Effects of Open-label Placebos Administered Through Telehealth on COVID-related Stress, Anxiety, and Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Perceived Stress
研究概览
简要总结
This project aimed to test the efficacy of a telehealth-administered placebo without deception intervention on stress, anxiety, and depression related to the COVID-19 pandemic. Participants were randomized into two groups (open-label placebo vs. no-treatment control). All participants received information on the impact of COVID-19 on psychological health. Participants in the open-label placebo group were instructed to watch an informational video on the beneficial effects of placebos without deception, remotely interact with an experimenter, and take open-label placebo pills twice a day for two weeks. Participants in the no-treatment control group did not receive any intervention. Instead, participants met with an experimenter and reported on their psychological and physical health. The investigators predicted that the placebo without deception group would exhibit substantially reduced stress, depression, and anxiety compared to a no-treatment control group.
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
- Single (Participant)
盲法说明
The control group was blinded to their condition. The intervention group was not blinded.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals who have experienced moderate COVID-19 stress, as assessed by a score of ≥ 35 on the COVID-19 Stress Scale (Taylor et al., 2020).
排除标准
- •Non-Michigan residents; self-reported diagnosis of anxiety, depression, ADHD, schizophrenia, bipolar disorder, substance use disorder; currently taking psychotropic medication including antidepressants, anti-anxiety medication or stimulants; allergies or concerns with the placebo pill ingredients; or active diagnosis of COVID-19 at the time of eligibility or enrollment.
研究组 & 干预措施
Non-Deceptive Placebo
The NDP group was informed that the purpose of the study was to test a mind-body intervention that might help participants deal with the stress and anxiety that they are feeling during the pandemic. The intervention included two videos that introduced the effects of non-deceptive placebos, followed by a presentation on up-to-date non-deceptive placebo research. The participants then received instruction on how they would take their non-deceptive placebos for the next two weeks. Participants were asked to complete daily pill-taking adherence surveys (~5 min) and weekly at midpoint (1-week) and endpoint (2-week).
干预措施: Non-Deceptive Placebo (Behavioral)
No-Treatment Control
The Control group did not receive an intervention. Instead, participants were informed that the purpose of the study was to track individual psychological and physical health over longer time periods in the context of the pandemic. Participants were asked to complete weekly questionnaires at midpoint (1-week) and endpoint (2-week).
结局指标
主要结局
Perceived Stress
时间窗: Perceived stress measured at Baseline (Day 1), Midpoint (Day 7), and Endpoint (Day 14)
Self-reported perceived stress was measured using the Perceived Stress Scale (PSS). The Perceived Stress Scale (PSS) is a 10-item self-report questionnaire that assesses the extent to which different situations affect our perceptions of stress during the last month (Cohen, 1994). The scale was modified for the current study in order to measure ratings of perceived stress over the past 7 days. Participants rated each item on a 0 (never) to 4 (very often) scale. Total score ranges from 0-40 with higher scores indicating greater perceived stress.
Anxiety
时间窗: Anxiety symptom severity was measured at Baseline (Day 1), Midpoint (Day 7), and Endpoint (Day 14)
Self-reported anxiety was measured using the PROMIS Emotional Distress - Anxiety - Short Form. The PROMIS Emotional Distress - Anxiety - Short Form is an 8-item self-report questionnaire that assesses anxiety over the past 7 days in adults. Participants rated each item on a 1 (never) to 4 (always) scale. Total score ranges from 8-40 with higher scores indicating greater anxiety.
COVID-19 Related Stress
时间窗: COVID-19 related stress was measured at Baseline (Day 1), Midpoint (Day 7), and Endpoint (Day 14)
Self-reported COVID-19 related stress was measured using the COVID-19 Stress Scale. The Covid stress scale (CSS) is a 36-item self-report questionnaire that measures stress-related to COVID-19 (Taylor et al., 2020). Participants rated each item on a 0 (not at all) to 4 (extremely) scale. For the purposes of this study, only total scores were calculated. Total score ranges from 0-144 with higher scores indicating greater COVID-related stress.
Depression
时间窗: Depression symptom severity was measured at Baseline (Day 1), Midpoint (Day 7), and Endpoint (Day 14)
Self-reported anxiety was measured using the Center for Epidemiological Studies - Depression (CES-D) Scale. The Center for Epidemiological Studies - Depression (CES-D) Scale is a 20-item self-report questionnaire that assesses depressive symptoms over the past 7 days. Participants rated each item on a 0 \[rarely or none at the time (less than one day)\] to 3 \[most or all of the time (5 to 7 days)\] scale. Total score ranges from 0-60 with higher scores indicating higher levels of depression.
次要结局
- Intervention Acceptability(Ratings of intervention acceptability were measured at Endpoint (Day 14))
- Intervention Feasibility(Ratings of intervention feasibility were measured at Endpoint (Day 14))
- Intervention Appropriateness(Ratings of intervention appropriateness were measured at Endpoint (Day 14))
- Treatment Expectations(Treatment expectations were measured during the administration of the intervention (Day 1) and at the end of the study (Day 14))
- Treatment Adherence(Treatment adherence was measured daily for 14 days beginning after intervention administration (Day 1).)
研究者
Jason S. Moser
Professor of Psychology
Michigan State University