Clinical trial NCT04059549: Building and Pilot Testing a Couples-based Smartphone Systems to Address Alcohol Use Disorder
Official title: Building and Pilot Testing a Couples-based Smartphone Systems to Address Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Couples
Behavior, Addictive
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Worcester
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-08-16
Enrollment: 68
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 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. Integrate A-CHESS with key features of ABCT to create PartnerCHESS to serve patients, partners, and clinicians.
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.

3a. Decide whether to pursue an R01 application, and if so, 3b. plan for the R01.

Detailed description: Alcohol use disorder (AUD) is one of the most common substance use disorders. Yet only a small fraction of people who need treatment receive it, and most of them get only short-term support even though continuing care has been shown to be much more effective. Partner support can be critical to recovery, but many partners do not know how to support their partners' recovery or manage their own responses to it. Clinicians also lack evidence of the efforts patients are making toward recovery. Treating couples in which one member is recovering from AUD has been shown to be efficacious; in particular, Alcohol Behavioral Couples Therapy (ABCT) has shown positive outcomes. Still, ABCT has not been widely adopted, in part because of practical problems such as the stigma that goes with the partner needing to go to an addiction treatment agency to participate. A-CHESS is a smartphone-based system proven to substantially reduce relapse rates, but A-CHESS serves only the patient.

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. Integrate A-CHESS with key features of ABCT to create PartnerCHESS to serve patients, partners, and clinicians.
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.

3a. Decide whether to pursue an R01 application, and if so, 3b. plan for the R01.

The project would engage 6 couples to help design PartnerCHESS, test its usability and give feedback on its utility. Once ready, the system would be tested by 34 other couples randomized to receive either PartnerCHESS + treatment as usual (TAU) or A-CHESS + TAU for a 6-month trial. The investigators will collect survey data at baseline, 2, 4, and 6 months and analyze it to see if a large clinical trial holds promise and, if so, produce an application to support a full-scale trial based on the technology developed and the research procedures employed in the pilot test.

The study is important to public health because of the scope of the alcohol abuse and the potential of technology to improve the lives of both patients and partners. If successful, such technology could greatly broaden the reach and impact of AUD treatment in general and couples therapy in particular.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With no Heavy Drinking
timeFrame: baseline, 2, 4, and 6 months
measure: Percentage of Days With Heavy Drinking
timeFrame: baseline, 2, 4, and 6 months
measure: Percentage of Days With Any Drinking
timeFrame: Baseline, 2, 4, 6 months
Secondary outcomes:
measure: Psychological Distress
timeFrame: baseline, 2, 4, and 6 months
measure: Relationship Satisfaction
timeFrame: baseline, 2, 4, and 6 months
measure: Perceptions of Family Environment - Cohesion
timeFrame: Baseline, 2, 4, 6 months
measure: Perceptions of Family Environment - Conflict
timeFrame: Baseline, 2, 4, 6 months
measure: Commitment to Sobriety
timeFrame: Baseline, 2, 4, 6 months
measure: Peer Support
timeFrame: Baseline, 2, 4, 6 months
Other outcomes:
Locations:
city: Fall River
country: United States
facility: Stanley Street Treatment and Resources
state: Massachusetts
Study officials:
affiliation: University of Wisconsin, Madison
name: David H Gustafson, PhD
role: PRINCIPAL_INVESTIGATOR
References: