Wearable Technology and Alcohol-Facilitated Intimate Partner Violence

NCT ID: NCT05374798

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-27
• Study Completion Date: 2024-05-28

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.

Conditions

Alcohol Abuse; IPV; Couples

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Heart Rate Variability-Biofeedback via Smartwatch Device Intervention

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Julianne Flanagan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Addiction Sciences Division-Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R21AA029235

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00116875

Identifier Type: -

Identifier Source: org_study_id