Wearable Technology and Alcohol-Facilitated Intimate Partner Violence

NCT05374798 | Completed Results

• 2 other identifiers: Pro00116875R21AA029235
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Abuse; IPV; Couples

Outcome Measures

Primary Outcomes (4)

• Heart Rate Variability During Alcohol-Facilitated Intimate Partner Violence (IPV)

  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.

  From enrollment through end of evaluation period; 28 days.

• Usability of Heart Rate Variability-Biofeedback Intervention

  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.

  During the exit interview, following 28 days of ecological momentary assessment (EMA).

• Feasibility of Heart Rate Variability-Biofeedback Intervention

  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.

  From days 21-28 during the Heart Rate Variability-Biofeedback (HRV-B) intervention; 7 days.

• Acceptability of Heart Rate Variability-Biofeedback Intervention

  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.

  During the exit interview, following 28 days of ecological momentary assessment (EMA).

Study Arms (1)

Heart Rate Variability-Biofeedback via Smartwatch Device Intervention

EXPERIMENTAL

Participants will wear activity trackers equipped with continuous ambulatory physiological monitoring and geolocation. Ecological momentary assessment (EMA; 4 times daily plus optional event-triggered reports) of alcohol use, couple conflict including IPV, and affect will be completed via smartphone application for 28 days. During days 21-28, participants will also be prompted to complete a 10 minute self-administered HRV-B session at least once daily. Subjective usability, feasibility, and acceptability of HRV-B will be assessed.

Device: Heart Rate Variability-Biofeedback (HRV-B) via Smartwatch Device Intervention

Interventions

Heart Rate Variability-Biofeedback (HRV-B) via Smartwatch Device Intervention DEVICE

Participants will wear activity trackers equipped with continuous ambulatory physiological monitoring and geolocation. Ecological momentary assessment (EMA; 4 times daily plus optional event-triggered reports) of alcohol use, couple conflict including IPV, and affect will be completed via smartphone application for 28 days. During days 21-28, participants will also be prompted to complete a 10 minute self-administered HRV-B session at least once daily. Subjective usability, feasibility, and acceptability of HRV-B will be assessed. HRV-B will guide participants in an evidence-based paced breathing technique (about 6 breaths per minutes) using visualization on thier mobile device of thier real-time respiratory and cardiac parameters. During days 21-28, participants will also be prompted to complete a 10 minute self-administered HRV-B session at least once daily. Subjective usability, feasibility, and acceptability of HRV-B will be assessed.

Heart Rate Variability-Biofeedback via Smartwatch Device Intervention

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Addiction Sciences Division-Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Stacey sellers
• Organization: Medical University of South Carolina

sellersst@musc.edu

843-792-5807

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will wear activity trackers (Garmin smartwatch) equipped with continuous ambulatory physiological monitoring and geolocation. Ecological momentary assessment (EMA; 4 times daily plus optional event-triggered reports) of alcohol use, couple conflict including IPV, and affect will be completed via smartphone application for 28 days. During days 21-28, participants will also be prompted to complete a 10 minute self-administered HRV-B session at least once daily. Subjective usability, feasibility, and acceptability of HRV-B will be assessed The investigative team is not testing the Garmin smartwatch, but the use of EMA and HRV biofeedback as a mechanism to modulate alcohol use and IPV among couples.

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: May 16, 2022
• Study Start: January 27, 2023
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: July 14, 2025
• Results First Posted: July 14, 2025

Record last verified: 2025-07

Locations

US (1)