Ayahuasca Assisted Psychotherapy for Grief

NCT06150859 | Unknown Phase 2

• 1 other identifier: PI-19-118
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effectiveness of an ayahuasca-assisted constructivist therapy with constructivist therapy and no treatment to decrease the severity of grief. A secondary purpose is to assess the effectiveness to prevent Persistent Complex Bereavement Disorder and Prolonged Grief Disorder, and to assess potential changes in avoidance, meaning-making and self-clarity. Subjective effects and Acceptance promoting effects of psychedelic drug are assessed after ayahuasca administration. A non-randomized controlled trial is proposed with three arms involving an experimental group (ayahuasca in concert with psychotherapy) and two control groups (psychotherapy and no treatment) with pretest, posttest and 3 months follow-up.

Conditions

Bereavement

Keywords

Bereavement; Ayahuasca; Psychotherapy; Prevention

Outcome Measures

Primary Outcomes (1)

• Change in the severity of grief symptoms

  Change in grief severity is measured by the present scale of Texas- Revised Grief Inventory (TRIG), a measure of normal grief symptoms. For the TRIG the minimum units are 0 and Maximum units on the total scale are 65. The higher the number on the TRIG, the more severe the symptoms.

  Time Frame: Baseline to End of Intervention, up to 3 months

Secondary Outcomes (1)

• Prevalence of Persisten Complex Bereavement (PCBD) and prolonged Grief Symptoms (PGD).

  Baseline to End of Intervention, up to 3 months

Other Outcomes (7)

• Individual's quality of life

  Baseline to End of Intervention, up to 3 months

• Posttraumatic Growth

  Baseline to End of Intervention, up to 3 months

• Avoidance

  Measured using the Acceptance and Action Questionnaire (AAQ-II). The AAQ-II has 7 items rated on a 7-point Likert scale ranging from 1 ("never true") to 7 ("always true") to assess indirectly acceptance. Higher scores indicate a higher avoidance.

Study Arms (3)

Experimental: Ayahuasca-assisted constructivist therapy.

EXPERIMENTAL

Constructivist psychotherapy will be delivered over 9 online psychotherapeutic sessions interconnected in 3 modules to process trauma, restore attachment security and reconstruct the self. One preparation session and two integration sessions after two ayahuasca administrations are included to the experimental group.

Drug: Ayahausca-Assisted psychotherapy

Constructivist Psychotherapy

ACTIVE COMPARATOR

Constructivist Psychotherapy will be delivered over 9 online psychotherapeutic sessions interconnected in 3 modules to process trauma, restore attachment security and reconstruct the self. Once the follow-up period is over (3 months), participants have the option of receiving 2 administrations of ayahuasca if the severity of grief is high.

Behavioral: Constructivist Psychotherapy

No treatment

OTHER

Participants received no treatment during the 9-week Control Period. Once the follow-up period is over (3 months), participants have the option of receiving 2 administrations of ayahuasca if the severity of grief is high.

Other: No treatment

Interventions

Ayahausca-Assisted psychotherapy DRUG

Drug: Two ayahuasca administrations (0.75 mg/kg DMT), after 3rd and 6th therapeutic session. Ayahuasca is a psychoactive mixture of plants which contains DMT as an active principle. Constructivist Psychotherapy will be delivered over 9 online psychotherapeutic sessions.

Also known as: Ayahausca-assisted grief therapy

Experimental: Ayahuasca-assisted constructivist therapy.

Constructivist Psychotherapy BEHAVIORAL

Constructivist Psychotherapy will be delivered over 9 online psychotherapeutic sessions

Constructivist Psychotherapy

No treatment OTHER

No treatment during the control period

No treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Beckley Med Foundation: lead

Study Sites (1)

Institut de Recerca Holistica de Montserat (Irehom)

Barcelona, 08253, Spain

Location

Related Publications (1)

• Sabucedo P, Andion O, Neimeyer RA, Soto-Angona O, Javkin J, Haro JM, Farre M, Gonzalez D. Ayahuasca-assisted meaning reconstruction therapy for grief: a non-randomized clinical trial protocol. Front Psychiatry. 2025 Jan 7;15:1484736. doi: 10.3389/fpsyt.2024.1484736. eCollection 2024.

  PMID: 39839135 DERIVED

Study Officials

• Magi Farré

  Hospital German Trials I Pujol

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 29, 2023
• Study Start: October 15, 2021
• Primary Completion: April 15, 2024
• Study Completion: June 15, 2024
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

ES (1)