A Randomized Clinical Trial of Acceptance and Mindfulness-based Exposure Therapy (AMBET) and Present Centered Therapy (PCT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in PTSD symptoms over time
研究概览
简要总结
The goal of this clinical trial is to learn if a new therapy called Acceptance- and Mindfulness-Based Exposure Therapy (AMBET) helps treat post-traumatic stress disorder (PTSD) in people who survived a cardiac arrest. This study will compare AMBET to another psychotherapy treatment called Present Centered Therapy (PCT) to see which therapy is more effective in treating PTSD.
The main questions it aims to answer are:
Does AMBET reduce PTSD symptoms in survivors of cardiac arrest? How do the benefits of AMBET compare to PCT?
Participants will:
- Be randomly assigned to receive either AMBET or PCT
- Attend 12 hours of individual psychotherapy sessions over about 12 weeks
- Complete short weekly surveys about their mood and behaviors online
- Wear a Fitbit device to track sleep and activity during the study
- Do brief homework assignments between sessions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 81 years old at the time of consent
- •Fluency in English
- •Medical history of cardiac arrest >3 months ago
- •Clinically elevated PTSD symptoms (Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score ≥25)
- •U.S. Resident
排除标准
- •Lifetime history of primary psychotic or bipolar disorders
- •Current substance use disorder (moderate or severe in the past 6 months)
- •Active suicidal ideation with some intent to act in past 12 months, and/or suicide attempt in past 24 months
- •Substantial cognitive impairment (Mini Mental Status Exam (MMSE) score <25)
- •Initiation of new psychotropic medication <3 months ago
- •Non-cardiac etiology of CA (drowning, bleeding, trauma, drug overdose, etc)
- •Terminal illness with life expectancy <1 year
- •Concurrent psychotherapy for PTSD
研究组 & 干预措施
Acceptance- and mindfulness-based exposure therapy (AMBET)
Remotely delivered psychotherapy combining exposure therapy with mindfulness.
干预措施: Acceptance and Mindfulness Based Exposure Therapy (Behavioral)
Present-Centered Therapy (PCT)
Remotely delivered psychotherapy that focuses on increasing adaptive responses to current life stressors and difficulties.
干预措施: Present-Centered Therapy (Behavioral)
结局指标
主要结局
Change in PTSD symptoms over time
时间窗: Baseline, At 6 weeks, Post-treatment: Approximately 3 months and 6 months from intake
Change in symptoms as measured by the Clinician Administered PTSD Scale (CAPS-5) from pre- to post-treatment. The full score range is 0 - 80, where lower scores indicate lower symptom levels of PTSD.
次要结局
- Change in depressive symptoms over time(Baseline, At 6 weeks, Post-treatment: approximately 3 months and 6 months from intake)
研究者
Yuval Neria
Professor of Clinical Medical Psychology
Columbia University