Trials / Completed
CompletedNCT04059549
Building and Pilot Testing a Couples-based Smartphone Systems to Address Alcohol Use Disorder
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- University of Wisconsin, Madison · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | PartnerCHESS | 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. |
| BEHAVIORAL | A-CHESS | A-CHESS control group |
Timeline
- Start date
- 2020-11-17
- Primary completion
- 2021-09-29
- Completion
- 2021-09-29
- First posted
- 2019-08-16
- Last updated
- 2025-04-22
- Results posted
- 2022-12-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04059549. Inclusion in this directory is not an endorsement.