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

NCT05035550 | Completed Results DMC

• 1 other identifier: NDP00004435
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Keywords

COVID-19; Non-Deceptive Placebos; Intervention; Telehealth; Stress; Anxiety; Depression

Outcome Measures

Primary Outcomes (4)

• COVID-19 Related Stress

  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.

  COVID-19 related stress was measured at Baseline (Day 1), Midpoint (Day 7), and Endpoint (Day 14)

• Perceived Stress

  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.

  Perceived stress measured at Baseline (Day 1), Midpoint (Day 7), and Endpoint (Day 14)

• Anxiety

  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.

  Anxiety symptom severity was measured at Baseline (Day 1), Midpoint (Day 7), and Endpoint (Day 14)

• Depression

  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.

  Depression symptom severity was measured at Baseline (Day 1), Midpoint (Day 7), and Endpoint (Day 14)

Secondary Outcomes (5)

• 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).

• Intervention Feasibility

  Ratings of intervention feasibility were measured at Endpoint (Day 14)

• Intervention Acceptability

  Ratings of intervention acceptability were measured at Endpoint (Day 14)

• Intervention Appropriateness

  Ratings of intervention appropriateness were measured at Endpoint (Day 14)

Study Arms (2)

Non-Deceptive Placebo

EXPERIMENTAL

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).

Behavioral: Non-Deceptive Placebo

No-Treatment Control

NO INTERVENTION

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).

Interventions

Non-Deceptive Placebo 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.

Non-Deceptive Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michigan State University: lead

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48823, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; COVID-19

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Jason Moser
• Organization: Michigan State University

jmoser@msu.edu

517-355-2159

Study Officials

• Jason S Moser, Ph.D.

  Michigan State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The control group was blinded to their condition. The intervention group was not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: September 5, 2021
• Study Start: February 4, 2021
• Primary Completion: May 5, 2021
• Study Completion: May 5, 2021
• Last Updated: March 13, 2024
• Results First Posted: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: IPD will be available one year after publication
• Access Criteria: IPD will be available upon request.

Locations

US (1)