Neurofeedback Enhanced Cognitive Reappraisal Training - Phase 4
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change in prefrontal cortex (PFC) activity (baseline to transfer run) from the reappraise > look contrast
研究概览
简要总结
This study seeks to understand emotion regulation in those with young adults with anxiety using real-time functional magnetic resonance imaging neurofeedback, a tool that allows individuals to control brain activity. The goal of this project is to understand how receiving feedback about one's own brain activity relates to emotion regulation ability. This work will help the study team understand the brain areas involved in emotion regulation and could lay the groundwork to test if psychotherapy outcomes can be enhanced using neurofeedback.
The study hypotheses include:
- Participants receiving veritable-Neurofeedback (NF) will show a greater activation increases in the prefrontal cortex (PFC) compared to sham-NF
- Participants receiving veritable-NF will show greater cognitive reappraisal (CR) ability compared to those receiving sham-NF
- PFC activation will positively correlate with CR ability
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis (primary source of distress and/or interference) of generalized anxiety disorder, social anxiety disorder, panic disorder or illness anxiety disorder based on structured interview. Comorbid phobic disorders allowed, but these cannot be the primary source of interference or distress due to the lowered chances of encountering anxiety-provoking stimuli during the study period
- •Score of 2 or more on at least 1 question from GAD/CROSS-AD composite
- •Medically and physically able to consent
- •Not regularly taking any medication, prescription or non-prescription, with psychotropic effects other than:
- •Buspirone, or antidepressant (e.g., selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)) with stable dosage for past 4 weeks
- •The same oral hormonal contraceptive for at least 3 months
- •For females, not currently pregnant or actively trying to become pregnant
- •Ability to tolerate small, enclosed spaces without anxiety
- •No metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition (per protocol)
- •Size compatible with scanner gantry (per protocol)
排除标准
- •Current diagnosis of Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, or Bipolar Disorder
- •Current substance abuse or dependence (past 6 months)
- •Active suicidality with plan or intent
- •Current psychosis
- •History of serious neurological illness or current medical condition that could compromise brain function, such as liver failure
- •History of closed head injury, e.g., loss of consciousness greater (>) approximately (~) 5 minutes, hospitalization, neurological sequela
研究组 & 干预措施
Veritable-NF
干预措施: Functional magnetic resonance imaging (fMRI) with Veritable-NF (Other)
Sham-NF
干预措施: fMRI with Sham-NF (Other)
结局指标
主要结局
Change in prefrontal cortex (PFC) activity (baseline to transfer run) from the reappraise > look contrast
时间窗: Approximately 60 minutes
Change in negative affect ratings of images from the International Affective Picture System (IAPS)
时间窗: Approximately 60 minutes
The Self-Assessment Manikin (SAM) is a pictorial assessment technique in which a changing manikin figure depicts values along the primary dimension of affective valence (positive/negative). Users may indicate emotional reactions along a scale from 1-9, with higher numbers indicating greater negative affect. After the scan, participants will rate each image they saw from the IAPS along this scale. Differences in SAM ratings from look to reappraise trials will be evaluated and compared between sham-NF and veritable-NF groups.
次要结局
- Change in amygdala-PFC functional connectivity (baseline to transfer) from reappraise > look contrast(Approximately 60 minutes)
研究者
Stefanie Russman Block
Clinical Assistant Professor of Psychiatry
University of Michigan