Self-regulation of Post-traumatic Stress Disorder (PTSD) Neurocircuitry Using Multiple Sessions of Real-Time Functional Magnetic Resonance Imaging (RtfMRI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Region-of-interest (ROI) downregulation analysis over neurofeedback training sessions
研究概览
简要总结
Post-traumatic stress disorder (PTSD) is a debilitating and highly prevalent psychiatric disorder that develops in the aftermath of trauma exposure (APA, 2013). PTSD has been strongly associated with altered activation patterns within several large-scale brain networks and, as such, it has been suggested that normalizing pathological brain activation may be an effective treatment approach.
The objective of this proposed study is to investigate the ability of PTSD patients to self-regulate aberrant neural circuitry associated with PTSD psychopathology using real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback. Here, the investigators are building upon previous single-session pilot studies examining the regulation of the amygdala and the posterior cingulate cortex (PCC) in PTSD (Nicholson et al., 2021) (Nicholson et al., 2016) by: (1) Examining the effect of multiple sessions of rt-fMRI neurofeedback and, (2) Comparing PCC- and amygdala-targeted rt-fMRI neurofeedback to sham-control groups with regards to changes in PTSD symptoms and neural connectivity.
详细描述
Overview of Study Procedure:
This study consists of the following components:
- Clinical assessment
- 5 x self-report symptom assessment battery that will be administered electronically via REDCap (Research Electronic Data Capture), a secure web application for building and managing online surveys and databases.
- 3 x rt-fMRI neurofeedback sessions, plus a 30-minute semi-structured qualitative interview immediately after the end of scanning with a trauma-informed and clinically trained graduate student
- 7 weeks of actigraphy device usage to monitor participant biological (sleep) rhythms and physical activity.
(1) Clinical Assessment: Those who meet criteria for inclusion will be scheduled for baseline clinical assessments. Baseline clinical assessments will include the Mini-International Neuropsychiatric Interview (MINI; (Sheehan et al., 1998), and the Clinician-Administered PTSD Scale-5 (CAPS-5; (Weathers et al., 2018). The MINI will be used to establish mental health disorder diagnoses, and the CAPS will be used to establish a primary diagnosis of PTSD and symptom severity. In keeping with previous single-session studies by our group (Nicholson et al., 2016; 2021), during the clinical assessment session PTSD participants will be asked to select personalized trauma-associated words that induce emotional responses as well as neutral words associated with neutrally salient memories. The chosen words will be utilized for the emotion induction paradigm during neurofeedback. To ensure that the words only induce moderate emotional arousal, participants will self-report levels of distress associated with viewing the words and selection will be limited to words with a maximum distress rating of 7/10.
(2) Self-report Assessments (via REDCap): In this study, participants will also complete a battery of self-report questionnaires prior to the first neurofeedback session, including: Life Events Checklist (LEC-5) (Weathers et al., 2013), Beck Depression Inventory (BDI) (Beck et al., 1997), Childhood Trauma Questionnaire (CTQ) (Bernstein et al., 2003), Difficulties in Emotion Regulation Scale (DERS) (Perasso & Velotti, 2017), Multiscale Dissociation Inventory (MDI) (Briere et al., 2005), the Depression Anxiety Stress Scale-21 (DASS-21) (Lovibond & Lovibond, 1995), the Multidimensional Assessment of Interoceptive Awareness (MAIA) (Mehling et al., 2012), the Insomnia Severity Index (ISI) (Morin et al., 2011), and the PTSD Checklist for DSM-5 (PCL-5) (Blevins et al., 2015). The PCL-5, BDI, DERS, MDI, DASS-21, ISI, and MAIA will be completed again after each rt-fMRI session, as well as at a 1- month follow-up. This battery of questionnaires will be administered at each time interval via REDCap.
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
Both investigators and participants will be blinded with regards to arm assignment.
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
- •18-65 years old
- •Fluent English speaker
- •Comfortable using electronic devices (i.e., laptop, tablet, smartphone, etc.)
- •Meet criteria for a primary diagnosis of PTSD via the DSM-5 on the Clinician Administered PTSD Scale (CAPS-5). Note: given high rates of PTSD co-morbidity with major depressive disorder and anxiety disorders, these participants will not be excluded from the study, allowing for a naturalistic sample
- •Able to provide written informed consent.
排除标准
- •Pregnant women or women who are breastfeeding
- •Serious illness (including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease) that is not stabilized based on the judgment of primary investigator
- •Contraindications for research MRI, including metallic implants
- •Neurological disease, past head injury with loss of consciousness, stroke, seizures
- •Major untreated medical illness (e.g., cancer, thyroid disorder)
- •Any other condition that might interfere with the person's capacity to give informed consent, or to adhere to the study protocol.
- •Psychological/Psychiatric
- •Active substance use or abuse as defined by the MINI or judged to be a problem by the PI
- •Current or past pain disorders, bipolar disorders or psychosis, schizophrenia, and any other psychotic disorder will be excluded
- •Participants will also be excluded for active suicidality, history of pervasive developmental disorders, or any other major medical illnesses
- •Meeting criteria for substance use disorder in the past three months on the MINI
- •Chronic opioid analgesic use within the last three months
- •Any other condition that might interfere with the person's capacity to give informed consent, or to adhere to the study protocol
- •Current engagement in a primary trauma-focused psychotherapy treatment.
- •History of claustrophobia
- •Previous engagement in biofeedback, neurofeedback, or any form of brain stimulation therapy.
结局指标
主要结局
Region-of-interest (ROI) downregulation analysis over neurofeedback training sessions
时间窗: Change in ROI activation between neurofeedback sessions 1, 2, and 3
In order to evaluate ROI downregulation (i.e., neurofeedback success), we will extract the event-related BOLD signal from the ROI during the regulate and view conditions.
Changes in PTSD symptoms over neurofeedback training sessions
时间窗: Change in baseline (pre-neurofeedback) at 1-week intervals (i.e., post-neurofeedback session 1, 2, 3) and at a 1-month follow-up)
The change in PTSD symptoms, as measured by PTSD Checklist 5 (PCL-5) scores, will be assessed over the course of 3 neurofeedback training sessions and at a 1-month follow-up. PCL-5 is a self-report measure used to gauge the DSM-5 symptoms of PTSD. PCL-5 scores range from 0 to 80 with higher scores indicating more severe PTSD symptoms.
次要结局
- Change in sleep difficulties (i.e., ISI) over neurofeedback training sessions(Change in baseline (pre-neurofeedback) at 1-week intervals (i.e., post-neurofeedback session 1, 2, 3) and at a 1-month follow-up))
- Changes in physical activity (i.e., actigraphy) over neurofeedback training sessions(Data collection will span 7-weeks during the study (i.e., 1-week baseline before neurofeedback session #1, 1-week between neurofeedback sessions #1 and #2, 1-week between neurofeedback sessions #2 and #3, 1-month follow-up after neurofeedback session #3))
- Change in depressive symptoms (i.e., BDI-II) over neurofeedback training sessions(Change in baseline (pre-neurofeedback) at 1-week intervals (i.e., post-neurofeedback session 1, 2, 3) and at a 1-month follow-up))
- Change in trauma-related memory recall (i.e., RSDI) over neurofeedback training sessions(Change in baseline (pre-neurofeedback) at 1-week intervals (i.e., post-neurofeedback session 1, 2, 3) and at a 1-month follow-up))
- Change in dissociation symptoms (i.e., MDI) over neurofeedback training sessions(Change in baseline (pre-neurofeedback) at 1-week intervals (i.e., post-neurofeedback session 1, 2, 3) and at a 1-month follow-up))
- Change in emotional states of depression, anxiety, and stress (i.e., DASS-21) over neurofeedback training sessions(Change in baseline (pre-neurofeedback) at 1-week intervals (i.e., post-neurofeedback session 1, 2, 3) and at a 1-month follow-up))
- Change in interoceptive awareness (i.e., MAIA) over neurofeedback training sessions(Change in baseline (pre-neurofeedback) at 1-week intervals (i.e., post-neurofeedback session 1, 2, 3) and at a 1-month follow-up))
- Change in emotion regulation abilities (i.e., DERS) over neurofeedback training sessions(Change in baseline (pre-neurofeedback) at 1-week intervals (i.e., post-neurofeedback session 1, 2, 3) and at a 1-month follow-up))
- Changes in biological (sleep) rhythms (i.e., actigraphy) over neurofeedback training sessions(Data collection will span 7-weeks during the study (i.e., 1-week baseline before neurofeedback session #1, 1-week between neurofeedback sessions #1 and #2, 1-week between neurofeedback sessions #2 and #3, 1-month follow-up after neurofeedback session #3))
研究者
Andrew Nicholson
Adjunct Professor
Lawson Health Research Institute