Psilocybin-Assisted Therapy for Intergenerational Trauma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRachel Yehuda
About this trial
This is an open-label psilocybin-assisted therapy study that will examine the safety and tolerability of psilocybin-assisted therapy in the offspring of genocide survivors with mood and anxiety disorders.
The study will also investigate the efficacy of psilocybin-assisted therapy in reducing symptoms such as depression, anxiety and stress, as well as changes to the psychological effects of parental exposure to genocide, and changes to psychological resilience.
Eligibility criteria
Qualifiers
Age at least 18 years old at time of signing the informed consent.
Biological child of at least one parent who directly survived/escaped a genocide.
Evidence of clinically significant intergenerational trauma-related symptoms, as determined by the modified Parental PTSD Questionnaire (mPPQ).
Meet diagnostic criteria for a depressive, anxiety, trauma-, or stressor-related disorder on the Structured Clinical Interview for DSM-5 (SCID-5).
Disqualifiers
Individual was directly exposed to the genocide.
Current or recent illicit drug or prescription drug substance use disorder (excluding cannabis and tobacco use disorders), as determined by DSM-5 criteria and clinical assessment.
Current or recent alcohol or cannabis use disorder that, in the opinion of the investigator, may interfere with safe participation or study outcomes.
Current psychiatric hospitalization or psychiatric hospitalization within the last 6 months.
Trial design
Treatments tested in this trial
- Psilocybin
- Integration sessions
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Rachel Yehuda
Lead sponsor
Icahn School of Medicine at Mount Sinai
Sponsor institution
Source ClinicalTrials.gov