Status:
COMPLETED
Wearable Technology and Alcohol-Facilitated Intimate Partner Violence
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Abuse
IPV
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
This project seeks to develop interactive treatment options to successfully reduce AUD and IPV concurrently. The purpose of the study is to examine the usability, feasibility, and acceptability of wea...
Detailed Description
Alcohol use disorder (AUD) and acute alcohol intoxication are well-established precipitants of intimate partner violence (IPV). Approximately one third of U.S. adults experience IPV during their lifet...
Eligibility Criteria
Inclusion
- Any gender identity; any race or ethnicity; any sexual orientation; aged 21-70 years.
- Married, cohabiting, or in a committed relationship for ≥ 6 months.
- English fluency and cognitive functioning sufficient to provide informed consent and participate accurately (score ≥ 26 on the Mini-Mental Status Exam \[MMSE\]).
- At least one partner within each dyad must meet DSM-V diagnostic criteria for current AUD (assessed by the QuickSCID) and consume ≥ 2 hazardous drinking episodes (i.e., 4 or more drinks for women, 5 or more for men in ≤ 2 hours) per month in the past three months.
- At least one partner within each dyad must endorse ≥1 instance of IPV with their current partner in the past 6 months (assessed by the Revised Conflict Tactics Scale \[CTS-2\]).
- Maintenance of psychotropic medications on a stable dose for at least 4 weeks before study initiation.
Exclusion
- Meeting DSM-5 criteria for a history of or current psychotic or bipolar disorders.
- Meeting DSM-5 diagnostic criteria for moderate or severe drug use disorder (e.g., cannabis). Concurrent mild drug use disorders are acceptable due to the marked co-occurrence in AUD populations.
- Alcohol withdrawal as indicated by CIWA-Ar scores \>8.
- Current suicidal or homicidal ideation and intent.
- Serious cardiovascular health conditions (e.g., pacemaker, cardiac arrhythmia, hypertension) because the safety of HRV-B has not yet been established in these populations.
- Treatment on medications such as lithium, methadone, alpha or beta blockers or cholinergic/ anticholinergic medications likely to confound normative cardiovascular responding.
- Current neurologic conditions or history of traumatic brain injury.
- Severe and unilateral IPV in the past 6 months.
- Current pregnancy.
Key Trial Info
Start Date :
January 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2024
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT05374798
Start Date
January 27 2023
End Date
May 28 2024
Last Update
July 14 2025
Active Locations (1)
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1
Addiction Sciences Division-Medical University of South Carolina
Charleston, South Carolina, United States, 29425