tDCS-Augmented Exposure Therapy for Pathological Fear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Change in peak fear during two behavioral approach tasks across time-points.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, treatment administrators, and outcome assessors will be blind to tDCS condition.
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
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in peak fear during two behavioral approach tasks across time-points.
时间窗: Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
Subjective units of distress from 0 = no fear, to 100 = extreme fear
Change in approach level during two behavioral approach tasks across time points.
时间窗: Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
Highest difficulty level achieved from 0 = least challenging to 10 = most challenging.
次要结局
- Change in ophidophobia symptom severity across time-points(Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment))
- Change in germaphobia / contamination fear symptom severity across time points.(Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment))
- Incidental contextual memory task(Stimulus presented during in vivo exposure (1 week after baseline), and memory assessed at follow-up (1 month after treatment))
- Change in arachnophobia symptom severity across time-points(Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment))
- Threat vigilance task(Before and after tDCS administration (1 week after baseline))
- Visuospatial working memory task(Before and after tDCS administration (1 week after baseline))
研究者
Michael J. Telch
Professor of Psychology
University of Texas at Austin