Back to resultsFamily-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19
Primary Purpose
Alcohol Use Disorder, Family Members, Behavior, Addictive
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PartnerCHESS
ACHESS
Sponsored by
About this trial
This is an interventional supportive care trial for Alcohol Use Disorder
Eligibility Criteria
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.
Sites / Locations
- University of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
No Intervention
Arm Label
ACHESS-C
FamCHESS-C
Control
Arm Description
In ACHESS-C, both the drinker and the partner will receive a smartphone, but only the drinker will receive the ACHESS-C app. The partner will receive a smartphone with contact information for standard AUD, SUD, and crisis support.
In the FamCHESS-C arm, drinker and partner will both receive a smartphone with the FamCHESS-C app, which contains ACHESS-C services plus ABCT/ PartnerCHESS services.
Both the drinker and family partner will receive a smartphone with pre-programmed contact information for Alcoholics Anonymous (AA), Narcotics Anonymous (NA), Al-Anon, Adult Children of Alcoholics (ACOA), and crisis hot lines.
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Change in % days drinking & other drug use
% days drinking & other drug use will be measured through the Timeline Followback every 120 days.
Change in no risky drinking days
No risky drinking days will be measured through the Timeline Followback every 120 days.
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.
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.
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.
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.
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.
Change in Covid Vaccination/Infection
2 questions asking if the individual has been vaccinated or had covid greater then 4 months ago.
Full Information
NCT ID
NCT05419128
First Posted
June 13, 2022
Last Updated
July 13, 2023
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT05419128
Brief Title
Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19
Official Title
Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 25, 2021 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Family Members, Behavior, Addictive
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
398 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACHESS-C
Arm Type
Active Comparator
Arm Description
In ACHESS-C, both the drinker and the partner will receive a smartphone, but only the drinker will receive the ACHESS-C app. The partner will receive a smartphone with contact information for standard AUD, SUD, and crisis support.
Arm Title
FamCHESS-C
Arm Type
Experimental
Arm Description
In the FamCHESS-C arm, drinker and partner will both receive a smartphone with the FamCHESS-C app, which contains ACHESS-C services plus ABCT/ PartnerCHESS services.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Both the drinker and family partner will receive a smartphone with pre-programmed contact information for Alcoholics Anonymous (AA), Narcotics Anonymous (NA), Al-Anon, Adult Children of Alcoholics (ACOA), and crisis hot lines.
Intervention Type
Behavioral
Intervention Name(s)
PartnerCHESS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ACHESS
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in number of patient risky drinking days
Description
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.
Time Frame
Baseline, 4, 8, and 12 months
Title
Change in psychological distress
Description
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
Time Frame
Baseline, 4, 8, and 12 months
Secondary Outcome Measure Information:
Title
Change in % days drinking & other drug use
Description
% days drinking & other drug use will be measured through the Timeline Followback every 120 days.
Time Frame
Baseline, 4, 8, and 12 months
Title
Change in no risky drinking days
Description
No risky drinking days will be measured through the Timeline Followback every 120 days.
Time Frame
Baseline, 4, 8, and 12 months
Title
Change in number of alcohol problems
Description
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.
Time Frame
Baseline, 4, 8, and 12 months
Title
Change in couple alcohol-related communication
Description
The 20-item Partner Interaction Questionnaire (PIQ-20) will be used to assess social support for adults wanting to stop drinking.
Time Frame
Baseline, 4, 8, and 12 months
Title
Change in relationship satisfaction
Description
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.
Time Frame
Baseline, 4, 8, and 12 months
Title
Change in depressive symptoms
Description
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.
Time Frame
Baseline, 4, 8, and 12 months
Title
Change in partner abusive behaviors
Description
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.
Time Frame
Baseline, 4, 8, and 12 months
Title
Change in Covid Vaccination/Infection
Description
2 questions asking if the individual has been vaccinated or had covid greater then 4 months ago.
Time Frame
Baseline, 4, 8, and 12 months
Other Pre-specified Outcome Measures:
Title
Change in sleep disturbance for both Patient and Partner
Description
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.
Time Frame
Baseline, 4, 8, and 12 months
Title
Change in Pain for both Patient and Partner: PROMIS-29
Description
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.
Time Frame
Baseline, 4, 8, and 12 months
Title
Change in Loneliness for both Patient and Partner
Description
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.
Time Frame
Baseline, 4, 8, and 12 months
Title
Change in number of Days Patient Used Other Drugs for Patient and Partner.
Description
Measured through administering the Timeline Followback every 120 days.
Time Frame
Baseline, 4, 8, and 12 months
Title
Crisis Health Services Use (ER, 30-day readmits)
Description
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.
Time Frame
Baseline, 4, 8, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Gustafson, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19
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