Examining Novel Biomarkers of Neuroplasticity Associated With Exercise in Adults With Anxiety Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Acetyl-L-carnitine (LAC) Levels
研究概览
简要总结
The overarching objective is to examine the brain-based biological mechanistic pathway by which exercise exerts anxiolytic effects. The investigators will measure brain-derived markers of mitochondrial metabolism (acetyl-L-carnitine [LAC]) and inflammation (interleukin-6 [IL-6]) using innovative technology to isolate neuronal exosomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For both participant groups: To be eligible to participate in this study, an individual must meet all of the following criteria:
- •Between 18-50 years of age
- •Currently sedentary (≤60 minutes of moderate intensity exercise per week for the past 3 months)
- •Capable and willing to provide informed consent
- •For anxiety disorder participant group, an individual must also meet:
- •Primary psychiatric diagnosis of generalized anxiety disorder (GAD), social anxiety disorder, or panic disorder
排除标准
- •Lifetime history of Bipolar I or II or any psychotic disorder
- •Bulimia or anorexia in the past 3 months
- •Alcohol or substance use disorder in the past 3 months
- •Current major depressive disorder (past is allowed)
- •Current neurologic disorder
- •High current 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) consistent with a need for referral to higher level of care
- •Participation in concurrent evidence-based therapy (e.g., cognitive behavioral therapy) targeting anxiety and/or depression (supportive therapy and couples therapy are allowed)
- •Risk for exercise according to the Physical Activity Readiness Questionnaire with excluded active medical conditions including heart conditions, lung disease, bone/joint problems, or seizures
- •Women who are currently pregnant or plan to become pregnant during the duration of the study
- •current psychiatric medication
- •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)
- •Active infection
- •Non-psychiatric controls who meet the following criteria will be excluded from participation in this study:
- •Current psychiatric condition assessed by the MINI
研究组 & 干预措施
Individuals with Anxiety Disorder
All participants will complete the 4-week exercise intervention in which they'll be prescribed 150 minutes of moderate intensity exercise per week at home, which will be measured using Fitbits.
干预措施: Exercise Intervention (Behavioral)
Control Individuals
All participants will complete the 4-week exercise intervention in which they'll be prescribed 150 minutes of moderate intensity exercise per week at home, which will be measured using Fitbits.
干预措施: Exercise Intervention (Behavioral)
结局指标
主要结局
Acetyl-L-carnitine (LAC) Levels
时间窗: Week 4
Levels of LAC isolated from neuronal exosomes from plasma blood draws.
Interleukin-6 (IL-6) Levels
时间窗: Week 4
Levels of IL-6 isolated from neuronal exosomes from plasma blood draws.
次要结局
- Continuously measured moderate/vigorous minutes of exercise(Up to Week 4)
- 7-Day Physical Activity Recall(Baseline, Week 2, Week 4)
- Overall Anxiety Severity and Impairment Scale (OASIS)(Baseline, Week 2, Week 4)
- Anxiety Sensitivity Index (ASI-3) Score(Baseline, Week 2, Week 4)
- Quick Inventory of Depressive Symptomatology (QIDS) Score(Baseline, Week 2, Week 4)
- Perceived Stress Scale (PSS) Score(Baseline, Week 2, Week 4)
- Childhood Trauma Questionnaire(Baseline, Week 2, Week 4)
- Insomnia Severity Index (ISI) Score(Baseline, Week 2, Week 4)
- International Physical Activity Questionnaire (IPAQ) Score(Baseline, Week 2, Week 4)
- Body Mass Index (BMI)(Baseline, Week 2, Week 4)