Psychedelic research faces unique methodological challenges beyond those typical of psychotherapy and pharmacology trials. The pronounced subjective effects of high-dose psychedelics make it difficult to mask participants to their treatment condition. Positive media coverage inflates participants' expectations for benefit, and unmasking combined with expectations can produce large placebo and nocebo effects. Recommendations to improve masking and reduce expectancy bias include careful study development, participant recruitment and selection, incomplete disclosure of study design, choice of active placebo, and measurement of expectations and masking efficacy. Incorporating these design elements aims to reduce bias and improve the ability to discern treatment-specific effects.
Clinical trials of psychedelic therapy face unique methodological challenges that threaten the interpretability of results. The intense subjective effects of high-dose psychedelics make it difficult to mask participants to their treatment condition, and widespread positive media coverage inflates participants' expectations for benefit. Participant unmasking and treatment expectations can interact, making psychedelic therapy highly susceptible to large placebo and nocebo effects. Recommendations to improve rigor include careful study development, participant recruitment and selection, incomplete disclosure of the study design, choice of active placebo condition, and measurement of participant expectations and masking efficacy. Incorporating these design elements is intended to reduce bias and increase the ability to discern treatment-specific effects.
Chronic low back pain is common and disabling, and self-management strategies that can be done at home are needed. Breathing practices may help because breathing is linked to stress, emotion, and pain. This pilot study will test the feasibility and acceptability of a 5-day conscious connected breathing with breath retention intervention compared to a deep breathing sham control in 24 adults with chronic low back pain. Both interventions are delivered via standardized audio recordings and described as Breathing and Attention Training to reduce expectancy effects. Feasibility will be assessed through recruitment, adherence, retention, and completion rates, and acceptability through participant satisfaction and helpfulness ratings.
A single session of Guided Respiration Mindfulness Therapy (GRMT), an integrative breathwork intervention involving one hour of conscious connected breathing with somatically focused mindfulness and relaxation, was highly acceptable and satisfying to adults with chronic pain. Among 11 enrolled participants, 10 completed the session; all recommended the intervention to others. Large, clinically meaningful improvements in pain intensity and pain interference occurred from baseline to 2-week and 6-week follow-ups, with mean differences of -2.9 and -3.5 respectively. The findings demonstrate proof of concept and warrant further research.