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

Depression Clinical Trial

Official title:

Effects of Open-label Placebos Administered Through Telehealth on COVID-related Stress, Anxiety, and Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05035550
• Other study ID #: NDP00004435
• Status: Completed
• Phase: N/A
• Start date: February 4, 2021
• Est. completion date: May 5, 2021

Study information

• Verified date: March 2024
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 5, 2021
• Est. primary completion date: May 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder
• Stress

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Michigan State University	East Lansing	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Michigan State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	Treatment Expectations	Participants in the open-label placebo group rated their expectations of the open-label placebo treatment using representative questions (10-items) from each sub-scale of the Treatment Expectations Questionnaire (TEX-Q; Alberts et al. (2020). Two subscales were calculated from exploratory factor analysis: Expected benefits and Expected harm. The range for expected benefits ranged from 0-10 with higher scores indicating greater benefits from the OLP. The range for expected harm also ranged from 0-10 with higher scores indicating expecting more harm.	Treatment expectations were measured during the administration of the intervention (Day 1) and at the end of the study (Day 14)
Secondary	Treatment Adherence	Participants in the open-label placebo group were instructed to take two placebo pills a day for 14 days (28 placebo pills). Treatment adherence was measured as the percentage of placebo pills taken by each participant (number of pills taken / 28 * 100).	Treatment adherence was measured daily for 14 days beginning after intervention administration (Day 1).
Secondary	Intervention Feasibility	Intervention feasibility was measured using the Feasibility of Intervention Measure (FIM; Weiner et al., 2017). The FIM is a 4-item self-report measure that assesses the extent to which an intervention can be successfully implemented within a given setting. The items are averaged with scores ranging from 1-5 with higher numbers indicating that the OLP intervention is easy to use and doable.	Ratings of intervention feasibility were measured at Endpoint (Day 14)
Secondary	Intervention Acceptability	Intervention acceptability was measured using the Acceptability of Intervention Measure (AIM; Weiner et al., 2017). The AIM is a 4-item self-report measure that assesses the extent to which an intervention is perceived to be satisfactory, adequate, and appealing. The items are averaged with scores ranging from 1-5 with higher numbers indicating that the OLP intervention is satisfactory and appealing.	Ratings of intervention acceptability were measured at Endpoint (Day 14)
Secondary	Intervention Appropriateness	Intervention appropriateness was measured using the Intervention Appropriateness Measure (IAM; Weiner et al., 2017). The IAM is a 4-item self-report measure that assesses the extent to which an intervention is perceived to be fitting, relevant, and compatible with a population or setting to address a particular problem. The items are averaged with scores ranging from 1-5 with higher numbers indicating that the OLP intervention is perceived to be fitting, relevant, and compatible with a population or setting to address a particular problem.	Ratings of intervention appropriateness were measured at Endpoint (Day 14)