The Role of Exercise in the Consolidation of Fear Extinction Learning in Adults With High Anxiety Sensitivity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Skin Conductance Response (SCR)
研究概览
简要总结
The proposed experimental study will be the first to investigate whether exercise vs. sitting enhances consolidation of extinction learning in adults with high AS and anxiety disorders, and the mechanistic pathways of expectancy, affect, and key stress response markers.
详细描述
This is an experimental study (not a treatment study) aiming to examine the effects of acute exercise vs. sitting on fear extinction learning in a 2-day paradigm. 50 eligible (after screening) men and women ages 18-60 with high anxiety sensitivity (AS) and an anxiety disorder (generalized anxiety disorder, panic disorder, social anxiety disorder) will participate in a consecutive 2-day paradigm. Participants will be randomized to 1 of 2 conditions immediately following the emotional learning paradigm: 1) moderate intensity exercise (n=25) or 2) sitting(n=25), for 20 minutes. Day 2 will include testing of emotional learning. Primary outcomes are physiological arousal (skin conductance, heart rate) during Day 2 procedures. Mechanistic factors, including expected negative consequences of exercise, affect during exercise, threat/shock expectancy, and changes pre-post exercise in stress related neuroendocrine markers (cortisol and alpha-amylase) and their effects on extinction recall will be measured.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ages 18-60
- •A primary diagnosis of a DSM-5 anxiety disorder (generalized anxiety disorder, panic disorder, social anxiety disorder)
- •Anxiety Sensitivity Index-3 score of ≥23 (i.e., high anxiety sensitivity)
- •Able and willing to provide informed consent
排除标准
- •Lifetime Bipolar Disorder or psychosis
- •Past 3 months substance use disorder or eating disorder
- •Current PTSD (past PTSD > 6 months prior to screening is allowed)
- •High risk for exercise according to the Physical Activity Readiness Questionnaire and American College of Sports Medicine guidelines with excluded active medical conditions including heart conditions, lung disease, bone/joint problems, or seizures
- •Women who are currently pregnant
- •Acute suicide risk (active suicidal ideation with plan and intent) as indicated by a score of ≥4 on the Columbia Suicide Severity Rating Scale (C-SSRS)
- •Benzodiazepine use
- •Current substance abuse or positive urine toxicology screen (recreational use of marijuana is permitted based on clinical assessment on the MINI structured diagnostic interview that it does not meet criteria for cannabis use disorder)
- •Stable psychiatric medications for at least 4 weeks prior to experimental procedures
研究组 & 干预措施
Exercise Group
Participants who will be randomized to moderate intensity exercise after extinction (Day 1)
干预措施: Exercise (Behavioral)
Seated group
Participants who will be randomized to sitting after extinction (Day 1)
干预措施: Sitting (Behavioral)
结局指标
主要结局
Skin Conductance Response (SCR)
时间窗: Day 2 Visit
SCR will be computed for each trial by subtracting the mean skin conductance level observed during the last two seconds of context presentation from the maximal skin conductance level reached during CS presentation. All SCR values will be square-root transformed prior to any statistical analyses. To evaluate extinction recall, an extinction retention index (ERI) will be computed for each individual using the following formula: 100 - (mean SCR to the first 4 CS+E trials during recall / maximum SCR reached during conditioning for this same cue) \* 100
Heart rate (HR)
时间窗: Day 2 Visit
HR will be computed for each trial by collecting Heart rate measurements during the psychophysiological procedures.
次要结局
未报告次要终点