Covid19NCT04734171
Social Activity, Loneliness and Stigma During COVID-19 Outbreak
A study testing Digital social activity video intervention, Informational sheet and Stigma awareness video intervention in people with Covid19 and Fear, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, Fear, Loneliness
- What is being tested?
- Digital social activity video intervention, Informational sheet and Stigma awareness video intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2020to 16 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Younger than 70 years old
- United States resident
Who cannot join
- Less than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 and Its Implications on Social Activity, Loneliness and Stigma
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:
Read more
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.
Read the 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.
- Conditions
- Covid19, Fear, Loneliness
- Being tested
- Digital social activity video intervention, Informational sheet, Stigma awareness video intervention
- Keywords
- Covid19 related stigma, fear and loneliness
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital social activity video interventionBehavioural
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 sheetBehavioural
Also called Vignette
An informational sheet to learn about the COVID-19 outbreak (standard).
Stigma awareness video interventionBehavioural
A video aimed at sensitizing participants to COVID-19 related stigma. A COVID-19 + individual share their experience.
| Study group | Role | What they receive |
|---|---|---|
| Informational sheet (IS) | Placebo comparator | participant receives an informational sheet about COVID-19 Receives: 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 Receives: Behavioral: Informational sheet; Behavioral: 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. Receives: Behavioral: Digital social activity video intervention; Behavioral: Informational sheet |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
- Strongly disagree = 1
- Disagree = 2
- Agree = 3
- Strongly agree = 4
- prefer not to answer: missing value
Measured: 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.
- 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
Measured: 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?
- Not at all = 1
- A bit = 2
- Quite a bit = 3
- A lot = 4
Measured: 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)?
- Not at all = 1
- A bit = 2
- Quite a bit = 3
- A lot = 4
Measured: Baseline and 2 weeks
Secondary outcomes (2)
Change in time spent on internet ordinal score 2 weeks after the intervention
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
Measured: Baseline and 2 weeks
Change in social activity ordinal score 2 weeks after the intervention
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
Measured: Baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start2 Apr 2020
- Primary completion16 Apr 2020
- Study completion16 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- New York State Psychiatric Institute
- Responsible party
- Principal investigator, Linda Valeri, Columbia University
- Investigators
- Linda Valeri, PhD, Principal investigator, Assistant Professor of Biostatistics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734171
- Sponsor's protocol ID
- AAAT0067
- Status last verified
- Feb 2021
- First submitted
- 29 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 and Its Implications on Social Activity, Loneliness and Stigma
- ClinicalTrials.gov ID
- NCT04734171
- Acronym / sponsor ID
- AAAT0067
- Conditions
- Covid19, Fear, Loneliness
- Keywords
- Covid19 related stigma, fear and loneliness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- New York State Psychiatric Institute
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 16 Apr 2020 (actual)
- Study completion
- 16 Apr 2020 (actual)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Informational sheet (IS) | Placebo comparator | Behavioral: Informational sheetparticipant receives an informational sheet about COVID-19 |
| IS + Video Solo | Active comparator | Behavioral: Informational sheet, Behavioral: Stigma awareness video interventionparticipants an informational sheet about COVID-19 and a 90 seconds video aimed at sensitizing participants to COVID-19 related stigma |
| IS + Video Friends | Active comparator | Behavioral: Digital social activity video intervention, Behavioral: Informational sheetparticipants 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. |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years old
- Younger than 70 years old
- United States resident
Key exclusion criteria (1 listed)
- Less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital social activity video interventionA 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. | Behavioural | IS + Video Friends |
| Informational sheetAlso: VignetteAn informational sheet to learn about the COVID-19 outbreak (standard). | Behavioural | IS + Video Friends, IS + Video Solo, Informational sheet (IS) |
| Stigma awareness video interventionA video aimed at sensitizing participants to COVID-19 related stigma. A COVID-19 + individual share their experience. | Behavioural | IS + Video Solo |
Primary outcome
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). 1. Strongly disagree = 1 2. Disagree = 2 3. Agree = 3 4. Strongly agree = 4 5. prefer not to answer: missing value
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. 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
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? 1. Not at all = 1 2. A bit = 2 3. Quite a bit = 3 4. A lot = 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)? 1. Not at all = 1 2. A bit = 2 3. Quite a bit = 3 4. A lot = 4
2 secondary outcomes
Change in time spent on internet ordinal score 2 weeks after the intervention
Time frame: Baseline and 2 weeks
Change in social activity ordinal score 2 weeks after the intervention
Time frame: Baseline and 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Valeri, PhD principal investigator
Assistant Professor of Biostatistics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital social activity video intervention, Informational sheet and Stigma awareness video intervention in people with Covid19 and Fear, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total stigma score 2 weeks after the intervention (time frame: Baseline and 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.