StressNCT05035550
Effects of Open-label Placebos on COVID-related Psychological Health
A study of Stress and Anxiety, run by Michigan State University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Anxiety, Depression
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2021to 5 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan State University
East Lansing, Michigan, 48823
About this study
Official title: Effects of Open-label Placebos Administered Through Telehealth on COVID-related Stress, Anxiety, and Depression
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
- Being tested
- Non-Deceptive Placebo
- Keywords
- COVID-19, Non-Deceptive Placebos, Intervention, Telehealth, Stress, Anxiety, Depression
- Medical subject headings
- Anxiety Disorders, Depression, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Deceptive PlaceboBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Depression symptom severity was measured at Baseline (Day 1), Midpoint (Day 7), and Endpoint (Day 14)
Secondary outcomes (5)
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.
Measured: Treatment expectations were measured during the administration of the intervention (Day 1) and at the end of the study (Day 14)
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).
Measured: Treatment adherence was measured daily for 14 days beginning after intervention administration (Day 1).
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.
Measured: Ratings of intervention feasibility were measured at Endpoint (Day 14)
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.
Measured: Ratings of intervention acceptability were measured at Endpoint (Day 14)
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.
Measured: Ratings of intervention appropriateness were measured at Endpoint (Day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start4 Feb 2021
- Primary completion5 May 2021
- Study completion5 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason S. Moser, Michigan State University
- Investigators
- Jason S Moser, Ph.D., Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035550
- Sponsor's protocol ID
- NDP00004435
- Status last verified
- Mar 2024
- First submitted
- 12 Aug 2021
- Last updated
- 13 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators plan to share the IPD used in the analysis for manuscript submission.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Open-label Placebos Administered Through Telehealth on COVID-related Stress, Anxiety, and Depression
- ClinicalTrials.gov ID
- NCT05035550
- Acronym / sponsor ID
- NDP00004435
- Conditions
- Stress, Anxiety, Depression
- Keywords
- COVID-19, Non-Deceptive Placebos, Intervention, Telehealth, Stress, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 5 May 2021 (actual)
- Study completion
- 5 May 2021 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Posted 13 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Deceptive Placebo | Experimental | Behavioral: Non-Deceptive PlaceboThe 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-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). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Deceptive PlaceboThe 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. | Behavioural | Non-Deceptive Placebo |
Primary outcome
COVID-19 Related Stress
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.
Perceived 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.
Anxiety
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.
Depression
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.
5 secondary outcomes
Treatment Expectations
Time frame: Treatment expectations were measured during the administration of the intervention (Day 1) and at the end of the study (Day 14)
Treatment Adherence
Time frame: Treatment adherence was measured daily for 14 days beginning after intervention administration (Day 1).
Intervention Feasibility
Time frame: Ratings of intervention feasibility were measured at Endpoint (Day 14)
Intervention Acceptability
Time frame: Ratings of intervention acceptability were measured at Endpoint (Day 14)
Intervention Appropriateness
Time frame: Ratings of intervention appropriateness were measured at Endpoint (Day 14)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The investigators plan to share the IPD used in the analysis for manuscript submission.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason S Moser, Ph.D. principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Stress and Anxiety, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 Related Stress (time frame: COVID-19 related stress was measured at Baseline (Day 1), Midpoint (Day 7), and Endpoint (Day 14)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.