Building and Pilot Testing a Couples-based Smartphone Systems to Address Alcohol Use Disorder
Study Details
Study Description
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:
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Integrate A-CHESS with key features of ABCT to create PartnerCHESS to serve patients, partners, and clinicians.
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: A-CHESS Patients randomized to the A-CHESS group will receive the A-CHESS app on a smartphone. |
Behavioral: A-CHESS
A-CHESS control group
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| Experimental: PartnerCHESS 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
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.
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Outcome Measures
Primary Outcome Measures
- Change in number of patient risky drinking days [baseline, 2, 4, and 6 months']
Risky drinking day will be defined as greater than 4 drinks for men and greater than 3 drinks for women in 2 hours and will be measured through the Timeline Followback every 60 days.
- Change in number of days the patient did not drink [baseline, 2, 4, and 6 months']
Measured thru Timeline Followback every 60 days
- Change in number of alcohol problems [baseline, 2, 4, and 6 months']
The Short Inventory of Problems (SIP) assess consequences of drinking and is based on the Drinker Inventory of Consequences and measures consequences in 5 domains: interpersonal, intrapersonal, physical, impulse control, and social. Respondents indicate whether each item occurred in the last 30 days. Responses are summed across the 15 items to yield a total score. The higher the number the greater degree of consequences being experienced by the drinker.
Secondary Outcome Measures
- Change in Negative Affect as measured by the PANAS Questionnaire for both Patient and Partner [baseline, 2, 4, and 6 months']
The Positive and Negative Affect Schedule (PANAS) Questionnaire is comprised of two 10-item scales for both positive and negative affect. Each item on the negative affect scale is scored from 1 (very slightly or not at all) to 5 (extremely) for a total range of 10-50 where the higher the score, the more negative the affect.
- Change in Couple/Relationship Satisfaction for both Patient and Partner [baseline, 2, 4, and 6 months']
Determined by use of the Dyadic Adjustment Scale - 7 (DAS-7) which is a brief version of the 32 question Dyadic Adjustment Scale (DAS) and assesses the quality of marriage and similar dyads. The DAS-7 includes 4 subscales: Affectional Expression where the total range of scores is 0-12, the higher the score, the higher the affection; Cohesion subscale ranging from 0-24, the higher the score the more cohesive a relationship is; Consensus subscale ranging from 0-65, the higher the score the more consensus in the relationship; and the Satisfaction subscale ranging from 0-51, the higher the score the more satisfying the relationship.
- Change in Psychological Distress for both Patient and Partner [baseline, 2, 4, and 6 months']
The OQ45 measures the patient's and partner's outcomes during treatment by assessing three sub-domains, Symptom Distress, Interpersonal Relations, and Social Role. Scores from the Outcomes Questionnaire-45 range from 0-180, the higher the score, the higher the symptoms of distress
- Change in sleep disturbance for both Patient and Partner [baseline, 2, 4, and 6 months']
Assessed through a modified version of the PROMIS-29, specifically questions to address sleep quality and sleep difficulty over the last 7 days. The sleep portion of the PROMIS is a 4-item survey with a lowest possible score of 5 and a highest possible score of 20. A conversion table is used to convert the raw score into a T-score. The higher the T-score represents more of the concept being measured.
- Change in Pain for both Patient and Partner: PROMIS-29 [baseline, 2, 4, and 6 months']
Assessed through a modified version of the PROMIS-29, specifically questions to address pain interference and pain intensity over the last 7 days. The pain portion of the PROMIS is a 4-item survey with a lowest possible score of 5 and a highest possible score of 20. A conversion table is used to convert the raw score into a T-score. The higher the T-score represents more of the concept being measured.
- Change in Loneliness for both Patient and Partner [baseline, 2, 4, and 6 months']
Measured through the UCLA Loneliness Scale - 8 which is based on the longer UCLA Loneliness Scale, a 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Scores from the UCLA Loneliness Scale range from 0-60 where the higher the score, the more the feeling of loneliness.
Other Outcome Measures
- Change in number of Days Patient Used Other Drugs for Patient and Partner. [baseline, 2, 4, and 6 months']
Measured through administering the Timeline Followback every 60 days.
- Change in Relationship Violence [baseline, 2, 4, and 6 months']
Measured through use of the Conflict Tactics Scale which assesses the frequency of both non-violent and violent events. The CTS Scale is an 80-item survey where the total range of scores is 0-480, the higher the score the higher the intra-partner conflict.
- Change in number of other Health Service Interventions for Patient and Partner [baseline, 2, 4, and 6 months']
Determined by the Treatment Services Review (TSR) which assesses the nature and frequency of treatment services provided for a client in the following domains:Medical problems, Substance use (alcohol and drug) problems, Employment and support problems, Family problems, Legal problems, Psychological / emotional problems.
Eligibility Criteria
Criteria
A total of 40 dyads will be recruited.
Patients and partners:
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Must be 18 or older
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Not have a mental or physical condition that limits smartphone use
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Cannot have experienced serious Interpersonal ViolenceIntimate Partner Violence (IPV) in the index (therapy) relationship in the past year
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Not have a history of schizophrenia
Patients:
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Must have a DSM-5 diagnosis of alcohol use disorder or meet NIAAA guidelines for risky drinking.
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Have had at least one alcoholic drink in the last 6 months
Partners:
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Must be a spouse, or in a 6-month or longer committed romantic relationship
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Willing to participate in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanley Street Treatment and Resources | Fall River | Massachusetts | United States | 02720 |
Sponsors and Collaborators
- University of Wisconsin, Madison
- University of Massachusetts, Worcester
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
- Principal Investigator: David H Gustafson, PhD, University of Wisconsin, Madison
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018-0696
- A195010
- ENGR/INDUSTRIAL ENGR
- 1R34AA025675-01A1
- Protocol Version 7/6/2020