- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05419128
Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19
Study Overview
Status
Intervention / Treatment
Detailed Description
The current randomized controlled trial tested whether PartnerCHESS (an ACHESS intervention along with aspects of Alcohol Behavioral Couple Therapy designed specifically for individuals with alcohol use disorder and their concerned significant other) could reduce high-risk drinking and improve quality of life.
For this trial, 199 dyads (398 participants) were recruited from the community and randomized 1:1:1 to the PartnerCHESS intervention, ACHESS intervention, or smartphone control for 8 months with a follow-up at 12 months. Participants were part of a dyad: identified patients met criteria for high-risk drinking (defined by the DSM-5) and had at least one drink in the past month, concerned significant others were the identified patient's romantic partner, family member, or close friend aged 21 or older. Primary outcomes were identified patient percent high-risk drinking days, and quality of life for both identified patients and concerned significant others. Participants were surveyed at baseline, 4, 8, and 12 months; PartnerCHESS and ACHESS usage data were continuously collected.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Wisconsin
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Madison, Wisconsin, United States, 53706
- University of Wisconsin
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Identified patients and their concerned significant others 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. Identified patients must be age 18 or older and meet criteria for risky drinking (for men, >4 standard drinks in a day; for women, >3 in a day), or meet criteria for AUD (any severity) defined by DSM-5 and have had at least 1 drink in the past 3 months . Partner must be a committed romantic partner/spouse, close friend or family member (e.g. sibling, parent, grandparent, adult child age 21 or older).
Exclusion Criteria:
- Individuals were not eligible if they had current (last 6 months) evidence of serious mental illness (eg, active psychosis, active manic phase), or if either partner reported serious interpersonal violence, to avoid risk of violence from engagement on potentially sensitive subjects.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: ACHESS
In ACHESS, both the identified patient and the concerned significant other will receive a smartphone, but only the identified patient will receive the ACHESS app.
The concerned significant other will receive a smartphone with contact information for standard AUD, SUD, and crisis support.
|
ACHESS offers the following, which are also available in PartnerCHESS: Covid content, Instant Library, Discussion Groups, Personal Stories, Location Monitor, Surveys and Ecological Momentary Assessments, Guided Relaxation, Healthy Activities, Crisis Button, Skills Reminders
|
|
Experimental: PartnerCHESS
In the PartnerCHESS arm, identified patient and concerned significant other will both receive a smartphone with the PartnerCHESS app, which contains ACHESS services plus ABCT/ PartnerCHESS services.
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The following ABCT services, from PartnerCHESS, will be available in the PartnerCHESS app but not in ACHESS: ABCT tutorials. Interactive e-learning modules explaining key ABCT skills. Agreements between identified patient and concerned significant other to follow key principles. Trigger identification and removal. Cravings discussion. Relapse plan. Reminders. |
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No Intervention: Smartphone Control
Both the identified patient and concerned significant other 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
% of Patient Risky Drinking Days
Time Frame: 8 and 12 months
|
Risky drinking day will be defined as greater than 4 drinks for men and greater than 3 drinks for women and will be measured through the Timeline Followback every 120 days.
8 months was the end of the intervention, 12 months was the final follow-up (4 months after the intervention ended).
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8 and 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological Distress
Time Frame: Baseline, 4, 8, and 12 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.
Cut-off score: 63 or more - indicates symptoms of clinical significance A high score suggests that the client is admitting to a large number of symptoms of distress (mainly anxiety, depression, somatic problems and stress) as well as difficulties in interpersonal relationships, social role (such as work or school), and in their general quality of life.
Reliable change: indicated when a client's score changes by 14 points or more.
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Baseline, 4, 8, and 12 months
|
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% Days Abstinent
Time Frame: Baseline, 4, 8, and 12 months
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% days abstinent will be measured through the Timeline Followback every 120 days.
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Baseline, 4, 8, and 12 months
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Relationship Satisfaction
Time Frame: Baseline, 4, 8, and 12 months
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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.
Possible range is 0-36.
Higher scores indicate more positive relationship quality.
Scores less than 21 are considered to indicate a relationship in distress.
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Baseline, 4, 8, and 12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
% of Patient Risky Drinking Days
Time Frame: Baseline, 4 months
|
Risky drinking day will be defined as greater than 4 drinks for men and greater than 3 drinks for women and will be measured through the Timeline Followback every 120 days.
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Baseline, 4 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Gustafson, PhD, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Substance-Related Disorders
- Chemically-Induced Disorders
- Alcohol-Related Disorders
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Compulsive Behavior
- Impulsive Behavior
- Behavior
- COVID-19
- Alcoholism
- Behavior, Addictive
Other Study ID Numbers
- 2021-0943
- 5R01AA029804 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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