Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19

Alcohol Use Disorder Clinical Trial

Official title:

Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05419128
• Other study ID #: 2021-0943
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 25, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

this R01 project titled "Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19" is a Hybrid II RCT/implementation study to modify and test two of our alcohol smartphone interventions to address the fallout from COVID. We propose a three-arm RCT comparing a smartphone control group vs. a drinker-focused intervention vs. a family-focused intervention. All study arms recruit dyads comprising a person who drinks and a family partner.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Drinkers and their family partners must give informed consent; agree to complete interviews at baseline, 4, 8, and 12 months; and not have a mental or physical condition that limits smartphone use. Drinkers must be age 18 or older and meet criteria for risky drinking (for men, >14 standard drinks in a week or >4 in a day; for women, >7 in a week or >3 in a day),76 or meet criteria for AUD (any severity) defined by DSM-5 and have had at least 1 drink in the past 3 months .77 Partner must be a committed romantic partner, spouse, or family member (e.g. sibling, parent, grandparent, adult child age 21 or older).

Exclusion Criteria:

• Current (last 6 months) evidence of unstabilized serious mental illness (active psychosis, delusions, hallucinations, active manic phase). We will also exclude dyads if either partner reports serious interpersonal violence in the past year, because of potential safety risk owing to access to a partner's smartphone or computer.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Behavior, Addictive
• Family Members

Intervention

Behavioral:
• PartnerCHESS
The following ABCT services, from PartnerCHESS, will be available in the FamCHESS-C app but not in ACHESS-C: ABCT tutorials. Interactive e-learning modules explaining key ABCT skills. Agreements between drinker and partner to follow key principles. Trigger identification and removal. Cravings discussion. Relapse plan. Reminders.
• ACHESS
ACHESS-C offers the following, which are also available in FamCHESS-C: Covid content, Instant Library, Discussion Groups, Personal Stories, Location Monitor, Surveys and Ecological Momentary Assessments, Guided Relaxation, Healthy Activities, Crisis Button, Skills Reminders

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in sleep disturbance for both Patient and Partner	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.	Baseline, 4, 8, and 12 months
Other	Change in Pain for both Patient and Partner: PROMIS-29	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.	Baseline, 4, 8, and 12 months
Other	Change in Loneliness for both Patient and Partner	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.	Baseline, 4, 8, and 12 months
Other	Change in number of Days Patient Used Other Drugs for Patient and Partner.	Measured through administering the Timeline Followback every 120 days.	Baseline, 4, 8, and 12 months
Other	Crisis Health Services Use (ER, 30-day readmits)	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.	Baseline, 4, 8, and 12 months
Primary	Change in number of patient risky drinking days	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 120 days.	Baseline, 4, 8, and 12 months
Primary	Change in psychological distress	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	Baseline, 4, 8, and 12 months
Secondary	Change in % days drinking & other drug use	% days drinking & other drug use will be measured through the Timeline Followback every 120 days.	Baseline, 4, 8, and 12 months
Secondary	Change in no risky drinking days	No risky drinking days will be measured through the Timeline Followback every 120 days.	Baseline, 4, 8, and 12 months
Secondary	Change in number of alcohol problems	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.	Baseline, 4, 8, and 12 months
Secondary	Change in couple alcohol-related communication	The 20-item Partner Interaction Questionnaire (PIQ-20) will be used to assess social support for adults wanting to stop drinking.	Baseline, 4, 8, and 12 months
Secondary	Change in relationship satisfaction	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.	Baseline, 4, 8, and 12 months
Secondary	Change in depressive symptoms	The PHQ-8 is the depression module, which scores each of the eight DSM-IV criteria as "0" (not at all) to "3" (nearly every day). It has been validated for use in primary care. It is not a screening tool for depression but it is used to monitor the severity of depression and response to treatment.	Baseline, 4, 8, and 12 months
Secondary	Change in partner abusive behaviors	A 15-item version of the Composite Abuse Scale (Revised)-Short Form, CASR-SF is brief self-report measure of IPV experiences among women that has demonstrated initial reliability and validity and is suitable for use in population studies or other studies.	Baseline, 4, 8, and 12 months
Secondary	Change in Covid Vaccination/Infection	2 questions asking if the individual has been vaccinated or had covid greater then 4 months ago.	Baseline, 4, 8, and 12 months