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

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04059549
• Other study ID #: 2018-0696
• Secondary ID: A195010ENGR/INDU
• Status: Completed
• Phase: N/A
• Start date: November 17, 2020
• Est. completion date: September 29, 2021

Study information

• Verified date: November 2022
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 29, 2021
• Est. primary completion date: September 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Behavior, Addictive
• Couples

Intervention

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.
• A-CHESS
A-CHESS control group

Locations

Country	Name	City	State
United States	Stanley Street Treatment and Resources	Fall River	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	baseline, 2, 4, and 6 months
Secondary	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.	baseline, 2, 4, and 6 months
Secondary	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.	Baseline, 2, 4, 6 months
Secondary	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.	Baseline, 2, 4, 6 months
Secondary	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.	Baseline, 2, 4, 6 months
Secondary	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.	Baseline, 2, 4, 6 months