- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04734171
Social Activity, Loneliness and Stigma During COVID-19 Outbreak
COVID-19 and Its Implications on Social Activity, Loneliness and Stigma
The overall goal of this study is to evaluate the association of quarantine measures for COVID-19 and perceived anxiety, stigma and loneliness and to evaluate the efficacy of interventions in reducing anxiety, loneliness and perception of stigma induced by self-isolation during the outbreak.
Specific Aims:
In the proposed study, participants will include members of the United States general population who will be randomly assigned to either (a) a vignette to learn about the COVID-19 outbreak, (b) a vignette to learn about the COVID-19 outbreak AND a video aimed at encouraging the use of a digital device (i.e. not in person contact) to meet with friends, (c) a vignette to learn about the COVID-19 outbreak AND a video aimed at sensitizing participants to COVID-19 related stigma, (d) Control arm. Web-based self-report questionnaires will be conducted to compare interventions and control groups. The short and low-cost online module will allow recruitment of a large sample of people.
Hypotheses:
(1) the video-based intervention groups will demonstrate lower rates of anxiety and loneliness than vignette and control groups, (2) the video-based group that presents an individual with COVID-19 will demonstrate lower rate of stigma than other groups.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10025
- Columbia University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- At least 18 years old
- Younger than 70 years old
- United States resident
Exclusion Criteria:
- Less than 18 years old
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
No intervention
|
|
Placebo Comparator: Informational sheet (IS)
participant receives an informational sheet about COVID-19
|
An informational sheet to learn about the COVID-19 outbreak (standard).
Other Names:
|
Active Comparator: IS + Video Solo
participants an informational sheet about COVID-19 and a 90 seconds video aimed at sensitizing participants to COVID-19 related stigma
|
An informational sheet to learn about the COVID-19 outbreak (standard).
Other Names:
A video aimed at sensitizing participants to COVID-19 related stigma.
A COVID-19 + individual share their experience.
|
Active Comparator: IS + Video Friends
participants an informational sheet about COVID-19 and a 150 seconds video aimed at encouraging the use of a digital device (i.e.
not in person contact) to meet with friends.
|
An informational sheet to learn about the COVID-19 outbreak (standard).
Other Names:
A 150 seconds video aimed at encouraging the use of a digital device (i.e.
not in person contact) to meet with friends during the COVID-19 pandemic.
Two friends meet via zoom instead of in person and share their experiencing supporting each other.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in total stigma score 2 weeks after the intervention
Time Frame: Baseline and 2 weeks
|
This is designed to measure stigma associated with COVID-19. A continuous variable will be obtained as a sum of questionnaire items ordinal answers (4 questions, score range 4-16, 4 = low stigma, 16 = high stigma) adapted from the HIV stigma validated questionnaire (HIV stigma scale, Berger et al., 2001).
|
Baseline and 2 weeks
|
Change in total fear score 2 weeks after the intervention
Time Frame: Baseline and 2 weeks
|
This is designed to measure fear associated with COVID-19. A continuous variable will be obtained as a sum of questionnaire items (4 questions, score range 4-16, 4 = low fear, 16 = high fear) addressing fear of contracting COVID-19 and fear of consequences of COVID-19.
OR
|
Baseline and 2 weeks
|
Change in loneliness ordinal score 2 weeks after the intervention
Time Frame: Baseline and 2 weeks
|
Subjects will answer the following questionnaire item and an ordinal variable will be calculated (1 = low loneliness, 4 = high loneliness): How lonely do you feel?
|
Baseline and 2 weeks
|
Change in fear of people COVID-19+ ordinal score 2 weeks after the intervention
Time Frame: Baseline and 2 weeks
|
Ordinal variable from the questionnaire item (1 = low fear of people, 4 = high fear of people): How much are you afraid of people diagnosed with Coronavirus (COVID-19)?
|
Baseline and 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in time spent on internet ordinal score 2 weeks after the intervention
Time Frame: Baseline and 2 weeks
|
Ordinal variable from the questionnaire item time spent on the internet (for leisure or work-related activities) in the past week (averaged in number of hours)(1 = less time, 4 = more time):
|
Baseline and 2 weeks
|
Change in social activity ordinal score 2 weeks after the intervention
Time Frame: Baseline and 2 weeks
|
Ordinal variable from the questionnaire item on social contact seeking behavior in the past week (How many times did you contact [in person or via video call] your friends/family members over the last week (1 = low social activity, 4 = high social activity)?
|
Baseline and 2 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Linda Valeri, PhD, Assistant Professor of Biostatistics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAT0067
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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