Computational Modeling of Ambiguity Aversion in Internalizing Disorders: Neural and Behavioral Markers, and a Test of Target Engagement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Beck Hopelessness Scale-4 (BHS-4)
研究概览
简要总结
The present work aims to test whether a single session intervention alters ambiguity aversion, both in terms of people's decision making and their brain responses to ambiguous choices.
详细描述
In this trial, participants will be randomized to one of two single session interventions (SSI). They will complete a decision making task before and after the SSI to measure their behavioral and brain responses to ambiguity, all on the same day. They will also complete a brief measure of hopelessness before and after the SSI. The main analysis will compare changes in ambiguity aversion before and after the interventions. Participants will also be asked to complete questionnaires before completing the task and SSI. The questionnaires will be about the participant's emotions and symptoms of depression and anxiety, personality, and avoidance/tolerance of uncertainty.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants will be aware that there is one other arm of the study to which other participants are randomized, but they will not be aware of what this other arm entails. Additionally, the intervention will be administered digitally, without a care provider, and outcome measures will be self-administered, so there is no potential for evaluator bias.
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 25 to 60
- •Right-handed
- •Ability to read and write English
- •Capacity to provide informed consent
- •Intolerance of uncertainty score ≥ -0.5 standard deviation below the mean (31st percentile)
排除标准
- •Personal history of psychosis, mania, or hypomania
- •Personal history of autism spectrum disorder
- •IQ < 80 as determined by the Wechsler Test of Adult Reading
- •Head injury with greater than 120 seconds loss of consciousness
- •Neurological condition (e.g., epilepsy, Parkinson's, cerebral palsy, history of stroke)
- •Currently pregnant
- •Use of any implanted electrical device (e.g., pacemaker, spinal stimulator, vagal nerve stimulator, Inspire sleep apnea device, etc.).
研究组 & 干预措施
Uncertainty-focused single session intervention
This is a digital, self-guided SSI that teaches adults about tolerating and embracing uncertainty in their life. The SSI is based on five elements: 1. An introduction the concept of neuroplasticity; 2. Testimonials from peers describing beliefs that people's thoughts, feelings, and behaviors are malleable, given the brain's capacity for change; 3. Strategies (from cognitive-behavioral therapy) for applying these principles to participants' lives; 4. Further vignettes by peers describing times when they tolerated or embraced uncertainty; 5. An exercise wherein participants provide advice to fictional peers, using newly-gleaned information about uncertainty,
干预措施: Uncertainty-focused single session intervention (Behavioral)
Maintaining a healthy lifestyle single session intervention
This is a digital, self-guided SSI that teaches adults about the benefits of maintaining a healthy lifestyle (e.g., proper sleep, diet, exercise), emphasizing recommendations by various bodies (e.g., American Medical Association). It is structurally similar to the uncertainty-focused SSI but is designed to mimic what people would receive in their annual physical with a primary care physician. The goals of this intervention is to encourage participants to identify aspects of a healthy lifestyle, and steps they could take towards a healthier lifestyle. This SSI is designed to control for nonspecific aspects of intervention, including engagement in a computer program, reading and writing exercises, and vignettes from peers.
干预措施: Maintaining a healthy lifestyle single session intervention (Behavioral)
结局指标
主要结局
Beck Hopelessness Scale-4 (BHS-4)
时间窗: 1 hour
The BHS-482 is a four-item self-report scale that will be used to assess hopelessness before and after the experimental intervention (scale assesses hopelessness "right now, in this moment") to determine whether the intervention was effective in eliciting change in a clinically meaningful construct. It has good psychometric properties. Participants will complete the Beck Hopelessness Scale (BHS-4) before and after the intervention as a manipulation check that the single session intervention (SSI) "worked" in the event that the other primary outcomes exhibit resistance to change.
Behavioral ambiguity aversion
时间窗: 1 hour
Computational modeling will be used to extract two parameters indicative of behavioral ambiguity aversion (AA) from a risk and ambiguity task completed once before and once after the intervention. This results in two variables per participant: one which indicates categorical AA (i.e., their tendency to choose the unambiguous choice regardless of the amount of ambiguity present) and one which indicates continuous AA (i.e., how the amount of ambiguity influences people's choice).
Event-related potential responses to ambiguous choices
时间窗: 1 hour
From EEG data collected during the risk and ambiguity task, event-related potentials (ERPs)-time-locked electroencephalogram signals with millisecond resolution-will be extracted to yield one variable per participant indicating mean brain activity to ambiguous choices. Pilot data and small prior studies have consistently found an attenuated P300-like component (albeit later than usual, around 350-500ms) to ambiguous relative to unambiguous choices similar to those on this task.
次要结局
未报告次要终点
研究者
Brent Rappaport
Assistant Professor
Northwestern University