Effects of Open-label Placebos Administered Through Telehealth on COVID-related Stress, Anxiety, and Depression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Michigan State University
- Enrollment
- 64
- Locations
- 2
- Primary Endpoint
- Anxiety
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
The control group was blinded to their condition. The intervention group was not blinded.
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Anxiety
Time Frame: 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
Time Frame: 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.
Perceived Stress
Time Frame: 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.
Depression
Time Frame: 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.
Secondary Outcomes
- 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).)
Investigators
Jason S. Moser
Professor of Psychology
Michigan State University