Clinical trial NCT05035550: Effects of Open-label Placebos on COVID-related Psychological Health
Official title: Effects of Open-label Placebos Administered Through Telehealth on COVID-related Stress, Anxiety, and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Anxiety
Depression
Keywords: COVID-19
Non-Deceptive Placebos
Intervention
Telehealth
Stress
Anxiety
Depression
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: COVID-19 Related Stress
timeFrame: COVID-19 related stress was measured at Baseline (Day 1), Midpoint (Day 7), and Endpoint (Day 14)
measure: Perceived Stress
timeFrame: Perceived stress measured at Baseline (Day 1), Midpoint (Day 7), and Endpoint (Day 14)
measure: Anxiety
timeFrame: Anxiety symptom severity was measured at Baseline (Day 1), Midpoint (Day 7), and Endpoint (Day 14)
measure: Depression
timeFrame: Depression symptom severity was measured at Baseline (Day 1), Midpoint (Day 7), and Endpoint (Day 14)
Secondary outcomes:
measure: Treatment Expectations
timeFrame: Treatment expectations were measured during the administration of the intervention (Day 1) and at the end of the study (Day 14)
measure: Treatment Adherence
timeFrame: Treatment adherence was measured daily for 14 days beginning after intervention administration (Day 1).
measure: Intervention Feasibility
timeFrame: Ratings of intervention feasibility were measured at Endpoint (Day 14)
measure: Intervention Acceptability
timeFrame: Ratings of intervention acceptability were measured at Endpoint (Day 14)
measure: Intervention Appropriateness
timeFrame: Ratings of intervention appropriateness were measured at Endpoint (Day 14)
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
Study officials:
affiliation: Michigan State University
name: Jason S Moser, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: