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 people had significantly longer ‘relative telomere length’ (RTL) compared to those practising a mindfulness-based meditation and a control group. Shorter telomeres have been linked to chronic stress in previous research studies, the research shows that specific lifestyle behaviours that can mitigate the effects of stress might be associated with longer telomere lengths and therefore greater life expectancy. A key factor may be the emotional response elicited during meditation and associated mind-based therapies.
With the body of research expanding year upon year, it is critical that the clinical research industry adopt a synergistic approach to evidence-based enquiry to promote the best response to treatment possible. It is our duty as care providers and health-researchers to promote and incorporate all necessary elements for positive health and well-being throughout the clinical trial process.
By translating this research into clinical practise, clinical research and beyond, we anticipate our ‘Caritas Cohesion’ patient-centred approached can:
· Improve focus on patient safety and compassionate care
· Optimise patient recruitment & retention
· Enhance response to treatment outcomes
· Provide empirical evidence-based research needed to revolutionise patient-centred trials
At Caritas, we are well positioned with a wealth of experience bridging both pharmaceutical and mind/body-therapies and are excited to discuss options for incorporating Caritas Cohesion synergy with our clients in the coming weeks. We are dedicated to providing this patient-centred, novel approach tailoured specifically for each clinical research protocol to ultimately enhance the lives of the patients taking part in our trials to their fullest potential.
Written by Heather Thomson for Caritas Neuro Solutions
See https://caritasneuro.com/caritas-cohesion/ for further details.