N/A
N=92
Wearable Technology and Alcohol-Facilitated Intimate Partner Violence
Alcohol Abuse · IPV · Couples
Bottom Line
View on ClinicalTrials.gov: NCT05374798 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Heart Rate Variability During Alcohol-Facilitated Intimate Partner Violence (IPV) — 58.60; 62.28; 59.32; 60.15 Milliseconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Heart Rate Variability-Biofeedback (HRV-B) via Smartwatch Device Intervention (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Heart Rate Variability During Alcohol-Facilitated Intimate Partner Violence (IPV) |
58.60; 62.28; 59.32; 60.15 | — |
| PRIMARY Usability of Heart Rate Variability-Biofeedback Intervention |
51.6 | — |
| PRIMARY Feasibility of Heart Rate Variability-Biofeedback Intervention |
78; 21; 0 | — |
| PRIMARY Acceptability of Heart Rate Variability-Biofeedback Intervention |
24.6 | — |
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.
Eligibility Criteria
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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05374798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.