Social Activity, Loneliness and Stigma During COVID-19 Outbreak

Sponsor
Columbia University (Other)
Overall Status
Completed
CT.gov ID
NCT04734171
Collaborator
New York State Psychiatric Institute (Other)
1,200
1
4
14
2608.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Digital social activity video intervention
  • Behavioral: Informational sheet
  • Behavioral: Stigma awareness video intervention
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1200 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
COVID-19 and Its Implications on Social Activity, Loneliness and Stigma
Actual Study Start Date :
Apr 2, 2020
Actual Primary Completion Date :
Apr 16, 2020
Actual Study Completion Date :
Apr 16, 2020

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Informational sheet (IS)

participant receives an informational sheet about COVID-19

Behavioral: Informational sheet
An informational sheet to learn about the COVID-19 outbreak (standard).
Other Names:
  • Vignette
  • 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

    Behavioral: Informational sheet
    An informational sheet to learn about the COVID-19 outbreak (standard).
    Other Names:
  • Vignette
  • Behavioral: Stigma awareness video intervention
    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.

    Behavioral: Digital social activity video intervention
    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.

    Behavioral: Informational sheet
    An informational sheet to learn about the COVID-19 outbreak (standard).
    Other Names:
  • Vignette
  • No Intervention: Control

    No intervention

    Outcome Measures

    Primary Outcome Measures

    1. Change in total stigma score 2 weeks after the intervention [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). Strongly disagree = 1 Disagree = 2 Agree = 3 Strongly agree = 4 prefer not to answer: missing value

    2. Change in total fear score 2 weeks after the intervention [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. 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

    3. Change in loneliness ordinal score 2 weeks after the intervention [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? Not at all = 1 A bit = 2 Quite a bit = 3 A lot = 4

    4. Change in fear of people COVID-19+ ordinal score 2 weeks after the intervention [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)? Not at all = 1 A bit = 2 Quite a bit = 3 A lot = 4

    Secondary Outcome Measures

    1. Change in time spent on internet ordinal score 2 weeks after the intervention [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): <1 h = 1 1h-4h = 2 4h-7h = 3 >7h = 4

    2. Change in social activity ordinal score 2 weeks after the intervention [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)? 0-2 = 1 2-5 = 2 5-7 = 3 more than 7 = 4

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • At least 18 years old

    • Younger than 70 years old

    • United States resident

    Exclusion Criteria:
    • Less than 18 years old

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Columbia University New York New York United States 10025

    Sponsors and Collaborators

    • Columbia University
    • New York State Psychiatric Institute

    Investigators

    • Principal Investigator: Linda Valeri, PhD, Assistant Professor of Biostatistics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Linda Valeri, Assistant Professor of Biostatistics, Department of Biostatistics, Columbia University
    ClinicalTrials.gov Identifier:
    NCT04734171
    Other Study ID Numbers:
    • AAAT0067
    First Posted:
    Feb 2, 2021
    Last Update Posted:
    Feb 2, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Linda Valeri, Assistant Professor of Biostatistics, Department of Biostatistics, Columbia University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 2, 2021