tDCS-Augmented Exposure Therapy for Pathological Fear
2020年12月4日 更新者：Michael J. Telch、University of Texas at Austin
This double-blind randomized controlled clinical trial aims to test whether transcranial direct current stimulation (tDCS) can be used to modulate fear extinction learning during exposure therapy for pathological fear, including fear of spiders, snakes, or germs / contamination.
Participation takes place over three laboratory visits, including (1) a pre-treatment visit, (2) a treatment and post-treatment visit, and (3) a 1 month follow-up visit.
During treatment, participants will receive either 20 minutes of active or sham tDCS, followed by 30 minutes of in vivo exposure therapy.
研究概览
地位
完全的
条件
详细说明
In a trans-diagnostic sample with marked pathological fear and behavioral avoidance, this study aims to: (1) evaluate whether excitatory tDCS of the mPFC and inhibitory tDCS of right dlPFC enhances exposure therapy relative to sham tDCS; (2) determine whether tDCS effects are moderated by baseline negative prognostic indicators; and (3) determine whether tDCS effects are mediated by pre-post changes in vigilance to threat, in-session fear reduction, and contextual memory for the exposure context.
If successful, the project may discover a potentially effective exposure therapy augmentation, and may enhance knowledge of the behavioral, cognitive, affective, and neurobiological factors that moderate and mediate acute treatment response and maintenance of treatment gains.
This knowledge may inform treatment development efforts for more debilitating forms of pathological fear.
研究类型
介入性
注册 (实际的)
49
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Texas
-
Austin、Texas、美国、78712
- Laboratory for the Study of Anxiety Disorders
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age 18-65.
- Fluent in English.
- A score on at least 1 fear domain-specific prescreen measure > 2 SDs above the subject pool prescreen mean. These measures include (a) FSQ, and (b) OCI-R.
- Peak fear ≥ 50 on BATs 1 and 2.
Exclusion Criteria:
- Currently receiving treatment for the primary fear domain (based on clinical interview).
- Unstable dose of psychotropic medications within 6 weeks prior to baseline assessment (based on the DMQ; see measures).
- Medical condition that would contraindicate participation in treatment or assessment activities (e.g., cardiovascular problems; based on the DMQ; see measures).
- Pregnancy (based on the DMQ; see measures).
- Current major depressive disorder (based on MINI; see measures).
- Current, or history of bipolar disorder (based on MINI; see measures).
- Current, or history of psychotic symptoms (based on MINI; see measures).
- Serious suicidal risk, as determined by self-report (C-SSRS, BDI-II) and clinical interview (MINI; see measures).
- Active neurological conditions, including seizures, stroke, unexplained loss of consciousness or concussion (based on DMQ and tDCS Safety Screening Form; see measures)
- Contraindications for tDCS: Metal in the head or implanted brain medical devices.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Active tDCS + In Vivo Exposure
Participants assigned to this condition will receive excitatory transcranial direct current stimulation (tDCS) of the left medial prefrontal cortex (lmPFC) and inhibitory tDCS of right dorsolateral prefrontal cortex (rdlPFC).
tDCS will be administered for 20 minutes at 1.7 mA, followed by 30 minutes of in vivo exposure therapy.
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Participants will receive 20 minutes of either active or sham tDCS prior to in vivo exposure to feared targets.
Participants will receive 30 minutes of in vivo exposure to feared targets following either active or sham tDCS
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假比较器：sham tDCS + In Vivo Exposure
Participants assigned to this condition will receive sham transcranial direct current stimulation (tDCS), which will consist of 30 seconds of stimulation at the beginning and end of tDCS administration.
Electrode positioning will be counterbalanced across participants (i.e., either mPFC+ or mPFC-, with same electrode positioning as the active comparators).
Sham tDCS will be administered for 20 minutes, followed by 30 minutes of in vivo exposure therapy.
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Participants will receive 30 minutes of in vivo exposure to feared targets following either active or sham tDCS
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in peak fear during two behavioral approach tasks across time-points.
大体时间：Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
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Subjective units of distress from 0 = no fear, to 100 = extreme fear
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Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
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Change in approach level during two behavioral approach tasks across time points.
大体时间：Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
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Highest difficulty level achieved from 0 = least challenging to 10 = most challenging.
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Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in arachnophobia symptom severity across time-points
大体时间：Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
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Total score on the Fear of Spiders Questionnaire
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Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
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Change in ophidophobia symptom severity across time-points
大体时间：Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
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Total score on the Fear of Snakes Questionnaire
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Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
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Change in germaphobia / contamination fear symptom severity across time points.
大体时间：Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
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Total score on the Obsessive Compulsive Inventory - Revised.
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Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
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Threat vigilance task
大体时间：Before and after tDCS administration (1 week after baseline)
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Computer-based task that assesses attention biases towards and away from threatening images.
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Before and after tDCS administration (1 week after baseline)
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Visuospatial working memory task
大体时间：Before and after tDCS administration (1 week after baseline)
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Delayed match to sample task assessing recognition of 4 x 4 arrays of colored blocks, after a brief delay.
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Before and after tDCS administration (1 week after baseline)
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Incidental contextual memory task
大体时间：Stimulus presented during in vivo exposure (1 week after baseline), and memory assessed at follow-up (1 month after treatment)
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Assessment of incidental memory for a 4 x 4 array of line drawings from the Test of Memory Malingering, presented in the treatment context only during in vivo exposure.
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Stimulus presented during in vivo exposure (1 week after baseline), and memory assessed at follow-up (1 month after treatment)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Adam R. Cobb, Ph.D.、The University of Texas at Austin
- 研究主任：Michael J. Telch, PhD、The University of Texas at Austin
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年1月1日
初级完成 (实际的)
2018年9月6日
研究完成 (实际的)
2018年9月6日
研究注册日期
首次提交
2017年3月20日
首先提交符合 QC 标准的
2017年3月23日
首次发布 (实际的)
2017年3月29日
研究记录更新
最后更新发布 (实际的)
2020年12月8日
上次提交的符合 QC 标准的更新
2020年12月4日
最后验证
2020年12月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 2016-02-0024
计划个人参与者数据 (IPD)
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未定
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不
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