NCT04734171

Social Activity, Loneliness and Stigma During COVID-19 Outbreak

Completed NA Last updated 2 February 2021

What this trial tests

NA trial testing Digital social activity video intervention in Covid19 in 1,200 participants. Completed in 16 April 2020.

Timeline

2 April 2020

Primary endpoint
16 April 2020

16 April 2020

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	prevention
Enrollment	1,200
Start date	2 April 2020
Primary completion	16 April 2020
Estimated completion	16 April 2020
Sites	1 location across United States

Drugs / interventions tested

• Digital social activity video intervention
• Informational sheet
• Stigma awareness video intervention

Conditions studied

• Covid19 — all drugs for Covid19 →
• Fear — all drugs for Fear →
• Loneliness — all drugs for Loneliness →

Sponsor

Columbia University

Who can join

Adults 18 to 70, any sex, with Covid19 or Fear. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effectiveness of a Video-Based Intervention on Reducing Perceptions of Fear, Loneliness, and Public Stigma Related to COVID-19: A Randomized Controlled Trial.
   Valeri L, Amsalem D, Jankowski S, Susser E, et al · · 2021 · cited 12× · PMID 34475811 · DOI 10.3389/ijph.2021.1604164
2. COVID 19 pandemic challenges and their management: A review of medicines, vaccines, patents and clinical trials with emphasis on psychological health issues.
   Mohapatra S, Ayash Kumar P, Farooq U, Jain P, et al · · 2022 · cited 3× · PMID 35645588 · DOI 10.1016/j.jsps.2022.05.004