Neurofeedback Enhanced Cognitive Reappraisal Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in Prefrontal Cortex (PFC) Activity (Baseline to Transfer Run) From the Reappraise > Look Contrast on the Emotion Regulation Task (ERT)
研究概览
简要总结
This study seeks to understand emotion regulation in those 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 increase 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
- Prefrontal cortex activation will positively correlate with CR ability
详细描述
Due to an unforeseen error in our online neurofeedback script, in which the location of the brain region being targeted was not properly read by the script, participants in the veritable-NF group received feedback to the medial parietal cortex (MPC) instead of the PFC. A third, unrandomized arm has been added to this registration to enroll an additional subset of participants who are indeed receiving feedback to the PFC. The pre-existing veritable-NF arm has been relabeled to reflect which region of the brain was actually targeted. Additionally, the masking description has been reset to "None".
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
- None (Participant, Care Provider)
盲法说明
(Veritable-NF (MPC) and Sham-NF only): All staff present during the MRI session, as well as the participant, will be blinded to group assignment. A designated member of the study team will remain unblinded during the duration of the study.
入排标准
- 年龄范围
- 18 Years 至 55 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 the 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
- •Hormonal contraceptives of any type for any duration
- •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
结局指标
主要结局
Change in Prefrontal Cortex (PFC) Activity (Baseline to Transfer Run) From the Reappraise > Look Contrast on the Emotion Regulation Task (ERT)
时间窗: Approximately 60 minutes
The PFC was defined in MNI space using significant group level activation in the posterior medical frontal cortex from the reappraise\>look contrast from earlier pilot subjects. Percent signal change in this region was extracted for all participants. Change in PFC activity was calculated as the linear slope of change across all 5 runs of the task. To this end, a linear regression was conducted for each participant separately with "run" as the independent variable and "PFC percent signal change" as the dependent variable to calculate change in percent signal change over time. These slopes were then averaged for each group .
Difference in Negative Affect Ratings of Images From International Affective Picture System (IAPS)
时间窗: Within 10 minutes of exiting the scanner
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 along this scale. Differences in SAM ratings from look to reappraise trials (e.g., average reappraise score minus average look score) will be evaluated and compared between sham-NF and veritable-NF groups. Higher difference score indicates that images viewed during reappraisal are seen as more positive than those viewed during the look condition.
次要结局
- Change in Amygdala-PFC Functional Connectivity (Baseline to Transfer) From Reappraise > Look Contrast(Each run is approximately 9 minutes long. Run 5 starts approximately 30 minutes after the completion of run 1.)
研究者
Stefanie Russman Block
Clinical Assistant Professor of Psychiatry
University of Michigan