Neurofeedback of Amygdala Activity for Post-traumatic Stress Disorder (PTSD)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Change in Control Over the Amygdala
研究概览
简要总结
The primary purpose of this study is to investigate the efficacy of neurofeedback (NF) of real-time functional magnetic resonance imaging (rt-fMRI) data of the amygdala with regards to the reduction of post-traumatic stress disorder (PTSD) symptoms.
A secondary purpose of this study is to use fMRI as a method of investigating brain function in individuals with PTSD. This study approach provides a tool for probing the neurobiology of PTSD by (1) testing the critical role of the amygdala in this disorder, and by (2) examining how amygdala connectivity is related to both amygdala regulation and clinical symptoms.
详细描述
In pursuit of the overarching goals of this study, the investigators aim to:
- determine if an experimental feedback intervention increases control over the region of interest (the amygdala) more than a control feedback intervention in which participants receive feedback that is unassociated with their PTSD symptoms.
- determine if an experimental feedback intervention results in clinical improvements in PTSD symptoms relative to a control feedback intervention, and examine whether these improvements correlate with improved control over the amygdala.
- determine if an experimental feedback intervention results in changes in resting state connectivity to the amygdala, and whether these changes correlate with symptom improvement and an improved ability to regulate the amygdala.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants will be blind to group assignment (experimental feedback intervention or control feedback intervention). The outcome assessor will be blind to group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 and up
- •Diagnosis of chronic PTSD, as established by the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V; CAPS-5)
- •Ability to give signed, informed consent in English
- •Normal or corrected-to-normal vision
- •Participants who are on a stable dose of selective serotonin reuptake inhibitor (SSRI) antidepressants for 2 months (3 months if they are on sertraline), or who have been un-medicated for at least 2 months, will be allowed to participate in this study
- •At the time of recruitment, patients must have no intention of changing their medication or psychotherapy during the 2.5-month period of the intervention
- •Research group must be able to identify a trauma-related target region in or immediately adjacent to the amygdala
排除标准
- •Any primary psychiatric diagnosis of a current major mood disorder, psychotic disorder, autism, mental retardation, or DSM-5 substance use disorder of mild or greater severity (2 or more symptoms) in the past 30 days. Comorbid mood and anxiety disorders will be permitted if they are not the primary focus of clinical attention
- •Any history of psychosis or mania
- •Active suicidality within past year, or history of suicide attempt in past 2 years
- •Any contraindication to MRI scanning (severe claustrophobia, ferromagnetic metal in body, etc.)
- •Pregnancy
- •Any unstable medical or neurological condition
- •Any history of severe past drug dependence (i.e., a focus of clinical attention or a cause of substantial social or occupational difficulty)
- •Any history of brain surgery, of penetrating, neurovascular, infectious, or other major brain injury, of epilepsy, or of other major neurological abnormality (including a history of traumatic brain injury [TBI] with loss of consciousness for more than 24 hours or posttraumatic amnesia for more than 7 days)
- •Significant hearing loss or severe sensory impairment
- •Any psychotropic medication other than a stable dose of selective serotonin reuptake inhibitors (SSRIs)
- •Any change in accepted psychotropic medication within the past 2 months
- •Active engagement in cognitive-behavioral therapy or any evidence-based PTSD psychotherapy (Cognitive Processing Therapy [CPT], Prolonged Exposure [PE], Eye Movement Desensitization and Reprocessing [EMDR]) initiated within the past 3 months; continuation of established maintenance supportive therapy will be permitted
- •Enrollment in another research study testing an experimental/clinical/behavioral intervention intended to affect symptoms initiated within the last 2 months, or intended enrollment within the next 2.5 months
研究组 & 干预措施
Experimental Feedback Intervention
Participants receive real-time feedback during fMRI scans that the investigators believe may help them learn to control their PTSD symptoms.
干预措施: Experimental Feedback (Device)
Control Feedback Intervention
Participants receive real-time feedback during fMRI scans that the investigators do not believe can help their PTSD symptoms.
干预措施: Control Feedback (Device)
结局指标
主要结局
Change in Control Over the Amygdala
时间窗: baseline; 30 day-day follow up
Control over the amygdala will be defined as the change in the blood-oxygen-level dependent (BOLD) signal in the target area (an individually-localized region of interest (ROI) in the amygdala) during down-regulation blocks following symptom provocation relative to rest. Investigators will assess the magnitude of change in control over the amygdala to trauma reminders from baseline to 30-day post treatment follow-up. This measure is based on beta values, which are unitless
次要结局
- Improvements in PTSD Symptoms(Baseline; 60-day follow-up)
- Number of Participants With Changes in Resting State Connectivity to the Amygdala(Baseline; 60 days follow up.)
- Improvements in PTSD Symptoms(Baseline; 30-day follow-up)