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Psychedelic-assisted therapy shows promise for treating various mental health conditions; however, its reliance on intensive psychological preparation limits its broader application. Digital health interventions have the potential to address this limitation by providing structured, accessible and scalable preparation solutions. This randomised controlled feasibility trial aims to evaluate the feasibility and preliminary efficacy of the Digital Intervention for Psychedelic Preparation (DIPP), a 21-day mobile-accessible programme designed to prepare individuals for psychedelic experiences.
The study will recruit 40 non-treatment-seeking adults without a clinical diagnosis, randomly assigning them to one of two conditions: (1) DIPP-MEDITATE, which combines daily guided meditation with background music or (2) DIPP-MUSIC, which provides the same background music without guided meditation. Both groups will complete the 21-day digital intervention remotely. Following the intervention, participants will attend an in-person supervised psilocybin session, receiving a standardised 25 mg dose. Primary outcomes focus on feasibility metrics including recruitment efficiency, participant retention and adherence to the intervention protocol. Secondary outcomes assess subjective feasibility, acceptability and preliminary efficacy, specifically evaluating psychedelic preparedness, the quality of the psychedelic experience and changes in wellbeing, with follow-up assessments at 2 weeks, and at 3, 6 and 9 months post-session. Exploratory measures include neuroimaging, physiological, cognitive and psychological assessments, as well as voice note experience sampling through a chatbot (referred to as ‘DIPP-bot’) to monitor inner speech, thought and emotional states during the intervention and follow-up periods.
Approved by UCL Research Ethics Committee (ID: 19113/003), this study follows the Declaration of Helsinki. Results will be published in peer-reviewed journals and presented at conferences. Confidentiality will be maintained throughout.
by Krystyna Piotrowska-Weryszko, Agnieszka Kubik-Komar, Elżbieta Weryszko-Chmielewska, Agata Konarska, Aneta Sulborska-Różycka
Grass pollen grains cause allergic reactions in a large portion of the global population. Aerobiological monitoring provides a valuable method for assessing plant responses to climate change. Wind-pollinated plants exhibit varying responses to climate shifts, and this study aimed to analyze long-term trends in Poaceae pollen concentration in Lublin (Poland) from 2001 to 2022. Pollen seasons were analyzed using the volumetric method. The following parameters were assessed for each season: onset, end, duration, peak value, date of peak, number of high-pollen days, and annual pollen sum. Meteorological data were collected for the same period. Statistical analysis was performed using Spearman’s rank correlation to examine relationships between pollen season parameters and meteorological factors, and multivariate regression models were developed to explore the influence of specific climate variables on pollen season dynamics. Additionally, principal component analysis (PCA) was applied for visual comparisons of grass seasons. The analysis revealed a significant decline in the annual pollen sum, the July pollen sum, and the number of high pollen days, with the most substantial changes occurring in July. The decrease in the annual pollen sum was significantly associated with lower humidity in March and May and higher temperatures in June. Peak pollen values were negatively correlated with increased sunshine in March and April and positively correlated with humidity in March and May, while humidity levels strongly influenced the number of high-pollen days. The intensity of the grass pollen season notably weakened after 2011, in alignment with broader trends observed across Europe, attributed to climate change. These findings highlight the substantial influence of climatic variables on the grass pollen season, with implications for individuals with respiratory allergies. The results also underscore the broader public health and ecological impacts of climate change, suggesting the need for continued monitoring and adaptive measures.Salvage prostatic bed radiotherapy (PBRT) is a standard in case of biochemical recurrence following radical prostatectomy (RP) for prostate cancer (PC). The management of isolated prostatic bed recurrence following RP and PBRT is debated. Reirradiation within stereotactic body radiotherapy (SBRT) guided by metabolic imaging could be a relevant option in this case. In parallel, metformin, an economically viable and well-tolerated oral antidiabetic agent, has demonstrated its radiosensitising properties. This phase I/II clinical trial aims to (i) determine the optimal dose for SBRT reirradiation, (ii) conduct safety assessments and (iii) evaluate the efficacy of the metformin and SBRT combination.
We conducted a prospective, non-randomised, open-label, multicentre, dose escalation, phase I/II study involving a minimum of 44 patients. Eligible patients must have biochemical recurrence (Prostate Specific Antigen (PSA)>0.2 ng/mL and confirmed ascending trend in at least two successive assays), occurring at least 2 years after PBRT and prior RP for PC (including low, intermediate and high risk with a single risk factor) and no Common Terminology Criteria for Adverse Events (CTCAE) grade>=2 toxicity following PBRT. The recurrence should be visible on MRI and/or Positron Emission Tomography (PET) Choline and/or PET PSMA, without evidence of pelvic lymph node recurrence or metastatic disease. The primary objective of phase I is to determine the optimal SBRT dose (5x6, 6x6, or 5x5 Gy) based on dose-limiting toxicity (DLT). The dose will be chosen using a time-to-event continual reassessment method based on DLT, defined as CTCAE grade ≥3 gastrointestinal or genitourinary toxicity, or any other grade 4 adverse event. The primary outcome of the phase II is to estimate the efficacy of SBRT in combination with metformin in terms of biological relapse-free survival (bRFS) rate at 3 years. Secondary outcomes include 5-year bRFS rate, early/late genitourinary and gastrointestinal toxicities, quality of life, biochemical response rate, clinical progression-free survival and overall survival (OS).
Ethical approval has been obtained from the Ethics committee "SUD EST III Bron" Ref.CPP 2020-042B (20.05.07.72735) and the National Agency for the Safety of Medicines (ANSM) Ref. ANSM MEDAECNAT-2020-05-00009. The ethics approval obtained covers all the sites that will take part in this study. The study’s findings will be disseminated through publications and conference presentations.
NCT04536805, Registration Date: 2020-08-17
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