Optimizing Exercise for the Treatment of Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change in Anxiety Sensitivity Index-3 (ASI-3) score
研究概览
简要总结
90 sedentary adults with a primary anxiety disorder and high anxiety sensitivity will be randomized to either 8 weeks of 1) low intensity exercise, or 2) flexible titration to high intensity exercise (HIE). Blinded, validated clinician-rated and patient-rated outcomes will be assessed over treatment and at 1- and 3-month follow-up. To better understand what mechanisms influence decisions to exercise in the real-world, we will use of heart rate (HR) as an objective mechanistic target for exercise intensity, examine changes in valuation of exercise through a neuroeconomics task, examine changes in interoceptive sensitivity with a heartbeat detection task, and integrate of ecological momentary assessment (EMA) to measure effects of immediate changes in mood with exercise on anxiety outcomes and adherence.
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
- None
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
- 否
入选标准
- •Males and females ages 18-65
- •Primary psychiatric diagnosis of generalized anxiety disorder (GAD), social anxiety disorder, or panic disorder
- •Anxiety Sensitivity Index-3 score of ≥23 (i.e., high anxiety sensitivity)
- •Currently sedentary (≤60 minutes of moderate intensity exercise per week for the past 3 months)
- •Body mass index <40
- •Able and willing to provide informed consent
排除标准
- •Lifetime history of Bipolar I or II or any psychotic disorder
- •Bulimia or anorexia in the past 6 months
- •Substance use disorder in the past 3 months
- •Current PTSD (past PTSD is allowed)
- •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
研究组 & 干预措施
Titration to high intensity exercise
干预措施: Titration to high intensity exercise (T-HIE) (Behavioral)
Low intensity exercise
干预措施: Low intensity exercise prescription (Behavioral)
结局指标
主要结局
Change in Anxiety Sensitivity Index-3 (ASI-3) score
时间窗: Baseline, Week 8
The ASI-3 is an 18-item measure of fear of anxiety sensations with three subscales (physical, cognitive, social concerns). The total score ranges from 0 (lowest anxiety sensitivity) to 72 (highest anxiety sensitivity).
Change in Clinical Global Impressions/Severity Scale score
时间窗: Baseline, Week 8
A validated Clinical Global Impressions/Severity Scale (CGI) anchored for anxiety disorders measures overall functioning and clinical improvement. CGI-S is rated from 1 (least disordered) to 7 (most disordered).Scores of 1 or 2 on the CGI-I at post-treatment will represent significant response.
次要结局
- Work and Social Adjustment Scale (WSAS) Score(Week 1, Week 4, Week 8, Week 12, Week 20)
- 7 Day Physical Activity Recall Questionnaire (PAR) Score(Weekly from Week 0 (screening) to Week 20)
- Preferences for and Tolerance of the Intensity of Exercise Questionnaire (PRETIE-Q) Score(Week 1, Week 4, Week 8, Week 12, Week 20)
- Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Score(Week 1, Week 4, Week 8, Week 12, Week 20)
- Barriers Specific-Self-Efficacy Scale (BARSE) Score(Week 1, Week 4, Week 8, Week 12, Week 20)
- Engagement(Week 12, Week 20)
- Adherence(Week 8, Week 12, Week 20)
- Multidimensional Assessment of Interoceptive Awareness (MAIA-2) Score(Week 1, Week 4, Week 8, Week 12, Week 20)
- Ecological Momentary Assessment (EMA) Score(Weekly from week 1 to week 20)
- Overall Anxiety Severity and Impairment Scale (OASIS) Score(Week 1, Week 4, Week 8, Week 12, Week 20)
- Score on Montgomery-Asberg Depression Rating Scale (MADRS)(Week 1, Week 4, Week 8, Week 12, Week 20)
- Physical Activity Enjoyment Scale (PACES)(Week 1, Week 4, Week 8, Week 12, Week 20)
- Heartrate(Weekly from week 1 to week 20)
- Neuroeconomics willingness-to-pay (WTP) auction task adapted for exercise(Week 1, Week 4, Week 8, Week 12, Week 20)
- Heartrate by Heartbeat Detection Task(Week 1, Week 4, Week 8, Week 12, Week 20)