Neurofeedback Therapeutic Intervention For Post-Traumatic Stress Disorder Patients Compared To Treatment As Usual
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Decreased PTSD symptoms measured by change in psychiatric evaluation and PCL score
研究概览
简要总结
Post-traumatic stress disorder (PTSD) is a common debilitating disorder that affects many individuals exposed to aversive events. The severity of PTSD symptoms is positively correlated with amygdala activation. More severe PTSD symptoms following exposure to stressful events, are associated with amygdala hyper-responsivity prior to exposure. A possible intervention for PTSD is Neurofeedback (NF) - a treatment method based on learned self-modulation of neural activity in response to feedback of neural signal. Previous work in our lab established a NF training procedure that utilizes the temporal abilities of EEG with the spatial advantages of fMRI. Further work based on this method using the amygdala BOLD signal (EEG-finger-print, EFP) has demonstrated a potential for improving the ability to self-regulate amygdala activity and to improve emotional regulation in a healthy population. The current study aims to investigate the potential of this method as a therapeutic intervention for PTSD.
详细描述
Pre-treatment phase (one week) Day 1 Participants will arrive at Tel Aviv Sourasky Medical Center (TASMC) and receive an explanation regarding the study and protocol and will sign informed consent. They will then be asked to fill demographic and psychological questionnaires assessing emotion regulation abilities (ERQ), state and trait anxiety (STAI), and questionnaires measuring symptoms of stress, anxiety and depression such as BDI. They will also be interviewed using clinically structured interviews (SCID, CAPS).
All participants will undergo psychiatric evaluation in the trauma clinic at TASMC. The evaluation would also entail medication monitoring.
The participants would be randomized to the three groups NF-T group (N=20), NF-N group (N=20) and treatment as usual (N=20), based on: age (under/over 40) and time since traumatic event (over or under 5 years).
Day 2 All participants will undergo a brain-imaging scan to characterize brain network responses associated with emotional arousal and regulation. Participants will be scanned for functional and structural MRI, which will include ROI localizer for the neurofeedback (NF), resting state and diffusion tensor imaging (DTI). Following which participants of the NF treatment groups will have 1 session of real-time-functional MRI-electric fingerprint neurofeedback (rt-fMRI-EFP NF) session.
Prior to this session a research staff member will explain the course of the MRI testing to the participant, and will enter with the participants into the mock simulator to verify that he or she is lying on their back properly and feel comfortable. During scanning the patient will be presented with visual and auditory stimuli, as well as short video clips. Auditory presentation: stimuli will be heard via MRI -compatible headphones. Visual displays: the participants will view the stimuli through a mirror and projected onto a screen in the magnet room. In between blocks the participants will be given time to rest. Participants will be asked to avoid moving as much as possible during the scans.
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
- None
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
- •Diagnosis of chronic Post traumatic stress disorder (PTSD) (at least one year and two months since diagnosis; diagnosis according to DSM-V, or DSM-VI)
- •Patients must meet the criteria for medical MRI testing set by Tel Aviv Sourasky Medical Center
排除标准
- •Patients diagnosed with another major psychiatric disorder other than PTSD (such as schizophrenia).
- •Patients diagnosed with substance abuse.
- •Any aggravation of PTSD symptoms that requires hospitalization.
- •Patients who are unable to commit to the duration and plan of the study.
- •Patients who meet the criteria for exclusion in medical MRI scans, according to procedures set forth at MRI Medical Center in Tel-Aviv Sourasky. For example, metal that cannot be removed, orthodontal accessories connected to one's teeth, or current systemic diseases.
研究组 & 干预措施
NF-N group
Neurofeedback in a neutral context
干预措施: Neurofeedback (Behavioral)
NF-T group
Neurofeedback in a trauma-related context
干预措施: Neurofeedback (Behavioral)
Control group
Treatment as usual
干预措施: Control (Other)
结局指标
主要结局
Decreased PTSD symptoms measured by change in psychiatric evaluation and PCL score
时间窗: 1-14 weeks
Psychiatric evaluation is based on amount and severity of symptoms according to DSM-IV/V. We will also base change in symptoms on a statistically significant change in PCL (PTSD Check List) score
Reduced amygdala reactivity measured by percent change in BOLD signal
时间窗: 1-14 weeks
次要结局
- Change in Emotion Regulation Questionnaire (ERQ)(1-14 weeks)
- Change in Beck Depression Inventory (BDI-II)(1-14 weeks)
- Change in State/Trait Anxiety Inventory (STAI)(1-14 weeks)