Effects of Open-label Placebos on COVID-related Psychological Health

NCT ID: NCT05035550

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-04
• Study Completion Date: 2021-05-05

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.

Conditions

Stress; Anxiety; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Non-Deceptive Placebo

Intervention Type: BEHAVIORAL

The placebos were ordered through Amazon from Zeebo® (Zeebo, Zeebo Effect, LLC, South Burlington, Vermont, USA). The placebos in this study were blue and white capsules containing Microcrystalline cellulose (an inert fiber). Ingredients include ones that are typically used to make pills including silica, gelatin, titanium dioxide, red #3 food coloring, and blue #1 food coloring. Placebo capsules were free of any active ingredients. These bottles were not branded specifically for the experiment, including the brand name ("Zeebo Relief"), description of the contents, directions, and a disclaimer. The investigators chose to not include a custom label for transparency and in order to increase "non-deceptive" placebo effects. Participants were instructed to take two pills a day, one in the morning and one in the evening.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Non-Deceptive Placebo

The placebos were ordered through Amazon from Zeebo® (Zeebo, Zeebo Effect, LLC, South Burlington, Vermont, USA). The placebos in this study were blue and white capsules containing Microcrystalline cellulose (an inert fiber). Ingredients include ones that are typically used to make pills including silica, gelatin, titanium dioxide, red #3 food coloring, and blue #1 food coloring. Placebo capsules were free of any active ingredients. These bottles were not branded specifically for the experiment, including the brand name ("Zeebo Relief"), description of the contents, directions, and a disclaimer. The investigators chose to not include a custom label for transparency and in order to increase "non-deceptive" placebo effects. Participants were instructed to take two pills a day, one in the morning and one in the evening.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Michigan State University

OTHER

Sponsor Role: lead

Responsible Party

Jason S. Moser

Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason S Moser, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Locations

Michigan State University

East Lansing, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NDP00004435

Identifier Type: -

Identifier Source: org_study_id