Efficacy of Ayahuasca in Concert With Psychotherapy to Decrease the Severity of Grief
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in the severity of grief symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Ayahausca-Assisted psychotherapy (Drug)
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.
干预措施: Constructivist Psychotherapy (Behavioral)
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.
干预措施: No treatment (Other)
结局指标
主要结局
Change in the severity of grief symptoms
时间窗: Time Frame: Baseline to End of Intervention, up to 3 months
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.
次要结局
- Prevalence of Persisten Complex Bereavement (PCBD) and prolonged Grief Symptoms (PGD).(Baseline to End of Intervention, up to 3 months)
研究者
Débora González
Principal Investigator
Beckley Med Foundation