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Expectations and Motivations for Participation in Clinical Trials Utilizing Psychedelics for Treatment-Resistant
Christopher Poppe1,2, Liisa Lyck1, Laura Bechtold1,2
1Department of Psychiatry and Neurosciences, Campus Charité Mitte, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Participant expectations in psychedelic trials for treatment-resistant depression are complex and evolve. Understanding these motivations and expectations is crucial for interpreting clinical outcomes and improving trial design.
Area of Science:
- Psychiatry
- Clinical Psychology
- Neuroscience
Background:
- Participant expectations significantly influence clinical trial outcomes, contributing to placebo effects.
- The subjective and multidimensional nature of expectations, particularly in treatment-resistant depression (TRD), requires further exploration.
- Existing quantitative tools may not fully capture the nuances of participant expectations in psychedelic research.
Purpose of the Study:
- To explore the motivations and expectations of individuals participating in clinical trials involving psychedelics for TRD.
- To understand the factors influencing participants' decisions to join these trials.
- To investigate how expectations are formed and potentially change throughout the trial process.
Main Methods:
- Conducted 17 semi-structured interviews with individuals before screening for TRD trials using 5-MeO-DMT or psilocybin.
- Performed two follow-up interviews with participants post-trial.
- Analyzed interview data thematically to identify key themes and subthemes related to motivations and expectations.
Main Results:
- Identified two primary themes: motivations (hope, demoralization, prior psychedelic experience, social factors) and expectations (symptom reduction, perceived mechanisms, setting, retrospective views).
- Many participants viewed trial involvement as a final option due to chronic illness and treatment failure.
- Retrospective accounts indicated that initial expectations could be reinterpreted as stronger post-participation.
Conclusions:
- Participant expectations in psychedelic trials are intricate and dynamic, evolving over the course of the study.
- There is a critical need to systematically address and measure expectancy in clinical trial design, informed consent procedures, and the interpretation of results.
- These insights are particularly relevant for studies involving treatment-resistant populations and psychedelic interventions.
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