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Completed

NCT Number: NCT05419128

Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19

This R01 project titled "Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19" is a Hybrid II RCT/implementation study to modify and test two of our alcohol smartphone interventions to address the fallout from COVID. We propose a three-arm RCT comparing a smartphone control group vs. a drinker-focused intervention vs. a family-focused intervention. All study arms recruit dyads comprising a person who drinks and a family partner.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Behavior Behavior, Addictive COVID-19 Chemically-Induced Disorders Compulsive Behavior Coronaviridae Infections Coronavirus Infections Family Members Impulsive Behavior Infections Lung Diseases Mental Disorders Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Substance-Related Disorders Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53706, United States

About this study

The current randomized controlled trial tested whether PartnerCHESS (an ACHESS intervention along with aspects of Alcohol Behavioral Couple Therapy designed specifically for individuals with alcohol use disorder and their concerned significant other) could reduce high-risk drinking and improve quality of life.

For this trial, 199 dyads (398 participants) were recruited from the community and randomized 1:1:1 to the PartnerCHESS intervention, ACHESS intervention, or smartphone control for 8 months with a follow-up at 12 months. Participants were part of a dyad: identified patients met criteria for high-risk drinking (defined by the DSM-5) and had at least one drink in the past month, concerned significant others were the identified patient's romantic partner, family member, or close friend aged 21 or older. Primary outcomes were identified patient percent high-risk drinking days, and quality of life for both identified patients and concerned significant others. Participants were surveyed at baseline, 4, 8, and 12 months; PartnerCHESS and ACHESS usage data were continuously collected.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Identified patients and their concerned significant others must give informed consent; agree to complete interviews at baseline, 4, 8, and 12 months; and not have a mental or physical condition that limits smartphone use. Identified patients must be age 18 or older and meet criteria for risky drinking (for men, >4 standard drinks in a day; for women, >3 in a day), or meet criteria for AUD (any severity) defined by DSM-5 and have had at least 1 drink in the past 3 months . Partner must be a committed romantic partner/spouse, close friend or family member (e.g. sibling, parent, grandparent, adult child age 21 or older).

Exclusion criteria

  • Individuals were not eligible if they had current (last 6 months) evidence of serious mental illness (eg, active psychosis, active manic phase), or if either partner reported serious interpersonal violence, to avoid risk of violence from engagement on potentially sensitive subjects.

Treatment and study plan

PartnerCHESS

Behavioral

The following ABCT services, from PartnerCHESS, will be available in the PartnerCHESS app but not in ACHESS:

ABCT tutorials. Interactive e-learning modules explaining key ABCT skills. Agreements between identified patient and concerned significant other to follow key principles.

Trigger identification and removal. Cravings discussion. Relapse plan. Reminders.

ACHESS

Behavioral

ACHESS offers the following, which are also available in PartnerCHESS: Covid content, Instant Library, Discussion Groups, Personal Stories, Location Monitor, Surveys and Ecological Momentary Assessments, Guided Relaxation, Healthy Activities, Crisis Button, Skills Reminders

Primary outcomes

  1. % of Patient Risky Drinking Days

    Time frame: 8 and 12 months

    Risky drinking day will be defined as greater than 4 drinks for men and greater than 3 drinks for women and will be measured through the Timeline Followback every 120 days. 8 months was the end of the intervention, 12 months was the final follow-up (4 months after the intervention ended).

Secondary outcomes

  1. Psychological Distress

    Time frame: Baseline, 4, 8, and 12 months

    The OQ45 measures the patient's and partner's outcomes during treatment by assessing three sub-domains, Symptom Distress, Interpersonal Relations, and Social Role. Scores from the Outcomes Questionnaire-45 range from 0-180, the higher the score, the higher the symptoms of distress. Cut-off score: 63 or more - indicates symptoms of clinical significance A high score suggests that the client is admitting to a large number of symptoms of distress (mainly anxiety, depression, somatic problems and stress) as well as difficulties in interpersonal relationships, social role (such as work or school), and in their general quality of life. Reliable change: indicated when a client's score changes by 14 points or more.

  2. % Days Abstinent

    Time frame: Baseline, 4, 8, and 12 months

    % days abstinent will be measured through the Timeline Followback every 120 days.

  3. Relationship Satisfaction

    Time frame: Baseline, 4, 8, and 12 months

    Determined by use of the Dyadic Adjustment Scale - 7 (DAS-7) which is a brief version of the 32 question Dyadic Adjustment Scale (DAS) and assesses the quality of marriage and similar dyads. Possible range is 0-36. Higher scores indicate more positive relationship quality. Scores less than 21 are considered to indicate a relationship in distress.

Other outcomes

  1. % of Patient Risky Drinking Days

    Time frame: Baseline, 4 months

    Risky drinking day will be defined as greater than 4 drinks for men and greater than 3 drinks for women and will be measured through the Timeline Followback every 120 days.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2022
Registry last updated
Feb 19, 2026

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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