Wearable Technology and Alcohol-Facilitated Intimate Partner Violence

Not Applicable

Completed

• Conditions: Alcohol Abuse; IPV; Couples

• Registration Number: NCT05374798
• Lead Sponsor: Medical University of South Carolina

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 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.

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 lifetimes. Recent data indicate that IPV negatively impacts AUD treatment and increases risk of relapse. Although behavioral treatments targeting AUD and IPV are effective for some women and men, efficacy is commonly limited by high dropout rates, poor working alliance, and low readiness to change. As a result, there is a critical and persistent need to develop dynamic treatment options to successfully reduce AUD and IPV concurrently.

Mitigating maladaptive physiological reactivity in the form of respiratory sinus arrhythmia measure of heart rate variability (HRV) is one promising pathway to achieve this goal. HRV is an autonomic biomarker of arousal relevant to AUD pathophysiology, alcohol consumption, and treatment outcomes. HRV is also an emerging mechanism underlying alcohol-facilitated IPV. Growing evidence suggests that biofeedback interventions to modulate physiological, emotional, and behavioral stress responses are feasible, acceptable, and may reduce AUD symptoms such as craving to improve long-term AUD recovery. This data suggests that remote, self-administered biofeedback interventions hold promise as a discreet, accessible and low cost standalone or adjunct treatment option for AUD patients with high risk behaviors such as IPV. Thus, the primary objective of the proposed project is to use wearable technology to develop proof-of-concept of HRV as a biomarker of alcohol-facilitated IPV in naturalistic settings. The secondary objective is to examine the preliminary usability, feasibility, and acceptability of a remote, self-administered HRV-B intervention.

Study Timeline

• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-05-10
• Study First Posted: 2022-05-16
• Study Start: 2023-01-27
• Primary Completion: 2024-05-28
• Study Completion: 2024-05-28
• Results First Submitted: 2025-05-13
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-10
• Last Update Submitted: 2025-07-10
• Results First Posted: 2025-07-14
• Last Update Posted: 2025-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

1. Any gender identity; any race or ethnicity; any sexual orientation; aged 21-70 years.
2. Married, cohabiting, or in a committed relationship for ≥ 6 months.
3. English fluency and cognitive functioning sufficient to provide informed consent and participate accurately (score ≥ 26 on the Mini-Mental Status Exam [MMSE]).
4. 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.
5. 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]).
6. Maintenance of psychotropic medications on a stable dose for at least 4 weeks before study initiation.

Exclusion Criteria

1. Meeting DSM-5 criteria for a history of or current psychotic or bipolar disorders.
2. 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.
3. Alcohol withdrawal as indicated by CIWA-Ar scores >8.
4. Current suicidal or homicidal ideation and intent.
5. Serious cardiovascular health conditions (e.g., pacemaker, cardiac arrhythmia, hypertension) because the safety of HRV-B has not yet been established in these populations.
6. Treatment on medications such as lithium, methadone, alpha or beta blockers or cholinergic/ anticholinergic medications likely to confound normative cardiovascular responding.
7. Current neurologic conditions or history of traumatic brain injury.
8. Severe and unilateral IPV in the past 6 months.
9. Current pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Heart Rate Variability During Alcohol-Facilitated Intimate Partner Violence (IPV)	From enrollment through end of evaluation period; 28 days.	Heart Rate Variability (HRV) was measured by Respiratory Sinus Arrhythmia (RSA) data derived from Garmin smart watch. RSA is a type/contributor of HRV that occurs when the heart rate changes with normal breathing (measure of changes in time in between heartbeats). RSA is an autonomic biomarker of arousal relevant to AUD pathophysiology. Alcohol-facilitated intimate partner violence (IPV) was measured by the self-reported presence of alcohol use, IPV or conflict on ecological momentary assessments (EMA; 4 times daily plus optional event-daily or event-driven) via a smartphone. HRV means were stratified by alcohol and IPV status at the prior report. Higher levels of HRV/Respiratory Sinus Arrhythmia represent better autonomic balance and physiological reactivity and low levels would represent more maladaptive physiological reactivity and autonomic imbalance.
Usability of Heart Rate Variability-Biofeedback Intervention	During the exit interview, following 28 days of ecological momentary assessment (EMA).	Usability is assessed by the score on the self-report Post-Study System Usability Questionnaire (PSSUQ), ranging from 18-126. A low score indicates high usability of the Heart Rate Variability-Biofeedback (HRV-B) intervention, and a high score indicates low usability of the HRV-B intervention. Participants explore the device/app for 28 days and add the biofeedback technique for the final 7 days. They are asked to complete the PSSUQ during their exit interview.
Feasibility of Heart Rate Variability-Biofeedback Intervention	From days 21-28 during the Heart Rate Variability-Biofeedback (HRV-B) intervention; 7 days.	Feasibility is assessed by the rates of Heart Rate Variability-Biofeedback (HRV-B) task completion over the final 7 days. Higher rates of completion would indicate high feasibility of the Heart Rate Variability-Biofeedback (HRV-B) intervention, and low rates of completion would indicate low feasibility of the HRV-B intervention.
Acceptability of Heart Rate Variability-Biofeedback Intervention	During the exit interview, following 28 days of ecological momentary assessment (EMA).	Acceptability is assessed by the score on the self-report measure Client Satisfaction Questionnaire (CSQ). Scores range from 8-32. A high score indicates high acceptability of the Heart Rate Variability-Biofeedback (HRV-B) intervention, and a low score indicates low acceptability of the HRV-B intervention. Participants explore the device/app for 28 days and add the biofeedback technique for the final 7 days. They are asked to complete the CSQ during their exit interview.

Trial Locations

Locations (1)

Addiction Sciences Division-Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States