NCT04440098

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,008

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

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 22, 2020

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 18, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

19 days

First QC Date

June 18, 2020

Last Update Submit

June 18, 2020

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    Day 1

Study Arms (1)

Isolated Observational group

All participants socially restricted as a result of COVID-19

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • years old
  • Currently living in the United States

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DepressionAnxiety DisordersAlcoholismSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersAlcohol-Related DisordersChemically-Induced Disorders

Study Officials

  • Viviana E Horigian, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Educator Track

Study Record Dates

First Submitted

June 18, 2020

First Posted

June 19, 2020

Study Start

April 22, 2020

Primary Completion

May 11, 2020

Study Completion

May 11, 2020

Last Updated

June 19, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations