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Completed

NCT Number: NCT04734171

Social Activity, Loneliness and Stigma During COVID-19 Outbreak

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Fear Infections Loneliness Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University

New York, 10025, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years old
  • Younger than 70 years old
  • United States resident

Exclusion criteria

  • Less than 18 years old

Treatment and study plan

Digital social activity video intervention

Behavioral

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.

Informational Sheet

Behavioral

An informational sheet to learn about the COVID-19 outbreak (standard).

Other names: Vignette

Stigma awareness video intervention

Behavioral

A video aimed at sensitizing participants to COVID-19 related stigma. A COVID-19 + individual share their experience.

Primary outcomes

  1. 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).

    • 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

    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.

    • 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

    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?

    • 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

    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)?

    • Not at all = 1
    • A bit = 2
    • Quite a bit = 3
    • A lot = 4

Secondary outcomes

  1. 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):

    • <1 h = 1
    • 1h-4h = 2
    • 4h-7h = 3
    • >7h = 4

  2. 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)?

    • 0-2 = 1
    • 2-5 = 2
    • 5-7 = 3
    • more than 7 = 4

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • New York State Psychiatric Institute

Registry information

Official study title

COVID-19 and Its Implications on Social Activity, Loneliness and Stigma

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 2, 2021
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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