NCT04734171

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2020

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
Last Updated

February 2, 2021

Status Verified

February 1, 2021

Enrollment Period

14 days

First QC Date

January 29, 2021

Last Update Submit

February 1, 2021

Conditions

Covid19FearLoneliness

Keywords

Covid19 related stigma, fear and loneliness

Outcome Measures

Primary Outcomes (4)

  • 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). 1. Strongly disagree = 1 2. Disagree = 2 3. Agree = 3 4. Strongly agree = 4 5. prefer not to answer: missing value

    Baseline and 2 weeks

  • 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. 1. Not at all = 1 2. A bit = 2 3. Quite a bit = 3 4. A lot = 4 OR 1. Strongly disagree = 1 2. Disagree = 2 3. Agree = 3 4. Strongly agree = 4 5. Prefer not to answer = missing value

    Baseline and 2 weeks

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

    Baseline and 2 weeks

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

    Baseline and 2 weeks

Secondary Outcomes (2)

  • Change in time spent on internet ordinal score 2 weeks after the intervention

    Baseline and 2 weeks

  • Change in social activity ordinal score 2 weeks after the intervention

    Baseline and 2 weeks

Study Arms (4)

Informational sheet (IS)

PLACEBO COMPARATOR

participant receives an informational sheet about COVID-19

Behavioral: Informational sheet

IS + Video Solo

ACTIVE COMPARATOR

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

Behavioral: Informational sheetBehavioral: Stigma awareness video intervention

IS + Video Friends

ACTIVE COMPARATOR

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 interventionBehavioral: Informational sheet

Control

NO INTERVENTION

No intervention

Interventions

Digital social activity video interventionBEHAVIORAL

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.

IS + Video Friends
Informational sheetBEHAVIORAL

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

Also known as: Vignette
IS + Video FriendsIS + Video SoloInformational sheet (IS)
Stigma awareness video interventionBEHAVIORAL

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

IS + Video Solo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Less than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Linda Valeri, PhD

    Assistant Professor of Biostatistics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Biostatistics, Department of Biostatistics

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 2, 2021

Study Start

April 2, 2020

Primary Completion

April 16, 2020

Study Completion

April 16, 2020

Last Updated

February 2, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)