Social Activity, Loneliness and Stigma During COVID-19 Outbreak

NCT ID: NCT04734171

Last Updated: 2021-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-02

Study Completion Date

2020-04-16

Brief Summary

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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

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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.

Conditions

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Covid19 Fear Loneliness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Informational sheet (IS)

participant receives an informational sheet about COVID-19

Group Type PLACEBO_COMPARATOR

Informational sheet

Intervention Type BEHAVIORAL

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

IS + Video Solo

participants an informational sheet about COVID-19 and a 90 seconds video aimed at sensitizing participants to COVID-19 related stigma

Group Type ACTIVE_COMPARATOR

Informational sheet

Intervention Type BEHAVIORAL

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

Stigma awareness video intervention

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Digital social activity video intervention

Intervention Type 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

Intervention Type BEHAVIORAL

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

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Informational sheet

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

Intervention Type BEHAVIORAL

Stigma awareness video intervention

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Vignette

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Less than 18 years old
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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New York State Psychiatric Institute

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Linda Valeri

Assistant Professor of Biostatistics, Department of Biostatistics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Linda Valeri, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Biostatistics

Locations

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Columbia University

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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AAAT0067

Identifier Type: -

Identifier Source: org_study_id

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