N/A
Completed N=64
Effects of Open-label Placebos on COVID-related Psychological Health
Source: ClinicalTrials.gov NCT05035550 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: COVID-19 Related Stress — 34.93; 35.13; 26.24; 32.37 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY COVID-19 Related Stress |
34.93; 35.13; 26.24; 32.37; 12.28; 28.34 | — |
| PRIMARY Perceived Stress |
22.52; 20.34; 17.24; 17.98; 15.00; 17.78 | — |
| PRIMARY Anxiety |
25.62; 23.69; 22.07; 22.19; 19.00; 21.81 | — |
| PRIMARY Depression |
22.69; 20.75; 17.90; 20.76; 12.93; 18.31 | — |
| SECONDARY Treatment Expectations |
6.30; 5.21; .53; .32 | — |
| SECONDARY Treatment Adherence |
92.5 | — |
| SECONDARY Intervention Feasibility |
4.31 | — |
| SECONDARY Intervention Acceptability |
4.03 | — |
| SECONDARY Intervention Appropriateness |
3.98 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05035550). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.