Building and Pilot Testing a Couples-based Smartphone Systems to Address Alcohol Use Disorder

NCT04059549 | Completed Results DMC

• 5 other identifiers: 2018-0696A195010ENGR/INDUSTRIAL ENGR1R34AA025675-01A1Protocol Version 7/6/2020
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This project will develop and pilot test a new smartphone-based system for AUD patients, their partners, and clinicians called PartnerCHESS. PartnerCHESS will integrate key features of ABCT and A-CHESS. PartnerCHESS will also include a Clinician Report to automatically alert clinicians of patients at risk of relapse and offer other information on how recovery is proceeding. The project has three specific aims:

1. 1.Integrate A-CHESS with key features of ABCT to create PartnerCHESS to serve patients, partners, and clinicians.
2. 2.Conduct a pilot test (a small randomized clinical trial) of PartnerCHESS to estimate effect size and refine the protocol, procedures, recruitment strategy, measurements, and operations for use in a large RCT.

Conditions

Alcohol Use Disorder; Couples; Behavior, Addictive

Outcome Measures

Primary Outcomes (3)

• Number of Participants With no Heavy Drinking

  At each time of measurement, a timeline follow-back interview was conducted for the past 60 days. Risky drinking day was be defined as greater than 4 drinks for men and greater than 3 drinks for women in 2 hours.

  baseline, 2, 4, and 6 months

• Percentage of Days With Heavy Drinking

  At each time of measurement, a timeline follow-back interview was conducted for the past 60 days.

  baseline, 2, 4, and 6 months

• Percentage of Days With Any Drinking

  At each time of measurement, a timeline follow-back interview was conducted for the past 60 days.

  Baseline, 2, 4, 6 months

Secondary Outcomes (6)

• Psychological Distress

  baseline, 2, 4, and 6 months

• Relationship Satisfaction

  baseline, 2, 4, and 6 months

• Perceptions of Family Environment - Cohesion

  Baseline, 2, 4, 6 months

• Perceptions of Family Environment - Conflict

  Baseline, 2, 4, 6 months

• Commitment to Sobriety

  Baseline, 2, 4, 6 months

Study Arms (4)

A-CHESS Drinker

ACTIVE COMPARATOR

Patients randomized to the A-CHESS group will receive the A-CHESS app on a smartphone.

Behavioral: A-CHESS

PartnerCHESS Drinker

EXPERIMENTAL

Patients randomized to the PartnerCHESS group will receive all A-CHESS services listed above, plus learning modules and resources from Alcohol-based Couple Therapy.

Behavioral: PartnerCHESS

A-CHESS Partner

ACTIVE COMPARATOR

Patient's partner randomized to the A-CHESS group will receive the A-CHESS app on a smartphone.

Behavioral: A-CHESS

PartnerCHESS Partner

EXPERIMENTAL

Patient's partner randomized to the PartnerCHESS group will receive all A-CHESS services listed above, plus learning modules and resources from Alcohol-based Couple Therapy.

Behavioral: PartnerCHESS

Interventions

PartnerCHESS BEHAVIORAL

Patients randomized to the PartnerCHESS group will receive all A-CHESS services plus the following services from ABCT: Urge discussion. Daily EMAs will track preconditions for relapse (urges), review urge reduction options on PartnerCHESS, and encourage discussions between partners on the causes of and ways to reduce urges. Homework checklist. Tracks which interventions the couple is using/practicing, along with resources to help. Relapse plan. Monitoring and reminders of steps planned for relapse prevention. Reminders. Reminders to notice something positive in partner, of reasons to stay sober, to take meds, etc. Trigger identification and removal. During set-up, patient and partner enter triggers. PartnerCHESS will quiz couples on upcoming trigger events and remind them of ways to address each.

PartnerCHESS Drinker; PartnerCHESS Partner

A-CHESS BEHAVIORAL

A-CHESS control group

A-CHESS Drinker; A-CHESS Partner

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

A total of 34 dyads were recruited. Patients and partners: * Must be 18 or older * Not have a mental or physical condition that limits smartphone use * Cannot have experienced serious Interpersonal Violence Intimate Partner Violence (IPV) in the index (therapy) relationship in the past year * Not have a history of schizophrenia Patients: * Must have a DSM-5 diagnosis of alcohol use disorder or meet NIAAA guidelines for risky drinking. * Have had at least one alcoholic drink in the last 6 months Partners: * Must be a spouse, or in a 6-month or longer committed romantic relationship * Willing to participate in the study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• University of Massachusetts, Worcester: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Stanley Street Treatment and Resources

Fall River, Massachusetts, 02720, United States

Location

Related Publications (1)

• Gustafson DH Sr, Gustafson DH Jr, Mares ML, Johnston DC, Vjorn OJ, Curtin JJ, Epstein EE, Bailey GL. Couple-Focused Smartphone Intervention to Reduce Problem Drinking: Pilot Randomized Control Trial. JMIR Form Res. 2024 Nov 1;8:e58622. doi: 10.2196/58622.

  PMID: 39486022 DERIVED

MeSH Terms

Conditions

Alcoholism; Behavior, Addictive

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Results Point of Contact

• Title: Olivia Vjorn
• Organization: UW Madison

ocody@wisc.edu

6084772614

Study Officials

• David H Gustafson, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: August 14, 2019
• First Posted: August 16, 2019
• Study Start: November 17, 2020
• Primary Completion: September 29, 2021
• Study Completion: September 29, 2021
• Last Updated: April 22, 2025
• Results First Posted: December 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)