NCT05419128

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
398

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2024

Completed
10 months until next milestone

Results Posted

Study results publicly available

May 22, 2025

Completed
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

2.2 years

First QC Date

June 13, 2022

Results QC Date

May 1, 2025

Last Update Submit

February 16, 2026

Conditions

Keywords

mobile phone applicationsquality of lifeAlcohol Use Disorderfamily therapyhigh-risk drinkingalcohol behavioral couple therapyCOVID-19mHealtheHealthACHESSPartnerCHESS

Outcome Measures

Primary Outcomes (1)

  • % of Patient Risky Drinking Days

    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).

    8 and 12 months

Secondary Outcomes (3)

  • Psychological Distress

    Baseline, 4, 8, and 12 months

  • % Days Abstinent

    Baseline, 4, 8, and 12 months

  • Relationship Satisfaction

    Baseline, 4, 8, and 12 months

Other Outcomes (1)

  • % of Patient Risky Drinking Days

    Baseline, 4 months

Study Arms (3)

ACHESS

ACTIVE COMPARATOR

In ACHESS, both the identified patient and the concerned significant other will receive a smartphone, but only the identified patient will receive the ACHESS app. The concerned significant other will receive a smartphone with contact information for standard AUD, SUD, and crisis support.

Behavioral: ACHESS

PartnerCHESS

EXPERIMENTAL

In the PartnerCHESS arm, identified patient and concerned significant other will both receive a smartphone with the PartnerCHESS app, which contains ACHESS services plus ABCT/ PartnerCHESS services.

Behavioral: PartnerCHESS

Smartphone Control

NO INTERVENTION

Both the identified patient and concerned significant other will receive a smartphone with pre-programmed contact information for Alcoholics Anonymous (AA), Narcotics Anonymous (NA), Al-Anon, Adult Children of Alcoholics (ACOA), and crisis hot lines.

Interventions

ACHESSBEHAVIORAL

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

ACHESS
PartnerCHESSBEHAVIORAL

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.

PartnerCHESS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

MeSH Terms

Conditions

AlcoholismBehavior, AddictiveCOVID-19

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Kasey Thompson
Organization
CHESS - University of Wisconsin--Madison

Study Officials

  • David Gustafson, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2022

First Posted

June 15, 2022

Study Start

April 6, 2022

Primary Completion

July 2, 2024

Study Completion

July 17, 2024

Last Updated

February 19, 2026

Results First Posted

May 22, 2025

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations