Wearable Technology and Alcohol-Facilitated Intimate Partner Violence
United States92 participantsStarted 2023-01-27
Plain-language 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 wearable activity trackers (like a smart watch) and use of a cell phone application (app) among couples. The investigators are also testing the use of this device and app will affect alcohol use and couple conflict.
This study involves a screening phase and a 28 observation period where participants are asked to wear a smart watch, complete assessments and provide feedback.
Who can participate
Age range
21 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Heart Rate Variability During Alcohol-Facilitated Intimate Partner Violence (IPV)
Timeframe: From enrollment through end of evaluation period; 28 days.
2
Usability of Heart Rate Variability-Biofeedback Intervention
Timeframe: During the exit interview, following 28 days of ecological momentary assessment (EMA).
3
Feasibility of Heart Rate Variability-Biofeedback Intervention
Timeframe: From days 21-28 during the Heart Rate Variability-Biofeedback (HRV-B) intervention; 7 days.
4
Acceptability of Heart Rate Variability-Biofeedback Intervention
Timeframe: During the exit interview, following 28 days of ecological momentary assessment (EMA).
. 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.