Exploring the Influence of Neurofeedback on the Well-Being of People With Symptoms of Obsessive Compulsive Disorder and Post-traumatic Stress Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Dissociative Symptoms Scale (DSS)
研究概览
简要总结
The proposed study will collect novel data evaluating the feasibility of a neurofeedback training program delivered to prospective clients with a history of clinically concerning trauma-related mental health symptoms who are on a wait list to receive obsessive compulsive disorder-specific psychotherapy at an outpatient mental health clinic. This study will evaluate the influence of neurofeedback training on participant's overall sense of well-being, and additionally, whether any enhanced well-being is subsequently associated with positive changes in symptoms of obsessive compulsive disorder, post-traumatic stress, dissociation and other trauma-related mental health symptoms, emotional regulation, etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •being a client placed on the clinic waitlist to receive exposure-response prevention for OCD symptoms at the Anxiety and OCD Treatment Center of Ann Arbor, in Ann Arbor, MI.
- •having self-reported symptoms of OCD;
- •having post-traumatic stress symptoms as indicated by a score of 3 or higher on the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) screening measure;
- •being age 18+.
- •being a citizen of the United States of America -
排除标准
- •a lifetime history of significant untreated mental illness (not currently treated schizophrenia, schizoaffective disorder, bipolar disorder, or substance use disorder) or neurological or pervasive developmental disorder;
- •a documented history of epilepsy;
- •lifetime history of any head injury with loss of consciousness;
- •current exposure domestic or intimate partner violence or otherwise state that their current living conditions are unsafe;
- •current experiences of psychosis or suicidality within the last six months;
- •currently taking, or in the past month has taken benzodiazepines, narcotic drugs, or cannabis;
- •currently pregnant
- •engagement in self-harming behaviors in the last 3 months that required medical attention;
- •lack of competence to understand or consent to the study procedures;
- •lack of fluency in written and spoken English. -
研究组 & 干预措施
Neurofeedback Training
Participants in the Neurofeedback Training group will complete per-training, post-training, and post-training follow-up self-report surveys assessing overall well-being, symptoms of obsessive compulsive disorder, post-traumatic stress, OCD, dissociation and other trauma-related mental health symptoms, emotional regulation, etc. Participants in this group will all be on a wait list to receive obsessive compulsive disorder-specific psychotherapy at a local outpatient therapy clinic that specializes in the treatment of anxiety and obsessive compulsive disorders. All participants will demonstrate clinically significant post-traumatic stress symptoms and have a self-reported diagnosis of obsessive compulsive disorder.
干预措施: Neuroptimal (Zengar, Inc.) Neurofeedback (Device)
结局指标
主要结局
Dissociative Symptoms Scale (DSS)
时间窗: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.
This 20-item measure evaluates moderate to severe levels of dissociative symptoms in four main domains: depersonalization, derealization, gaps in awareness or memory, and dissociative reexperiencing symptoms. Scores range from 0-80, with higher scores indicating worse outcomes.
Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fith Edition (PTSD Checklist for DSM-5 - Standard).
时间窗: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.
This measure evaluates symptoms of post-traumatic stress. Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome.
Yale-Brown Obsessive Compulsive Scale (Y-BOCS; with Checklist)
时间窗: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.
10-item measure evaluating severity of obsessive compulsive symptoms, with an accompanying checklist of symptom types. Scores range from 0-40 with higher scores indicating worse outcomes. Symptoms on the checklist are categorized, and indicate different OCD symptom clusters or sub-types that respondents may experience.
Difficulties in Emotion Regulation Scale (DERS)
时间窗: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.
36-item measure evaluating challenges with emotional regulation. Scores range from 36-180, with higher scores indicating worse outcomes.
The World Health Organization-Five Well-Being Index (WHO-5)
时间窗: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.
5-item measure evaluating overall well-being. Scores range from 0-25, with higher scores indicating better outcomes.
Patient Health Questionnaire - 8 (PHQ-8)
时间窗: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.
8-item measure evaluating depressive symptoms. Scores range from 0-24, with higher scores indicating worse outcomes.
GAD-7
时间窗: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.
7-item measure evaluating anxiety symptoms. Scores range from 0-21, with higher scores indicating worse outcomes.
Everyday Discrimination Scale
时间窗: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.
9-item measure evaluating experiences of discrimination. Scores range from 9-54, with higher scores indicating more frequent experiences of discrimination.
Difficulties in Emotion Regulation Scale (DERS)
时间窗: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.
36-item measure evaluating challenges with emotional regulation. Scores range from 36-180, with higher scores indicating worse outcomes.
The World Health Organization-Five Well-Being Index (WHO-5)
时间窗: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.
5-item measure evaluating overall well-being. Scores range from 0-25, with higher scores indicating better outcomes.
Patient Health Questionnaire - 8 (PHQ-8)
时间窗: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.
8-item measure evaluating depressive symptoms. Scores range from 0-24, with higher scores indicating worse outcomes.
GAD-7
时间窗: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.
7-item measure evaluating anxiety symptoms. Scores range from 0-21, with higher scores indicating worse outcomes.
Everyday Discrimination Scale
时间窗: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.
9-item measure evaluating experiences of discrimination. Scores range from 9-54, with higher scores indicating more frequent experiences of discrimination.
Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fith Edition (PTSD Checklist for DSM-5 - Standard).
时间窗: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.
This measure evaluates symptoms of post-traumatic stress. Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome.
Dissociative Symptoms Scale (DSS)
时间窗: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.
This 20-item measure evaluates moderate to severe levels of dissociative symptoms in four main domains: depersonalization, derealization, gaps in awareness or memory, and dissociative reexperiencing symptoms. Scores range from 0-80, with higher scores indicating worse outcomes.
Yale-Brown Obsessive Compulsive Scale (Y-BOCS; with Checklist)
时间窗: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.
10-item measure evaluating severity of obsessive compulsive symptoms, with an accompanying checklist of symptom types. Scores range from 0-40 with higher scores indicating worse outcomes. Symptoms on the checklist are categorized, and indicate different OCD symptom clusters or sub-types that respondents may experience.
次要结局
未报告次要终点
研究者
Lisa S. Panisch, PhD, MSW
Assistant Professor
Wayne State University