Mechanistic Pathways of Mindfulness Meditation in Post-traumatic Stress Disorder.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Attentional Network Task: conflict effect score
研究概览
简要总结
The purpose of this study is to find out how meditation influences certain systems in the body: nervous system, hormonal system, and respiratory system. Another purpose is to see how meditation may help improve post-traumatic stress disorder symptoms.
详细描述
This study requires nine visits to the clinic: one screening visit, one baseline visit, six training sessions, and one endpoint visit. There will be approximately 100 people enrolled in this study who will be randomly allocated to one of four groups: a slow breathing group, a meditation group, a meditation plus slow breathing group and a sitting quietly group.
Participants will undergo a telephone screening, a screening visit, baseline visit, six intervention visits (once per week for six weeks), and one endpoint visit (one week after the final training visit). A telephone screening and screening visit will ensure participant eligibility. The screening visit included structured clinician interviews on PTSD symptoms and other mental health disorders, completion of questionnaires, and receipt of home saliva collection kit. At the baseline visit, electrodes will be attached to measure the electrical activity of head, chest, skin, and respiration and blood pressure during a computer task. Intervention visits include slow breathing, meditation, mediation and slow breathing, or sitting quietly depending on which group the participant is allocated to. Breathing rates and other electrical activity of the body will be measured also. Breathing rate will be measured with an elastic band that is placed around the chest. Electrical activity will be measured by the electrodes that will be placed on the scalp, chest and skin. The endpoint visit will be exactly the same as the baseline visit.
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 (Investigator)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Combat veteran (defined by a score of ≥7 on the Combat exposure scale)
- •Chronic PTSD diagnosis
- •Age range (25-65 years)
- •Both genders
- •Good general medical health
- •Stable dose of medications for concurrent stable medical conditions for at least 4 weeks prior to start of the study.
- •Willing and able to provide informed consent.
排除标准
- •Significant chronic medical illness including:
- •current cancer treatment,
- •unstable angina,
- •recent myocardial infarction,
- •current or past history of stroke,
- •transient ischemic attack,
- •congestive heart failure,
- •chronic renal or hepatic failure,
- •hypothyroidism
- •Psychiatric or behavioral illness including:
- •schizophrenia,
- •schizoaffective disorder,
- •bipolar disorder,
- •psychotic disorder (not including transient dissociative states or flashbacks associated with PTSD re-experiencing symptoms),
- •any DSM-IV cognitive disorder,
- •current delirium,
- •psychiatric instability or situational life crises, including evidence of being actively suicidal or homicidal, or any behavior which poses an immediate danger to the patient or others.
- •Substance dependence disorder within 3 months of the study or
- •current substance use other than alcohol (no more than 2 drinks/day by self-report)
- •Sexual assault as primary PTSD event/s.
- •Planning to move from the area in the next year.
- •Prior or current meditation practice.
结局指标
主要结局
Attentional Network Task: conflict effect score
时间窗: Change from Baseline to Endpoint visit (one week after last training visit)
Awakening cortisol values
时间窗: Change from Baseline to Endpoint visit (one week after last training visit)
Post-traumatic stress disorder checklist-hyperarousal score
时间窗: Change from Baseline to Endpoint visit (one week after last training visit)
次要结局
- Intrusive Thought Scale(Change from Baseline to Endpoint visit (one week after last training visit))
- Heart rate(Change from Baseline to Endpoint visit (one week after last training visit))
- EEG event-related negativity during Attentional Network Task(Change from Baseline to Endpoint visit (one week after last training visit))
研究者
Helane Wahbeh
Assistant Professor
Oregon Health and Science University