Michigan State University
East Lansing, Michigan, 48823, United States
NCT Number: NCT05035550
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.
Looking for future studies?
Notify Me18 year–30 year
All sexes
Interventional
Not applicable
East Lansing, Michigan, 48823, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: COVID-19 related stress was measured at Baseline (Day 1), Midpoint (Day 7), and Endpoint (Day 14)
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.
Time frame: Perceived stress measured at Baseline (Day 1), Midpoint (Day 7), and Endpoint (Day 14)
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.
Time frame: Anxiety symptom severity was measured at Baseline (Day 1), Midpoint (Day 7), and Endpoint (Day 14)
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.
Time frame: Depression symptom severity was measured at Baseline (Day 1), Midpoint (Day 7), and Endpoint (Day 14)
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.
Time frame: Treatment expectations were measured during the administration of the intervention (Day 1) and at the end of the study (Day 14)
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.
Time frame: Treatment adherence was measured daily for 14 days beginning after intervention administration (Day 1).
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).
Time frame: Ratings of intervention feasibility were measured at Endpoint (Day 14)
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.
Time frame: Ratings of intervention acceptability were measured at Endpoint (Day 14)
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.
Time frame: Ratings of intervention appropriateness were measured at Endpoint (Day 14)
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.
Michigan State University
Other
Effects of Open-label Placebos Administered Through Telehealth on COVID-related Stress, Anxiety, and Depression
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04397835
Anxiety, Anxiety Disorders
Toulouse, Occitanie, France
View Trial DetailsNCT04367363
Anxiety, Anxiety Disorders
Singapore
View Trial DetailsNCT04397848
Anxiety, Anxiety Disorders
Toronto, Ontario, Canada
View Trial DetailsNCT04305574
Anxiety, Anxiety Disorders
Singapore
View Trial Details