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

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Recruiting
CT.gov ID
NCT05419128
Collaborator
(none)
396
1
3
35.2
11.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: PartnerCHESS
  • Behavioral: ACHESS
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
396 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19
Actual Study Start Date :
Sep 25, 2021
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: ACHESS-C

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.

Behavioral: 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

Experimental: FamCHESS-C

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.

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.

No Intervention: Control

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.

Outcome Measures

Primary Outcome Measures

  1. Change in number of patient risky drinking days [Baseline, 4, 8, and 12 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 120 days.

  2. Change in psychological distress [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

Secondary Outcome Measures

  1. Change in % days drinking & other drug use [Baseline, 4, 8, and 12 months]

    % days drinking & other drug use will be measured through the Timeline Followback every 120 days.

  2. Change in no risky drinking days [Baseline, 4, 8, and 12 months]

    No risky drinking days will be measured through the Timeline Followback every 120 days.

  3. Change in number of alcohol problems [Baseline, 4, 8, and 12 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.

  4. Change in couple alcohol-related communication [Baseline, 4, 8, and 12 months]

    The 20-item Partner Interaction Questionnaire (PIQ-20) will be used to assess social support for adults wanting to stop drinking.

  5. Change in relationship satisfaction [Baseline, 4, 8, and 12 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.

  6. Change in depressive symptoms [Baseline, 4, 8, and 12 months]

    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.

  7. Change in partner abusive behaviors [Baseline, 4, 8, and 12 months]

    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.

  8. Change in Covid Vaccination/Infection [Baseline, 4, 8, and 12 months]

    2 questions asking if the individual has been vaccinated or had covid greater then 4 months ago.

Other Outcome Measures

  1. Change in sleep disturbance for both Patient and Partner [Baseline, 4, 8, and 12 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.

  2. Change in Pain for both Patient and Partner: PROMIS-29 [Baseline, 4, 8, and 12 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.

  3. Change in Loneliness for both Patient and Partner [Baseline, 4, 8, and 12 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.

  4. Change in number of Days Patient Used Other Drugs for Patient and Partner. [Baseline, 4, 8, and 12 months]

    Measured through administering the Timeline Followback every 120 days.

  5. Crisis Health Services Use (ER, 30-day readmits) [Baseline, 4, 8, and 12 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Wisconsin Madison Wisconsin United States 53706

Sponsors and Collaborators

  • University of Wisconsin, Madison

Investigators

  • Principal Investigator: David Gustafson, PhD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT05419128
Other Study ID Numbers:
  • 2021-0943
First Posted:
Jun 15, 2022
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 5, 2022