COVID-19 Pandemic Impact on Alcohol (PIA) - A Natural History Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
About this trial
Background:
The SARS-CoV-2 virus has caused a pandemic infection called COVID-19. It is a global threat to people, communities, and health systems. Researchers are concerned about the mental health effects of the pandemic. They want to learn more about how it is affecting people s alcohol use and problems, and how it may continue to affect them over time.
Objective:
To study the impact of the COVID-19 pandemic on alcohol use and consequences in individuals across the spectrum of alcohol use and those with alcohol use disorder.
Eligibility:
Participants who have been screened under the NIAAA Screening, Assessment and Management Protocol (14-AA-0181)
Design:
Participants will complete a baseline survey by phone. It will ask about alcohol use, alcohol dependence, and stress. It covers 2 time periods: the 12 months before the pandemic started and the time since it started.
Participants will get an ID code and a link to an online survey. They will complete the online survey within a week of the phone survey.
Participants will complete a series of online surveys over 24 months. For the first year, surveys will be completed weekly for the first 4 weeks, then biweekly for the next 8 weeks, and then every 1-2 months for the rest of the year. For the second year, surveys will be completed every 6 months. Surveys will cover the following topics:
* Alcohol use and its consequences * Other substance use * Stress * Impact of the COVID-19 pandemic * Pain * Physical health * Sleep * Quality of life.
Because the course of the pandemic may change, the frequency of the surveys may change.
Participation lasts 2 years.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants who have enrolled in the NIAAA Natural History Protocol (14-AA-0181) and completed screening and phenotyping assessments.
Willing and able to complete frequent (weekly to monthly) surveys either online or by phone.
Disqualifiers
None
Trial population
The target population for this study includes healthy adults across the spectrum of alcohol use who have been screened under the NIAAA screening protocol (14-AA-0181). This sample includes non-drinkers, light drinkers, non-treatment-seeking heavy drinkers, and treatment-seeking individuals with alcohol use disorder.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,500 Participants
are grouped into 1 trial groupGroup A: Study Participants
Trial outcomes
Primary outcomes
1
AUDIT Score
Alcohol Use Disorder Identification Test (AUDIT): This is a 10-item questionnaire designed to screen for AUD. The first 3 questions constitute the AUDIT-C and provides a measure of alcohol consumption. The total score provides a continuous quantification of AUD severity.
Time frame
24 months2
ADS Score
Alcohol Dependence Scale (ADS): This 25-item scale will be used to measure severity of alcohol dependence. This scale covers alcohol withdrawal symptoms, impaired control over drinking, awareness of a compulsion to drink, increased tolerance to alcohol, and salience of drink-seeking behavior.
Time frame
24 monthsSecondary outcomes
1
Life Events Questionnaire (LEQ) Score
Life Events Questionnaire (LEQ): This questionnaire assesses positive and negative life events and their impact on participants
Time frame
24 monhts2
UCLA Loneliness Scale (UCLA-LS) Score
UCLA Loneliness Scale (UCLA-LS): This is a 20-item scale designed to measure a person s subjective feeling of loneliness and social isolation in the last month
Time frame
24 months3
Perceived Stress Scale (PSS) Score
Perceived stress scale (PSS): This is a 10-item scale to measure perception of stress
Time frame
24 monthsSponsors and contacts
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Source ClinicalTrials.gov