At Caritas Neuro Solutions, our team have experience spanning over the last two decades working to bring novel treatments to market in a cross-section of therapeutic areas from Alzheimer’s to Oncology. However, none of the trials until now have invited clinical trial participants to work on their ‘mindset’ to encourage additional potential benefits in participating and enhance response to treatment. In line with our client’s aims of developing novel compounds and improved formats for neurological conditions and with cutting edge neuroscience research, we are excited to apply our ‘Caritas Cohesion’ model, the next evolution in patient-centred trials.
We offer support for clinical trial participants to utilise mind-based therapeutics throughout the clinical trial process, endorsing clinically cohesive care. Our integrative model combines skills and expertise in optimised mind-based therapeutic regimes allowing application to expedite and enhance pharmaceutical medicine development.
A huge body of research now exists from leading academic institutions including Stanford and Harvard in the USA to Max Planck institute in Germany that determine mind-based practices such as CBT (cognitive behavioural therapy); mindfulness; meditation and breath-work promote an improved quality of life and well-being. Caritas see the vital role we can play to incorporate this understanding within research trials, particularly within neurological conditions.
The pharmaceutical industry has been relatively slow to fully tap into these well documented benefits by merging research into new pharmaceutical products with methods that have been perhaps traditionally labelled holistic and kept at arm’s length out-with the commercially funded clinical research industry. We are working collaboratively with our partners and stake-holders to revolutionise out-dated approaches through our comprehensive integrative model.
Research at Harvard has shown that yoga and meditation reduce perceived stress and anxiety, appearing to modulate stress response systems, in turn, decreasing physiological arousal - reducing heart rate, lowering blood pressure, and easing respiration. There is also evidence that yoga practices help increase heart rate variability, an indicator of the body's optimised ability to respond to stress more flexibly and arguably a necessary physiological state for recovery from ill-health to occur.
Previous research shows that utilising an 8 week training of a compassion-based meditation ‘diet’ is associated with reduced perception of pain, increased social closeness, positive emotions and decreased suppression of emotions and decreased release of stress hormones in patients suffering from chronic pain. The use of compassion-based meditations is likely a useful adjunctive treatment for reducing pain severity and improving over-all response-to-treatment across a multitude of patient populations.
Pioneering synergistic research at the University of Zurich, examined the effects of combining meditation with psilocybin in depression and anxiety disorders in 2019. The meditation practice was shown to increase positive effects of psilocybin continuing to the 4-month follow up visit. Benefits included changes in psychosocial functioning, better self-acceptance and more empathy when compared to the placebo group that received psilocybin only.
There also exists a huge potential to explore into the benefit of mind-based practices expanding wider than neurological conditions into other therapeutic areas.
A data review in May 2019 published in Cureus examining mindfulness-based practises in various aspects of cancer management, concluded that most evidence of the benefit is to reduce toxicity and stress, which are known precursors of disease and likely potential factors in recurrence of disease. There is a need for more prospective trials exploring it’s use in reducing cancer incidence and preventing recurrence.
In 2014 researchers using ‘relatively short telomere length’ as a marker of accelerated ageing investigated how psychosocial interventions over a period of 8 weeks providing stress reduction and emotional support impacted telomere length maintenance in breast cancer survivors who had completed all medical treatments at least 3 months previously. The study concluded that mindfulness‐based cancer recovery and supportive‐expressive therapy maintain telomere length (and therefore life expectancy) relative to controls in distressed breast cancer survivors
Interestingly, a further study in 2019 with healthy volunteers, showed that practitioners of the Loving-Kindness Meditation (LKM), a practice derived from the Buddhist tradition utilising a focus on unselfish kindness and warmth towards all