The role of self-compassion and the therapeutic relationship in psilocybin therapy for treatment resistant depression
Abstract
Treatment resistant depression leads to high rates of disability and mortality and a very high socioeconomic burden 18, being the second leading cause of disability worldwide by 2020 14. The STAR-D study, a large trial involving four steps of treatment, found that 66% of patients eventually reached remission but 33% never did 20. Those who do not respond to multiple treatments have a poor prognosis that contributes to a disproportionate amount of socioeconomic burden, which justifies a research focus on novel therapeutic interventions 5 such as psilocybin with psychological support. Recent open label and randomised control trial results investigating psilocybin with psychological support for depressive symptoms are looking promising with a very good safety profile. However, high-dose psilocybin is not a simple pharmacological agent that should be dispensed to the individual from a pharmacy. Rather, there is a basic assumption that the therapeutic effect of psilocybin most likely depends on a complex interplay between ‘set’ (the intentions and psyche of the subject) and ‘setting’ factors (context in which it is taken) and the subjective experience of the six hour idiosyncratic psychedelic ‘trip’ with a potential for negative sequelae if the subject does not feel psychologically and physically safe. Preliminary evidence shows that therapeutic relationship between patient and psychedelic guide is associated with subjective dosing effects related to improvements in depression and this study will aim to further this evidence. Self-compassion as conceptualised by Kristen Neff is known to play a buffering role in depression however the direction of relationship between self-compassion and depression is not always clear. Previous studies have shown that dosing effects of psilocybin manifest compassion type experiences and it has been reported by previous participants of psilocybin trials that these are important for their recovery. No clinical study has quantitatively investigated whether psilocybin increases self-compassion and whether this mediates psilocybin’s effect in treatment resistant depression. Also no study has explored the relationship between therapeutic relationship, compassion experiences and changes in self-compassion with improvements in depression in psilocybin therapy. My research questions below will form part of the tertiary outcomes of the Psilocybin in Depression Resistant to standard treatment (PsiDer) trial led by Dr James Rucker and funded by the National Institute for Health Research to investigate the safety, feasibility and efficacy of psilocybin in treatment resistant depression (TRD), using the gold standard design of a randomised placebo-controlled trial. The study has recruited 60 participants with current depression unresponsive to usual treatments. The main outcome of the study is to evaluate the feasibility of a randomised, controlled trial design in which a single dose of oral psilocybin 25mg vs. placebo will be given to adult participants with treatment resistant major depressive disorder (TRD), under psychologically supportive conditions, with 6 weeks of follow up. At 6 weeks follow up all participants will be offered an open label extension consisting of a single dose of 25mg psilocybin, delivered under identical conditions, with a further 12 weeks of follow up.
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