Train Your Brain: A Neurofeedback Intervention for Individuals With Post-Traumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change from baseline PTSD severity using the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-5
研究概览
简要总结
The investigator's aim is to evaluate the efficacy of two types of neurofeedback treatments for PTSD symptoms reduction. Half of the participants will receive the current standard for PTSD neurofeedback care undergoing alpha/theta neurofeedback regulation. The other half will receive the newly developed limbic modulation index neurofeedback.
详细描述
Traumatic stress is commonly resistant to existing therapeutics, possibly due to high treatment dropout rates along with a failure to target the relevant underlying neural mechanisms. Neuromodulation of deep limbic areas such as the amygdala may play a critical role in the effective recovery from traumatic stress. Human studies have shown the importance of such modulation during the encoding of traumatic stimuli, showing greater amygdala activation for subsequently remembered traumatic stimuli. In addition, a prospective study among previously healthy soldiers showed that hyper-activation of the amygdala prior to military traumatic exposure corresponded with more severe post-traumatic symptoms following exposure.
Together these finding points to the amygdala as a plausible neuromodulation target for preventive or early interventions of post-traumatic disturbances. Local neuromodulation of the amygdala could improve treatment specificity and the overall intervention outcome.
The main goal of the suggested research is to further develop and implement a non-invasive, portable and cost-effective brain-imaging tool that will provide individual on-line guidance for amygdala modulation. This closed-loop brain training will enhance individual resilience to and coping with potentially traumatic stress as well as alleviate consequential psychopathologies.
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
- Double (Participant, Investigator)
盲法说明
The eBrainFit Platform is set to randomize each entered Subject Identification Number into either the alpha/theta or limbic modulation treatment arms. Neither the participant nor researcher will know the arm, to which the participant has been assigned.
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
- 否
入选标准
- •Previous diagnosis of PTSD
- •PTSD symptoms within the last 30 days
排除标准
- •Any active psychosis or suicidal intent
- •A severe traumatic brain injury (one in which consciousness was lost for greater than 6 hours)
- •Any of the following neurological disorders: Parkinson's, Alzheimer's, Brain Tumor, or Brain Lesion.
结局指标
主要结局
Change from baseline PTSD severity using the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-5
时间窗: administered at Initial Appointment (Week 0) and one week after the 15th neurofeedback session (approximately Week 22).
The five-point CAPS-5 symptom severity rating scale is used for all symptoms. Rating scale anchors should be interpreted and used as follows: 0 Absent The respondent denied the problem or the respondent's report doesn't fit the DSM-5 symptom criterion. 1. Mild / subthreshold: 2. Moderate / threshold: 3. Severe / markedly elevated: 4. Extreme / incapacitating: CAPS-5 total symptom severity score is calculated by summing severity scores for items 1-20. CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms contained in a given DSM-5 cluster.
次要结局
- Emotion Regulation Questionnaire(administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22))
- Beck Depression Inventory(administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22))
- Beck Anxiety Inventory(administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22))
- PTSD Checklist for DSM-5(administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22))
- Sleep Duration(administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22))
- Emotional Stroop Task(administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22))
研究者
Jeremy Goldbach
Professor
University of Southern California