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Psilocybin-Assisted Therapy for Intergenerational Trauma

ConditionsPsychological StressDepressionAnxiety
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Psilocybin

    Drug

    Psilocybin 25mg, capsules taken orally under the supervision of two trained study therapists

  • Integration sessions

    Behavioral

    weekly integration sessions (therapy) for 6 weeks

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Psilocybin-Assisted TherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Columbia-Suicide Severity Rating Scale (C-SSRS)

Suicide risk as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Full Scale: 0 - 6. Higher scores indicate increased risk of suicide.

Time frame
up to 23 weeks
2

Brief Psychiatric Rating Scale (BPRS-6)

Brief Psychiatric Rating Scale (BPRS-6) - Full Scale: 0 - 36. Higher scores indicate the number and severity of psychiatric symptoms.

Time frame
up to 23 weeks

Secondary outcomes

1

Change in Depression, Anxiety, and Stress Symptoms Scale (DASS-21)

Change in Depression, Anxiety, and Stress Symptoms Scale (DASS-21) score. Stress scale - Subscale: 0 - 42 Anxiety scale - Subscale: 0 - 42 Depression scale - Subscale: 0 - 42 Full scale: 0 - 126 Higher scores indicate higher severity of symptomology.

Time frame
Baseline (V0), Weeks Week 4-10 (V7), Week 6-15 (V11), Week 23(V12)
2

Change in Parental PTSD Questionnaire (PPQ)

Change in Parental PTSD Questionnaire (PPQ) score. Full Scale: 11 - 55 Higher scores indicate more negatively affected by perception of parents' trauma

Time frame
Baseline (V0) and Week 23 (V12)
3

Change in Resilience Scale for Adults (RSA)

Change in Resilience Scale for Adults (RSA) score. Full Scale: 33- 231 Higher scores indicate higher resilience

Time frame
Baseline (V0) and at Week 23 (V12)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rachel Yehuda

Lead sponsor

Icahn School of Medicine at Mount Sinai

Sponsor institution

Source ClinicalTrials.gov
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