Neurocognitive Targets of Hostile Interpretation Bias Training to Treat Irritability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Neural Response in Threat Learning System.
研究概览
简要总结
Hostile interpretation bias may be a feature of severe, chronic irritability in children, one of the most common psychiatric symptoms of childhood. Interpretation bias training (IBT) is a computer-based training program that may reduce irritability in youths. This trial lays the groundwork for a test IBT on irritability.
详细描述
This trial lays the foundation for a preliminary test of efficacy of IBT on irritability by establishing IBT's neurocognitive treatment targets: hostile interpretation bias and response in the neural threat-learning system.
The design is a single-blinded, randomized controlled trial of IBT on its targets. The study will have four arms, with 25 participants in each arm for all four conditions of training (active versus sham) and scanning (in MRI or out of MRI scanner). During IBT, participants judge as happy or angry facial expressions which are on a continuum between happy and angry. The point at which judgments shift from predominantly happy to angry on this continuum is the indifference point. During training feedback encourages no change in the indifference point or a change in the indifference point towards more happy judgments of ambiguous faces. A shift in indifference point towards more benign judgments is interpreted as a reduction in hostile interpretation.
The design will test whether active relative to sham IBT shifts the indifference point towards more benign judgments. Neural response to active versus sham IBT will be measured in half the sample.
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
- Single (Participant)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents in mental health treatment, with at least:
- •mild, clinically significant irritability, and
- •typical intellectual functioning (IQ>80)
排除标准
- •Any of the following mental health diagnoses:
- •current post-traumatic stress
- •lifetime bipolar I or II disorder
- •lifetime cyclothymic disorder
- •lifetime psychotic disorder
- •lifetime autism spectrum disorder
- •Major medical problems, including head trauma.
- •MRI-specific safety exclusions for the MRI arms.
- •Clinical instability.
结局指标
主要结局
Neural Response in Threat Learning System.
时间窗: During the course of the 1 day single session of interpretation bias training session.
Amygdala functional connectivity to ventromedial prefrontal cortex is measured by covariance in fluctuations in blood oxygen-level dependent signal between these regions during functional magnetic resonance imaging (fMRI) during the course of training. The outcome measure is a count of these randomized participants for whom the fMRI measure is valid for the planned connectivity analysis. These participants completed the task in scanner with acceptable behavioral data and fMRI data. Quality control for fMRI included visual inspection of brain images for quality, coverage, and proper alignment across functional, anatomic and template images. The fMRI images passed analysis benchmarks of \<20% censored volumes and \<0.25 mm Euclidean distance average censored motion across the task. Censor thresholds are 0.3 mm Euclidean distance and 5% voxels with outlying intensity values.
Change in Interpretation Bias
时间窗: Up to one day before and after the single 1 day training session of Interpretation bias training session.
Interpretation bias is measured by the indifference point of happy-angry judgments of a continuum of 15 images of face emotion expression that are morphed between completely happy=1 to completely angry=15 facial expressions. Indifference point is represented on this scale of 1 to 15 faces. It represents the point on the face continuum where judgements change from predominantly happy to predominantly angry. Indifference points have a minimum value of 1 and a maximum value of 15, though are typically in the middle of the face-emotion continuum, e.g. 7. Lower indifference points represent a higher bias towards hostile (or angry) judgments. Change in interpretation bias is the difference between the post- and pre-training indifference points. This can range from -14 to 14, with positive numbers reflecting the degree to which the happy/angry decision bias is shifted towards more happy judgements. High positive numbers reflect a greater increase in happy judgments.
次要结局
- Irritability(Within one week prior to Interpretation bias training and one week +/- 3 days after Interpretation bias training.)
- Learning Rate(During the course of the 1 day single interpretation bias training session.)