Alcohol Use DisorderNCT04059549
Building and Pilot Testing a Couples-based Smartphone Systems to Address Alcohol Use Disorder
A study testing PartnerCHESS and A-CHESS in people with Alcohol Use Disorder and Couples, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Couples, Behavior, Addictive
- What is being tested?
- PartnerCHESS and A-CHESS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2020to 29 Sep 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanley Street Treatment and Resources
Fall River, Massachusetts, 02720
About this study
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:
- Integrate A-CHESS with key features of ABCT to create PartnerCHESS to serve patients, partners, and clinicians.
- 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.
Read the 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:
- Integrate A-CHESS with key features of ABCT to create PartnerCHESS to serve patients, partners, and clinicians.
- 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
- Alcohol Use Disorder, Couples, Behavior, Addictive
- Being tested
- PartnerCHESS, A-CHESS
- Medical subject headings
- Alcoholism, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PartnerCHESSBehavioural
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.
A-CHESSBehavioural
A-CHESS control group
| Study group | Role | What they receive |
|---|---|---|
| A-CHESS Drinker | Active comparator | Patients randomized to the A-CHESS group will receive the A-CHESS app on a smartphone. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: PartnerCHESS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 2, 4, 6 months
Secondary outcomes (6)
Psychological Distress
Drinkers' and partners' psychological distress was assessed by the OQ-45 scale. Response options range from 0-4, with items 1, 12, 13, 20, 21, 24, 31, 37, and 43 reversed; items are summed (i.e., a possible range of 0-180). High scores suggest distress (anxiety, depression, somatic problems, stress), difficulties in interpersonal relationships and social roles (e.g., work), and low quality of life, with scores of 63 or more indicating symptoms of clinical significance, and changes of 14 points or more considered reliable.
Measured: baseline, 2, 4, and 6 months
Relationship Satisfaction
Drinkers' and partners' relationship satisfaction was assessed by the Dyadic Adjustment Scale-Brief (DAS-7) plus item 32 from the DAS-32. Response options ranged 0-5 on most items and 0-6 on item 7 of the DAS-7 (possible scores range from 0 to 41). Consistent with scoring instructions for the DAS-7, items were summed, with higher scores indicating more satisfaction.
Measured: baseline, 2, 4, and 6 months
Perceptions of Family Environment - Cohesion
Drinkers and partners both completed the 9-item Cohesion and 9-item Conflict scales from the Family Environment Scale. Responses were true/false statements, with higher scores indicating more cohesion or conflict. Possible scores range from 4 to 65.
Measured: Baseline, 2, 4, 6 months
Perceptions of Family Environment - Conflict
Drinkers and partners both completed the 9-item Cohesion and 9-item Conflict scales from the Family Environment Scale. Responses were true/false statements, with higher scores indicating more cohesion or conflict. Possible scores range from 33 to 80.
Measured: Baseline, 2, 4, 6 months
Commitment to Sobriety
Drinkers completed the 5-item Commitment to Sobriety Scale. Response options ranged 1-5 for a total possible range of scores from 5-25; with higher scores suggesting more commitment.
Measured: Baseline, 2, 4, 6 months
Peer Support
Partners reported on the availability of peer support using the 5-item McTavish Bonding Scale. Response options ranged 1-5 for a total possible range of scores from 5-25; with higher scores suggesting more support.
Measured: Baseline, 2, 4, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start17 Nov 2020
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Worcester, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- David H Gustafson, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059549
- Sponsor's protocol ID
- 2018-0696
- Other IDs
- A195010, ENGR/INDUSTRIAL ENGR, 1R34AA025675-01A1, Protocol Version 7/6/2020
- Status last verified
- Nov 2022
- First submitted
- 14 Aug 2019
- Last updated
- 22 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39486022