Clinical trial NCT05419128: Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19
Official title: Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Family Members
Behavior, Addictive
Keywords: mobile phone applications
quality of life
Alcohol Use Disorder
family therapy
high-risk drinking
alcohol behavioral couple therapy
COVID-19
mHealth
eHealth
ACHESS
PartnerCHESS
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-06-15
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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. We found significant difference in both PartnerCHESS and ACHESS arms compared to smartphone control in percent high-risk drinking days as well as identified patient quality of life. Additionally, PartnerCHESS had significantly lower percent high-risk drinking days than ACHESS at 12 months, suggesting a stronger long-term impact. We also found significantly less distress among ACHESS concerned significant others as compared to those in PartnerCHESS and the smartphone control arms.

Eligibility criteria: 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.

Primary outcomes:
measure: % of Patient Risky Drinking Days
timeFrame: Baseline, 4, 8, and 12 months
measure: Psychological Distress
timeFrame: Baseline, 4, 8, and 12 months
Secondary outcomes:
measure: % Days Abstinent
timeFrame: Baseline, 4, 8, and 12 months
measure: Relationship Satisfaction
timeFrame: Baseline, 4, 8, and 12 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: David Gustafson, PhD
role: PRINCIPAL_INVESTIGATOR
References: