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Completed

NCT Number: NCT04440098

Isolated During COVID-19: Effects of COVID-19's Social Restrictions on Loneliness and Psychosocial Symptomatology

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).

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-35 years old
  • Currently living in the United States

Exclusion criteria

  • Those under 18 years, or older than 35 years
  • Adults unable to consent
  • Non-English-speaking adults

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 19, 2020
Registry last updated
Jun 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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