This open-label trial (n=84) will evaluate the efficacy of ayahuasca-assisted constructivist therapy in reducing the severity of grief.
Conducted by the Beckley Med Foundation in Barcelona, Spain, the study aims to compare the effectiveness of ayahuasca-assisted constructivist therapy with constructivist therapy and no treatment in reducing grief severity.
The primary outcome measure is the change in grief symptoms measured by the Texas Revised Inventory of Grief (TRIG). Secondary outcomes include the prevalence of Persistent Complex Bereavement Disorder (PCBD) and prolonged grief symptoms, quality of life, posttraumatic growth, avoidance, meaning-making, and consistency of self-beliefs.
Participants, aged 18 to 65, who have experienced the loss of a first-degree relative within the past 12 months, will be recruited. The trial involves three arms: an experimental group receiving ayahuasca-assisted constructivist therapy, a control group receiving constructivist psychotherapy, and a no-treatment control group. The study will include pretest, posttest, and 3-month follow-up assessments. The trial commenced on October 15, 2021, with an estimated primary completion date of April 15, 2024, and a study completion date of June 15, 2024.
Trial Details
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.NCT Number NCT06150859
Sponsors & Collaborators
Fundación Beckley MedFundación Beckley Med is a non-profit organization, dedicated to the development of innovative mental health research and treatments, the study of consciousness and the training of specialists in psychedelic-assisted therapy.