Clinical TrialMajor Depressive Disorder (MDD)PsilocybinCompleted

Low-Income Group Psilocybin Assisted Therapy for Depression (LIGPATD)

Open-label, single-group feasibility study (n=20) evaluating group psilocybin-assisted therapy (two psilocybin sessions) for low-income adults with major depression in Oregon.

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Target Enrollment
20 participants
Study Type
Phase NA interventional
Design
Non-randomized

Detailed Description

This feasibility study tests group psilocybin-assisted therapy delivered under Oregon Psilocybin Services to adults with major depression who have incomes at or below 200% of the federal poverty level.

Participants are placed into cohorts of five to six; treatment includes two 90-minute group preparation sessions, two psilocybin dosing sessions guided by two licensed facilitators, and two 90-minute group integration sessions, with a three-month follow-up.

Feasibility outcomes are recruitment, retention, acceptability and safety; other measures include ACE, CEQ, Hamilton Depression Inventory, PROMIS-29, 11-ASC, and structured interviews.

Study Protocol

Preparation

2 sessions
90 min each

Dosing

2 sessions

Integration

2 sessions
90 min each

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin group

experimental

Uncontrolled single-group cohort model (cohorts of 5–6) with two preparation sessions, two psilocybin dosing sessions, and two integration sessions.

Interventions

  • Psilocybin
    via Oral• two sessions• 2 doses total

    Psilocybin administered per Oregon Psilocybin Services rules; sessions guided by two licensed facilitators; no fixed dose specified in registry fragment.

Participants

Ages
21 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Oregon resident (due to telehealth/licenses)
  • Age 21 or older
  • Income at or below 200% of the Federal Poverty Line
  • DSM-5 diagnosis of Major Depressive Disorder
  • Current engagement with psychotherapy (≥6 sessions in prior 6 months and intent to continue at least once every 2 weeks during study; release of information required)
  • At least six months of stable housing history
  • Able to attend all study events
  • Able to read and speak fluent English

Exclusion Criteria

  • Exclusion Criteria:
  • Personal or family history of schizophrenia, psychosis, mania, or hypomania
  • Current prescription for lithium
  • Active suicidal ideation or history of suicide attempts (passive ideation permitted)
  • Uncontrolled hypertension
  • Any form of personality disorder

Study Protocol, Arms & Participants

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Study Details

Locations

National University of Natural Medicine — Portland, Oregon, United States

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