Clinical TrialInterpersonal Functioning & Social ConnectednessAyahuascaUnknown status

Ayahuasca Assisted Psychotherapy for Grief

This open-label trial (n=84) will evaluate the efficacy of ayahuasca-assisted constructivist therapy in reducing the severity of grief.

Target Enrollment
84 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Non-randomised, parallel-group trial (n=84) comparing ayahuasca-assisted constructivist therapy, constructivist psychotherapy alone, and no treatment with assessments at baseline, posttest and 3-month follow-up to prevent prolonged or persistent complex bereavement.

Experimental arm receives 9 online psychotherapeutic sessions with one preparation session, two integration sessions and two oral ayahuasca administrations (0.75 mg/kg DMT) after sessions 3 and 6; control arms receive psychotherapy alone or no treatment with option for ayahuasca after follow-up.

Study Protocol

Preparation

1 sessions

Dosing

2 sessions

Integration

2 sessions

Therapeutic Protocol

other

Study Arms & Interventions

Ayahuasca + therapy

experimental

Two ayahuasca administrations (0.75 mg/kg DMT) combined with 9-session constructivist psychotherapy; includes one preparation and two integration sessions.

Interventions

  • Ayahuasca0.75 mg/kg
    via Oral• two sessions• 2 doses total

    Administered after sessions 3 and 6; psychotherapy: 9 online sessions with 1 prep and 2 integration sessions.

Constructivist Psychotherapy

active comparator

9 online constructivist psychotherapy sessions; option to receive ayahuasca after follow-up if severity remains high.

Interventions

  • Compound

    Constructivist Psychotherapy delivered over 9 online sessions; option for two ayahuasca administrations after 3-month follow-up if indicated.

No treatment

waitlist

No treatment during the 9-week control period; option to receive ayahuasca after follow-up if severity high.

Interventions

  • Compound

    No treatment during control period; optional ayahuasca after 3-month follow-up if indicated.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Experienced the loss of a first-degree relative not more than 12 months prior to enrollment as indicated by self-report.
  • Scores up to 40 in the Texas Revised Inventory of Grief (TRIG).

Exclusion Criteria

  • Exclusion Criteria:
  • Pregnant or breastfeeding women.
  • Hypertension (systolic blood pressure above 140 mm, diastolic above 90 mm and heart rate above 100 bpm).
  • History of psychotic disorder (Axis I-II of the DSM-V).
  • Substance use disorder (except nicotine).
  • Alcohol consumption greater than 40 g/day.
  • Receiving psychological or self-help therapy during the study on a regular basis.
  • Receiving regular pharmacological therapy for complicated grief during the study.
  • Regular intake of any type of medication in the month preceding the study.
  • Treatment with single doses of symptomatic medication during the study may be accepted (as long as it can be assumed that the ingested drug has been completely eliminated on the days of the ayahuasca administrations).

Study Details

Locations

Institut de Recerca Holistica de Montserat (Irehom) — Barcelona, Spain

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