Social Activity, Loneliness and Stigma During COVID-19 Outbreak
Primary Purpose
Covid19, Fear, Loneliness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital social activity video intervention
Informational sheet
Stigma awareness video intervention
Sponsored by
About this trial
This is an interventional prevention trial for Covid19 focused on measuring Covid19 related stigma, fear and loneliness
Eligibility Criteria
Inclusion Criteria:
- At least 18 years old
- Younger than 70 years old
- United States resident
Exclusion Criteria:
- Less than 18 years old
Sites / Locations
- Columbia University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
No Intervention
Arm Label
Informational sheet (IS)
IS + Video Solo
IS + Video Friends
Control
Arm Description
participant receives an informational sheet about COVID-19
participants an informational sheet about COVID-19 and a 90 seconds video aimed at sensitizing participants to COVID-19 related stigma
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.
No intervention
Outcomes
Primary Outcome Measures
Change in total stigma score 2 weeks after the intervention
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).
Strongly disagree = 1
Disagree = 2
Agree = 3
Strongly agree = 4
prefer not to answer: missing value
Change in total fear score 2 weeks after the intervention
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.
Not at all = 1
A bit = 2
Quite a bit = 3
A lot = 4
OR
Strongly disagree = 1
Disagree = 2
Agree = 3
Strongly agree = 4
Prefer not to answer = missing value
Change in loneliness ordinal score 2 weeks after the intervention
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?
Not at all = 1
A bit = 2
Quite a bit = 3
A lot = 4
Change in fear of people COVID-19+ ordinal score 2 weeks after the intervention
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)?
Not at all = 1
A bit = 2
Quite a bit = 3
A lot = 4
Secondary Outcome Measures
Change in time spent on internet ordinal score 2 weeks after the intervention
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):
<1 h = 1
1h-4h = 2
4h-7h = 3
>7h = 4
Change in social activity ordinal score 2 weeks after the intervention
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)?
0-2 = 1
2-5 = 2
5-7 = 3
more than 7 = 4
Full Information
NCT ID
NCT04734171
First Posted
January 29, 2021
Last Updated
February 1, 2021
Sponsor
Columbia University
Collaborators
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT04734171
Brief Title
Social Activity, Loneliness and Stigma During COVID-19 Outbreak
Official Title
COVID-19 and Its Implications on Social Activity, Loneliness and Stigma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 2, 2020 (Actual)
Primary Completion Date
April 16, 2020 (Actual)
Study Completion Date
April 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
New York State Psychiatric Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Currently, the world is experiencing a Coronavirus outbreak, COVID-19, which originated in mainland China in December 2019, spread rapidly to South Korea and Europe, Italy in particular, between January and March of 2020 and is currently spreading in all continents and has been recognized as a pandemic. It is of high importance to monitor how the trends in COVID-19 outbreak are shaping the social contexts and norms across communities and families. In a time in which individuals all over the world are experiencing quarantine, it is important to evaluate the potential surge of the phenomena of social anxiety, stigma, and of perceived fear and loneliness. Furthermore, it is critical to study interventions that aim to reduce each of these. 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. The hypotheses will be tested using ANOVA and multinomial logistic regressions. An alpha level of 0.01 will be used to account for multiple testing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Fear, Loneliness
Keywords
Covid19 related stigma, fear and loneliness
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Informational sheet (IS)
Arm Type
Placebo Comparator
Arm Description
participant receives an informational sheet about COVID-19
Arm Title
IS + Video Solo
Arm Type
Active Comparator
Arm Description
participants an informational sheet about COVID-19 and a 90 seconds video aimed at sensitizing participants to COVID-19 related stigma
Arm Title
IS + Video Friends
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Digital social activity video intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Informational sheet
Other Intervention Name(s)
Vignette
Intervention Description
An informational sheet to learn about the COVID-19 outbreak (standard).
Intervention Type
Behavioral
Intervention Name(s)
Stigma awareness video intervention
Intervention Description
A video aimed at sensitizing participants to COVID-19 related stigma. A COVID-19 + individual share their experience.
Primary Outcome Measure Information:
Title
Change in total stigma score 2 weeks after the intervention
Description
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).
Strongly disagree = 1
Disagree = 2
Agree = 3
Strongly agree = 4
prefer not to answer: missing value
Time Frame
Baseline and 2 weeks
Title
Change in total fear score 2 weeks after the intervention
Description
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.
Not at all = 1
A bit = 2
Quite a bit = 3
A lot = 4
OR
Strongly disagree = 1
Disagree = 2
Agree = 3
Strongly agree = 4
Prefer not to answer = missing value
Time Frame
Baseline and 2 weeks
Title
Change in loneliness ordinal score 2 weeks after the intervention
Description
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?
Not at all = 1
A bit = 2
Quite a bit = 3
A lot = 4
Time Frame
Baseline and 2 weeks
Title
Change in fear of people COVID-19+ ordinal score 2 weeks after the intervention
Description
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)?
Not at all = 1
A bit = 2
Quite a bit = 3
A lot = 4
Time Frame
Baseline and 2 weeks
Secondary Outcome Measure Information:
Title
Change in time spent on internet ordinal score 2 weeks after the intervention
Description
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):
<1 h = 1
1h-4h = 2
4h-7h = 3
>7h = 4
Time Frame
Baseline and 2 weeks
Title
Change in social activity ordinal score 2 weeks after the intervention
Description
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)?
0-2 = 1
2-5 = 2
5-7 = 3
more than 7 = 4
Time Frame
Baseline and 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least 18 years old
Younger than 70 years old
United States resident
Exclusion Criteria:
Less than 18 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Valeri, PhD
Organizational Affiliation
Assistant Professor of Biostatistics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Social Activity, Loneliness and Stigma During COVID-19 Outbreak
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