LonelinessNCT04440098
Isolated During COVID-19: Effects of COVID-19's Social Restrictions on Loneliness and Psychosocial Symptomatology
An observational study of Loneliness and Depression, run by University of Miami at 1 site in United States.
Trial summary
This study seeks to gather data and insight on epidemiologic trends of loneliness and other behaviors in the wake of the CDC recommended "social distancing" during the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Loneliness, Depression, Anxiety
- How many people
- 1,008 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2020to 11 May 2020
- Phase
- Observational
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community sample
Who may be able to join
- 18-35 years old
- Currently living in the United States
Who cannot join
- Those under 18 years, or older than 35 years
- Adults unable to consent
- Non-English-speaking adults
Trial locations and contacts
1 site in 1 country.
About this study
This study seeks to gather data and insight on epidemiologic trends of loneliness and other behaviors in the wake of the CDC recommended "social distancing" during the COVID-19 pandemic. The objective of this study is to use a cross-sectional survey to assess the impact of COVID-19's associated recommendations (social distancing, self-isolation, and self-quarantine) on loneliness and psychosocial symptomatology (depression, anxiety, substance abuse) on young adults (18-35 years old).
- Conditions
- Loneliness, Depression, Anxiety, Alcohol Abuse, Drug Abuse
- Medical subject headings
- Depression, Anxiety Disorders, Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Isolated Observational group | All participants socially restricted as a result of COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness as evaluated by the UCLA loneliness scale
University of California Los Angeles ( UCLA) Loneliness Scale is a 20-item self-report questionnaire that evaluates subjective feelings of loneliness and social isolation. Participants rate items on a 4-point Likert scale ranging from 1 (never) to 4 (often).Items are summed to create a score that can range from 20-80, higher scores being indicative of greater loneliness.
Measured: Day 1
Alcohol Use as evaluated by the AUDIT
Alcohol Use Disorder Identification Test (AUDIT) is a 10-item self-reported questionnaire used to identify individuals whose alcohol consumption could be hazardous for their health. Participants rate items in a 5-point Likert scale, indicating amount (0 to 10 drinks or more), frequency (never to daily or almost daily), and indication of problems caused by alcohol (yes or no). Items were summed up to create a score that can range from 0 to 50. A score of 1 to 7 indicates low risk consumption, whereas a score of 8-15 suggests risky or hazardous drinking, a score of more than 15 is likely to indicate high-risk drinking and alcohol dependence.
Measured: Day 1
Drug Use as evaluated by the DAST-10
The Drug Abuse Screening Test (DAST-10) is a 10-item self-reported screening test that provides a quantitative index of the degree of consequences related to drug abuse. Participants rate items yes or no, positive responses corresponding to 1 point. Items are summed up to create a score that can range from 0-10. A score of 1-2 represents risky behaviors related to drugs, 3-5 represents moderate problems, 6-8 represents substantial problems, and 9-10 represents severe problems.
Measured: Day 1
Anxiety as evaluated by GAD-7
The General Anxiety Disorder Scale (GAD- 7) is a 7- item self-reported screening tool that assess presence and severity of Generalized Anxiety Disorder. Participants rated frequency of problems in a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). Items are summed up to create a score with scores of 5, 10, and 15 being the cut-off points for mild, moderate and severe anxiety, respectively.
Measured: Day 1
Depression as assessed by CES-D-10
The Center for Epidemiologic Studies Depression scale (CES-D-10) is a 10-item self-reported measure that assesses the frequency of symptoms of depression. Participants rate frequency of symptoms in a 4-point Likert scale from 0 (rare or none of the time) to 3 (most or almost all the time). Items are summed up to create a score that ranges from 0 to 30, with higher scores representing greater depressive symptoms. A score of 16 or more represents clinical depression.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start22 Apr 2020
- Primary completion11 May 2020
- Study completion11 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,008 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viviana Horigian, University of Miami
- Investigators
- Viviana E Horigian, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440098
- Sponsor's protocol ID
- 20200446
- Status last verified
- Jun 2020
- First submitted
- 18 Jun 2020
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Horigian VE, Schmidt RD, Feaster DJ. Loneliness, Mental Health, and Substance Use among US Young Adults during COVID-19. J Psychoactive Drugs. 2021 Jan-Mar;53(1):1-9. doi: 10.1080/02791072.2020.1836435. Epub 2020 Oct 28.
PubMed 33111650
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolated During COVID-19: Effects of COVID-19's Social Restrictions on Loneliness and Psychosocial Symptomatology
- ClinicalTrials.gov ID
- NCT04440098
- Acronym / sponsor ID
- 20200446
- Conditions
- Loneliness, Depression, Anxiety, Alcohol Abuse, Drug Abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,008 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 11 May 2020 (actual)
- Study completion
- 11 May 2020 (actual)
- First posted
- 19 Jun 2020 (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.
This study seeks to gather data and insight on epidemiologic trends of loneliness and other behaviors in the wake of the CDC recommended "social distancing" during the COVID-19 pandemic. The objective of this study is to use a cross-sectional survey to assess the impact of COVID-19's associated recommendations (social distancing, self-isolation, and self-quarantine) on loneliness and psychosocial symptomatology (depression, anxiety, substance abuse) on young adults (18-35 years old).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isolated Observational group | – | –All participants socially restricted as a result of COVID-19 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample
Key inclusion criteria (2 listed)
- 18-35 years old
- Currently living in the United States
Key exclusion criteria (3 listed)
- Those under 18 years, or older than 35 years
- Adults unable to consent
- Non-English-speaking adults
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Loneliness as evaluated by the UCLA loneliness scale
Time frame: Day 1
University of California Los Angeles ( UCLA) Loneliness Scale is a 20-item self-report questionnaire that evaluates subjective feelings of loneliness and social isolation. Participants rate items on a 4-point Likert scale ranging from 1 (never) to 4 (often).Items are summed to create a score that can range from 20-80, higher scores being indicative of greater loneliness.
Alcohol Use as evaluated by the AUDIT
Time frame: Day 1
Alcohol Use Disorder Identification Test (AUDIT) is a 10-item self-reported questionnaire used to identify individuals whose alcohol consumption could be hazardous for their health. Participants rate items in a 5-point Likert scale, indicating amount (0 to 10 drinks or more), frequency (never to daily or almost daily), and indication of problems caused by alcohol (yes or no). Items were summed up to create a score that can range from 0 to 50. A score of 1 to 7 indicates low risk consumption, whereas a score of 8-15 suggests risky or hazardous drinking, a score of more than 15 is likely to indicate high-risk drinking and alcohol dependence.
Drug Use as evaluated by the DAST-10
Time frame: Day 1
The Drug Abuse Screening Test (DAST-10) is a 10-item self-reported screening test that provides a quantitative index of the degree of consequences related to drug abuse. Participants rate items yes or no, positive responses corresponding to 1 point. Items are summed up to create a score that can range from 0-10. A score of 1-2 represents risky behaviors related to drugs, 3-5 represents moderate problems, 6-8 represents substantial problems, and 9-10 represents severe problems.
Anxiety as evaluated by GAD-7
Time frame: Day 1
The General Anxiety Disorder Scale (GAD- 7) is a 7- item self-reported screening tool that assess presence and severity of Generalized Anxiety Disorder. Participants rated frequency of problems in a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). Items are summed up to create a score with scores of 5, 10, and 15 being the cut-off points for mild, moderate and severe anxiety, respectively.
Depression as assessed by CES-D-10
Time frame: Day 1
The Center for Epidemiologic Studies Depression scale (CES-D-10) is a 10-item self-reported measure that assesses the frequency of symptoms of depression. Participants rate frequency of symptoms in a 4-point Likert scale from 0 (rare or none of the time) to 3 (most or almost all the time). Items are summed up to create a score that ranges from 0 to 30, with higher scores representing greater depressive symptoms. A score of 16 or more represents clinical depression.
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 19 Jun 2020.
- Derived from this study: PubMed 33111650Horigian VE, Schmidt RD, Feaster DJ. Loneliness, Mental Health, and Substance Use among US Young Adults during COVID-19. J Psychoactive Drugs. 2021 Jan-Mar;53(1):1-9. doi: 10.1080/02791072.2020.1836435. Epub 2020 Oct 28.
- 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.
Viviana E Horigian, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Loneliness and Depression, run by University of Miami 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 2 inclusion and 3 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 19 Jun 2020. 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. 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?
Loneliness as evaluated by the UCLA loneliness scale (time frame: Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04440098, which also lists 1 linked publication.
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 19 Jun 2020.