relevance

Psilocybin therapy to decrease psychological distress in palliative care patients

he aim of PsyPal is to see if psilocybin therapy can significantly decrease psychological distress in four different palliative care patient groups. These include patients that are diagnosed with either chronic obstructive pulmonary disorder (COPD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), and atypical Parkinson’s disease (APD).

There is no cure for any of these conditions. The impact of this terminal diagnosis on the life of patients is profound. Patients are often demoralised in which they experience a significant loss of autonomy and have a lack of meaning in their life. Furthermore, studies estimate that between 34% and 80% of patients suffer from symptoms of depression and anxiety. Not only does this decrease the quality of life of patients, it also significantly affects families, friends, and society at large. Current approaches to treat these symptoms often consist of antidepressants or psychotherapy. Unfortunately, such interventions remain ineffective for most patients. They also require a lot of time and effort to finally take effect. Psilocybin therapy within PsyPal might be the innovative treatment that these patients need.

  • PsyPal aims to treat 100 patients across four clinical sites in Europe. Each clinical site will focus on a specific condition, namely 1) COPD at the University Medical Centre Groningen (UMCG) in the Netherlands, 2) MS at the National Institute of Mental Health in the Czech Republic, 3) ALS at both the University of Copenhagen and the Bispebjerg Hospital in Denmark, and 4) APD at the Champalimaud Foundation in Portugal.

    Within the PsyPal study, patients will receive either two doses of psilocybin (15mg and 25mg) or an active placebo that contains 1mg of psilocybin. In both cases, patients receive the same type of treatment from therapists who are specifically trained for PsyPal. This type of treatment consists of three phases, including 1) preparation, 2) dosing, and 3) integration. In the first phase (preparation), patients receive information about the subjective effects of psilocybin and the therapist aims to build trust with the patient. In the second phase (dosing), patients will receive two doses of psilocybin (or the placebo). Patients are guided by two therapists during the entire session that can last an entire day (6-8 hours). Finally, the third phase (integration) is intended to talk about the patient’s experience with psilocybin. Therapists will help the patient integrate their experience into daily life.

  • PsyPal is a collaborative effort between the University Medical Centre of Groningen and the Swedish company HumanKindLabs. It is the first ever study funded by Horizon Europe that facilitates collaboration between different organisations and further increase the impact of research and innovation. In turn, research projects as PsyPal could address global challenges and lead to the formation of new policies within the European Union.

    PsyPal is a consortium project and involves a collaboration of 19 different European organisations from 9 countries. The following organisations are part of the PsyPal consortium (listed alphabetically): 29k, A+ Science, Bispebjerg Hospital, Champalimaud Foundation, European Association for Palliative Care (EAPC), European Federation of Neurological Associations (EFNA), European Psychiatric Association (EPA), HumanKindLabs, IESE Business School, Lung Alliance Netherlands, Madopa, National Institute of Mental Health in the Czech Republic, Norrsken Mind, OPEN Foundation, University Medical Center Groningen (UMCG), University of Copenhagen, University of Groningen, University of Stockholm, Uppsala University. In addition, the PsyPal consortium will also be actively engaging with PAREA (the Psychedelic Access and Research European Alliance).

Timeline

  1. PsyPal project and HOPE Summit: advancing ethical frameworks in psychedelic therapies

    Posted

    At the Hopkins-Oxford Psychedelic Ethics (HOPE) Summit in Washington, D.C., PAREA represented the PsyPal project, with Founder Tadeusz Hawrot highlighting the project's ethical focus in psilocybin research. PsyPal integrates independent ethics advisors and specific ethics deliverables, ensuring robust oversight in its studies. The summit, gathering top experts, emphasized the need for concrete ethical standards in psychedelic research and development. PsyPal’s dedication to ethical integrity aligns with these priorities, reflecting its pioneering approach. With Johns Hopkins and Oxford’s support, PsyPal promotes a patient-centered care model, combining psychiatry, neuroscience, and spiritual care to set new standards in psychedelic therapy.
    Read more on the HOPE collaboration and the Summit here.

  2. Connecting the Dots: General Assembly meeting

    Posted

    Tijdlijn update: "On June 4th and 5th 2024, partners in the PsyPal General Assembly gathered in scenic Haarlem to mark the project’s first General Assembly meeting. Following a successful kick-off General Assembly meeting in Amsterdam earlier this year, this meeting provided the opportunity for 35 members of the assembly to discuss open questions on the project with a particular focus on the clinical trial. After this meeting, we move forward into the exciting phase of submitting our protocol shortly.

    Read more here: PsyPal Clinical Trial - Connecting the Dots  - Psypal (palliativeprojects.eu)"

  3. PsyPal highlighted on Science Business

    Posted

    Science Business published a comprehensive article on PsyPal's launch: "EU launches landmark €6.5M study on use of psychedelics to treat mental disorders". The article highlights how "the first EU-funded research project into psychedelic drugs is a step on the way to legitimise the field and should lead to more funding". The authors delve into the project aims and the current European regulatory framework around the therapeutic use of psychedelics, discuss funding possibilities, and feature the project's principal investigator, Professor Robert Schoevers.

    Read the full article

  4. Launch of PsyPal in the European Parliament

    Posted

    On April 9, 2024, the launch ceremony of PsyPal took place in the European Parliament in Brussels. The principal investigator of the project, Professor Robert Schoevers, opened the ceremony by presenting an overview of the project, and the project leader, Dr Joost Breeksema, moderated the session. The session was recorded and is openly accessible on youtube.

    Watch the launch of PsyPal

  5. Protocol writing

    Posted

    The first year of PsyPal is completely dedicated to writing the research protocol and developing the therapy manual. The inclusion of the first participants is planned to start from January 1st, 2025 at all four clinical sites, including Groningen, Copenhagen, Prague, and Lisbon.

  6. Launch of PsyPal's website

    Posted

    PsyPal represents an interdisciplinary and collaborative partnership including 19 collaborating European organisations from 9 different countries. The project has its own page under the website of the European Association for Palliative Care, a core partner of large European Union funded studies.

    Keep an eye on our website for updates

This project is part of research group Psychedelic Treatment and Mechanisms

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