Ayahuasca Assisted Psychotherapy for Grief

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Bereavement

Intervention / Treatment
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* Drug: Ayahausca-Assisted psychotherapy
* Behavioral: Constructivist Psychotherapy
* Other: No treatment


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bereavement, Ayahuasca, Psychotherapy, Prevention