Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06150859
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-12-11
First Post:
2023-11-21
Brief Title:
Ayahuasca Assisted Psychotherapy for Grief
Sponsor:
Beckley Med Foundation
Organization:
Beckley Med Foundation
Study Overview
Official Title:
Efficacy of Ayahuasca in Concert With Psychotherapy to Decrease the Severity of Grief
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSICODUELAYA
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
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 041-045 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None