Treating Phobia With Multivoxel Neuro-reinforcement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change in Amygdala Reactivity
研究概览
简要总结
Specific phobias and other anxiety disorders represent a major mental health problem, and present a significant challenge to researchers because effective treatment usually involves repeated exposure to feared stimuli, and the high levels of associated distress can lead to termination of treatment. Recent advances in computational functional magnetic resonance imaging (fMRI) provide a method by which individuals may be unconsciously exposed to fearful stimuli, leading to effective fear reduction while eliminating a primary cause of attrition.
The objective of the current study is to use the novel approach of neuro-reinforcement based on decoded fMRI information to reduce fear responses to fearful stimuli (e.g., spiders, heights) in individuals with phobias, directly and unconsciously in the brain, without repeatedly exposing participants to their feared stimuli.
Participants will be randomized into one of three groups of varying neuro-reinforcement sessions (1, 3, or 5). They will complete tests of subjective fear and directed attention while being scanned by fMRI to measure engagement of amygdala activity to fearful stimuli as well as measured through other indicators of fear such as skin conductance response.
详细描述
Anxiety disorders, the most common group of mental disorders in the United States, represent a major mental health problem. Phobias, in which fear and anxiety are triggered by a specific stimulus or situation, are the largest category of anxiety disorders and affect 5 - 12% of the world's population.
Exposure-based therapies are effective in reducing symptoms, but their effectiveness depends on the individual's capacity or willingness to consciously confront their feared object. The associated distress can be so extreme that it prevents patients from seeking treatment, and contributes to attrition from exposure once treatment begins. As a result, there is an unmet need for treatment that minimizes attrition and subjective patient discomfort.
The current study uses a novel technique of neuro-reinforcement based on decoded fMRI information to reduce fear responses to fearful stimuli directly and unconsciously without repeatedly exposing participants to those stimuli. The goals are to (1) confirm that our method decreases amygdala reactivity to images of phobic stimuli as well as (2) determine dosage-response optimization.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Individual has normal or corrected to normal vision
- •Individual has normal or corrected to normal hearing
- •Individual is competent to understand informed consent
排除标准
- •Individual is unable to fill in consent form correctly
- •Individual is unable to respond adequately to screening questions
- •Individual is unable to maintain focus or to sit during assessment
- •Individual has history of: neurological disease or defect (e.g., stroke, traumatic brain injury, schizophrenia or other psychological disorders, or seizures)
- •Individual has vision problems (including cataracts, amblyopia, or glaucoma)
- •Individual presents with: PTSD, Obsessive Compulsive Disorder, Substance Use Disorder, Current Major Depression, Bipolar Disorder, Psychosis, neurologic diagnoses or unstable serious medical conditions
- •Individual does not present with more than one object of specific phobia
- •Individual can touch the phobic object category during the pre¬treatment Behavioral Approach Test without presenting significant distress
- •Individual is currently prescribed psychotropic medication
结局指标
主要结局
Change in Amygdala Reactivity
时间窗: 10 days (measured at pre-treatment and post-treatment)
The neural measure of difference in amygdala reactivity (measured by fMRI) to target phobic animals compared to control phobic animals from pre-treatment to post-treatment. Lower numbers (i.e. more negative numbers) indicate greater amygdala decrease and and better outcomes.
Subjective Fear Post-treatment Minus Pre-treatment
时间窗: 10 days (measured at pre-treatment and post-treatment)
Subjective Fear Ratings of images of targeted phobic stimuli Minimum score of 0, Maximum score of 180, higher scores mean worse outcome.
次要结局
- Skin Conductance Response: Physiological Arousal Post-treatment Minus Pre-treatment(10 days (measured at pre-treatment and post-treatment))
- Fear Survey Schedule(10 days (measured at pre-treatment and post-treatment))
- Stroop Task Post-treatment Minus Pre-treatment(10 days (measured at pre-treatment and post-treatment))
研究者
Michelle Craske
Professor
University of California, Los Angeles