Effects of Open-label Placebos on COVID-related Psychological Health
Purpose
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.
Conditions
- Stress
- Anxiety
- Depression
Eligibility
- Eligible Ages
- Between 18 Years and 30 Years
- Eligible Genders
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
- Masking Description
- The control group was blinded to their condition. The intervention group was not blinded.
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental 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). |
|
No Intervention 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). |
|
Recruiting Locations
More Details
- NCT ID
- NCT05035550
- Status
- Completed
- Sponsor
- Michigan State University