Ayahuasca Assisted Psychotherapy for Grief (PSICODUELAYA)

Efficacy of Ayahuasca in Concert With Psychotherapy to Decrease the Severity of Grief

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Bereavement
• Intervention / Treatment: Drug: Ayahausca-Assisted psychotherapy; Behavioral: Constructivist Psychotherapy; Other: No treatment

Detailed Description

Grief is a deep and intense sorrow caused by the loss of someone loved. Although every person could benefit from support, only a substantial minority of bereaved people experience severe, persistent and disabling grief (PCBD), requiring treatment one year after the death of a loved one. However, pharmacotherapy alone has not proven to be effective, and while psychological interventions for prolonged grief disorder may be efficacious, the clinical effectiveness is small (Hedges' g: 0.41-0.45). As far as we know, no bereavement prevention program has proven to be effective, and early interventions are discouraged. Thus, there are no effective resources for supporting the bereaved during the months following the death of a loved one, a need which peaks during the months following the death, when grief is most intense and the bereaved lives are at their highest level of risk.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08253
    • Institut de Recerca Holistica de Montserat (Irehom)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Constructivist Psychotherapy; 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; Constructivist Psychotherapy will be delivered over 9 online psychotherapeutic sessions
Other: No treatment; 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; No treatment during the control period
Experimental: Experimental: Ayahuasca-assisted constructivist therapy.; 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; 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.; Other Names: Ayahausca-assisted grief therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Persisten Complex Bereavement (PCBD) and prolonged Grief Symptoms (PGD).	Measured using the Traumatic Grief Inventory self-report version (TGI-SR). The TGI-SR is a 18-item self-report measure to assess symptoms of Persistent Complex Bereavement Disorder (PCBD) included in Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 and Prolonged Grief Disorder (PGD). A score of ≥61 optimally classified participants as meeting criteria for PCBD-caseness and a score of ≥59 classified participants as meeting criteria for PGD-caseness.	Baseline to End of Intervention, up to 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Posttraumatic Growth	Measured using the Posttraumatic Growth Inventory Short-Form (PSI-SF). The PSI-SF has 10 items rated on 6-point Likert scale ranging from 1 ("completely disagree") to 6 ("completely agree"). This questionnaire includes 4 sub scales: New Possibilities, Personal Strength, Spiritual Change, and Appreciation of Life. Higher scores indicate a higher posttraumatic growth.	Baseline to End of Intervention, up to 3 months
Avoidance	Baseline to End of Intervention, up to 3 months	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.
Meaning-made	Measured using the Stressful Life Experiences Scale (ISLES-SF). The ISLES-SF has 6 items rated on a 5-point Likert scale, ranging from 1 ("completely agree") to 5 ("completely disagree"). The questionnaire includes two subscales: Comprehensibility and Footing in the World. Higher scores indicate more adaptive meaning made of a loss. Baseline to End of Intervention, up to 3 months	Baseline to End of Intervention, up to 3 months
Consistency of self beliefs	Measured using the Self-concept Clarity Scale (SCS). The SCS has 12 items rated on a 7-point Likert scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"). Higher scores reflect greater self-concept clarity.	Baseline to End of Intervention, up to 3 months
Subjective effects of ayahuasca.	Measured using the Five Dimensional Altered States of Consciousness" (5D-ASC). The 5D-ASC has items rated on a 100-point Likert scale ranging from 0 ("No, no more than usually) to 100 ("Yes, much more than usually"). The questionnaire includes three subscales: Visionary Restructuralization, Oceanic Boundlessness and Anxious Ego-Dissolution	3 days after each ayahuasca administration
Acceptance promoting effects of psychedelic drug	Measured using the Acceptance/Avoidance-Promoting Experiences Questionnaire (APEQ). The APEC has 32 items rated on a 0 ("No, not at all") and 100 ("Yes, extremely or absolutely"). The questionnaire includes two main scales, acceptance-related experience (ACE) and avoidance-related experience (AVE).	3 days after each ayahuasca administration
Individual's quality of life	Measured using the World Health Organization Quality of Life-Bref (WHO-qol-BREF). The WHO-qol-BREF has 26 items rated on 4 answer options. Only subscales on physical health, pshychological health and social relationships were included in this study. Higher scores indicate a better subjective QOL.	Baseline to End of Intervention, up to 3 months

Collaborators and Investigators

• Sponsor: Beckley Med Foundation
• Investigators: Study Director: Magi Farré, Hospital German Trials I Pujol

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Estimated): April 15, 2024
• Study Completion (Estimated): June 15, 2024

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Prevention; Psychotherapy; Bereavement; Ayahuasca
• Other Study ID Numbers: PI-19-118

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No