NCT06150859

Ayahuasca Assisted Psychotherapy for Grief

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Beckley Med Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Bereavement

Interventions

Type	Name	Description
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.
BEHAVIORAL	Constructivist Psychotherapy	Constructivist Psychotherapy will be delivered over 9 online psychotherapeutic sessions
OTHER	No treatment	No treatment during the control period

Timeline

• Start date: 2021-10-15
• Primary completion: 2024-04-15
• Completion: 2024-06-15
• First posted: 2023-11-29
• Last updated: 2023-12-11

Locations

1 site across 1 country: Spain