Inflammation and Daily Life Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Loneliness
研究概览
简要总结
UCLA researchers looking for healthy individuals (age 45-60) to participate in a study investigating whether an anti-inflammatory medication can impact daily life experiences.
Everyday for two weeks, participants will take either an anti-inflammatory medication (naproxen) twice daily, or a placebo pill twice daily. Participants will also answer daily questions during the 2-week period. Participants will also fill out questionnaires and complete a few tasks on the computer: once prior to the 2-week period and once immediately after the 2-week period, both during online study sessions.
详细描述
Participants (ntotal=50) will be men and women, ages 45-60. All interested participants will first complete a structured telephone interview in order to assess eligibility.
The study will begin with filling out questionnaires, as well as an online session to complete some tasks. You will then be randomly assigned to take either an anti-inflammatory medication (naproxen) or placebo (inactive substance) to take twice daily everyday for the following two weeks. You will also be contacted by text message to remind you to take your pills, to ask if you have taken your pills, and to send you a link to fill out questionnaires once daily. After the two weeks are over, you will again complete questionnaires and the online study session with tasks. Finally, two weeks after the second session, you will receive an email to fill out questionnaires online.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy adults 45-60
排除标准
- •Following a structured telephone interview, participants with the following conditions will not be able to participate:
- •certain active, uncontrolled medical disorders
- •use of certain medications (e.g., hypnotic and psychotropic medication, steroid use, opioid use)
- •psychiatric disorders (e.g., current major depression, bipolar disorder)
- •Other exclusion criteria may apply.
研究组 & 干预措施
Naproxen
干预措施: Naproxen (Drug)
Placebo
干预措施: Placebos (Drug)
结局指标
主要结局
Loneliness
时间窗: T1: Baseline, T2: post-intervention (2 weeks later)
Changes in self-report measures of loneliness (University of California, Los Angeles (UCLA) Loneliness Scale) Scale ranges from 20-80 (though participants were included based on higher levels of loneliness, \> 41). Higher values represent higher levels of loneliness.
Negative Picture Viewing Task
时间窗: T1: Baseline, T2: post-intervention (2 weeks later)
Changes in ratings of negative pictures "To what extent is this picture positive or negative: from -5 (very negative) to +5 (very positive)" Lower scores indicate more negativity
Social Reward Task
时间窗: T1: Baseline, T2: post-intervention (2 weeks later)
Changes in reaction time to close others vs. control image (measures in seconds) Faster reaction times indicate greater sensitivity; so lower scores (fewer seconds) indicate greater sensitivity to close others vs. control images
次要结局
- Inflammatory Gene Expression(T1: Baseline, T2: post-intervention (2 weeks later))
- Loneliness at Follow-up (2 Weeks Post-intervention)(T3: 2 weeks after the end of the intervention (4 weeks after the start of the intervention))
研究者
Naomi Eisenberger
Professor
University of California, Los Angeles