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临床试验/NCT07805070
NCT07805070尚未招募不适用

Uncovering Neurocognitive Mechanisms and Enhancement of Exposure-based Fear Learning With Cognitive Training

University of California, San Diego0 个研究点目标入组 120 人开始时间: 2027年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
Fear extinction

研究概览

简要总结

Anxiety disorders remain are among the most prevalent psychiatric conditions and are associated with negative outcomes spanning poor health to increased suicide risk. While exposure therapy is recognized as a gold standard empirically supported treatment, many individuals fail to achieve adequate response. Exposure therapy is grounded in fear extinction learning models, which suggest that anxiety diminishes when individuals repeatedly confront their fears. To improve exposure-based interventions, it is critical to enhance our understanding of underlying mechanisms of fear extinction and how to better target these mechanisms. Fear extinction requires basic neurocognitive abilities that allow individuals to learn from and adapt to experiences confronting feared situations. Emerging cross sectional and experimental data suggest that working memory is a particularly important neurocognitive process that is associated with fear learning outcomes. By enhancing working memory through experimental manipulations like cognitive training, we may improve the fear extinction learning processes essential for successful exposure therapy. Unlike other neurocognitive enhancements (e.g., medications), computer-based working memory training offers high mechanistic precision, ease of administration, and low cost. The long-term goal of this research is to develop a novel mechanistic understanding of the neurocognitive processes involved in exposure-based fear extinction learning, ultimately aiming to improve interventions for anxiety disorders. This study will test the effects of manipulating working memory prior to a massed exposure paradigm, comparing working memory training plus massed exposure (WMT+Ex) to a sham training plus massed exposure (ST+Ex) condition. Using public speaking anxiety as a clinical exemplar, we will employ a rigorous experimental trial design combined with a validated single-visit speech exposure paradigm to assess fear extinction learning outcomes through multiple measures, including behavioral, physiological, neural, and self-report. The central hypothesis is that WMT+Ex will improve markers of fear extinction learning considered to underlie clinical response in exposure therapy. Specific aims are to 1) determine the extent to which working memory training delivered prior to massed exposure improves behavioral and neural markers of fear extinction learning, and 2) evaluate the effects of working memory training delivered prior to massed exposure on fear extinction learning occurring during exposure. This study is expected to achieve two goals: first, to advance our understanding of the neurocognitive mechanisms of fear extinction through a rigorous experimental design, and second, to validate a combined working memory training and exposure paradigm. If successful in enhancing fear extinction, this approach could be further explored in therapeutic formats to assess its clinical effects.

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
Quadruple (Participant, Care Provider, 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

入选标准

  • fluent in English
  • diagnosis of social anxiety disorder (generalized or performance-only) with Personal Report of Public Speaking Anxiety (PRPSA) score of ≥120 at screening
  • 6-week stability if receiving other (non-anxiety focused) psychosocial treatment

排除标准

  • past 3-mo diagnosis of moderate or greater alcohol or substance use disorder
  • lifetime history of psychotic or bipolar I disorders
  • acute suicidality necessitating immediate clinical intervention
  • neurodegenerative or neurodevelopmental disorders
  • history of neurological condition
  • conditions that are unsafe for MRI (e.g., metal in body)
  • currently receiving psychosocial treatment for anxiety or related condition
  • currently receiving psychiatric pharmacotherapy

研究组 & 干预措施

Cognitive training

Active Comparator

Training to enhance cognitive functioning

干预措施: Cognitive training (Behavioral)

Sham training

Sham Comparator

Computer interface designed to control for general task parameters

干预措施: Cognitive training (Behavioral)

结局指标

主要结局

Fear extinction

时间窗: Change from baseline day 1 to post-intervention day 2

threat expectancy ratings to the CS+ during late extinction learning

Subjective Units of Distress

时间窗: Change from baseline speech to post speech (all within day 1)

Ratings of distress during speeches

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jessica Bomyea

Assoc Prof

University of California, San Diego

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