Effects of Mindfulness on PTSD: A Community-Based Clinical Trial Among Trauma Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- PTSD Symptoms Checklist (PCL-5)
研究概览
简要总结
The purpose of this randomized control trial is to examine the effects of a Mindfulness-Based Stress Reduction (MBSR) program on women with posttraumatic stress disorder related to intimate partner violence.
详细描述
Posttraumatic stress disorder is a prevalent, chronic, and debilitating disorder characterized by a reduced capacity to adapt to stressors, marked by poor regulation in the following domains: emotion, attentional function, and physiological stress. Mindfulness-based stress reduction (MBSR) holds promise for treating symptoms of trauma and PTSD as evidence suggests it targets these domains. The central hypothesis is that MBSR, which teaches non-judgmental awareness, can improve emotion regulation and attentional function, and diminish physiological stress dysregulation, which in turn will improve PTSD symptoms. We will examine changes in stress capacity and PTSD symptom severity among women survivors of intimate partner violence with PTSD after participation in an MBSR program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English-speaking
- •18-64 years of age
- •Victim of IPV
- •Meet diagnostic criteria for PTSD
- •No or stable use of medications (including, for example, beta blockers).
排除标准
- •There is suspicion or evidence of dementia or cognitive impairment (Mini-Mental State Examination score < 24) or inability to provide informed consent
- •They have ever been a perpetrator of IPV
- •History of schizophrenia or bipolar I disorder; current suicidality with either plan, intent, or a suicide attempt in the past 6 months
- •Active substance dependence or in remission < 3 months
- •Cardiovascular conditions (e.g., congestive heart failure, pacemaker, prior myocardial infarction)
- •The age range was chosen to reduce heterogeneity in this pilot study, as aging is associated with changes in emotion regulation, attention, and PNS tone.
研究组 & 干预措施
Mindfulness-based stress reduction
The MBSR program is a manualized course that includes meditation, relaxing movement, and breathing. A certified MBSR instructor will teach the courses in a group-based format for 120 minute sessions, once per week for eight weeks.
干预措施: Mindfulness-based stress reduction (Behavioral)
Wellness Group
The Wellness control group uses a health education manual that provides information on various aspects of health, including diet, physical activity, sleep, stress management, and communication. The manual is used during weekly check-in phone calls for an 8-week period.
干预措施: Wellness Group (Behavioral)
结局指标
主要结局
PTSD Symptoms Checklist (PCL-5)
时间窗: 12 weeks
The PTSD Symptoms Checklist (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 asks respondents to rate how much they have been bothered by particular PTSD symptoms in the past month on a 0-4 scale.
次要结局
- Useful Field of View Test (UFOV)(12 weeks)
- Five-Facet Mindfulness Questionnaire (FFMQ)(12 weeks)
- Difficulties in Emotion Regulation Scale (DERS)(12 weeks)
- Heart rate variability(12 weeks)
研究者
Autumn Gallegos
Assistant Professor
University of Rochester