Wearable Technology and Alcohol-Facilitated Intimate Partner Violence

Alcohol Abuse Clinical Trial

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Official title:

Using Wearable Technology to Develop Biomarker-Driven Intervention for Alcohol-Facilitated Intimate Partner Violence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05374798
• Other study ID #: Pro00116875
• Secondary ID: R21AA029235
• Status: Recruiting
• Phase: N/A
• Start date: January 27, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Medical University of South Carolina
• Contact: Stacey Sellers
• Phone: 843-792-5807
• Email: sellersst[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Couples
• IPV

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Addiction Sciences Division-Medical University of South Carolina	Charleston	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate Variability in Alcohol-Facilitated Intimate Partner Violence	Heart Rate Variability (HRV) is measured by Respiratory Sinus Arrhythmia taken using a Garmin smart watch.; We will examine associations between HRV and intimate partner violence (IPV).; HRV normalization following IPV will be calculated. Faster HRV normalization will represent better outcomes.	28 days
Primary	Intimate Partner Violence	We will examine associations between HRV and intimate partner violence (IPV).; Ecological momentary assessment (EMA) reports will be used to determine instances of IPV (self-report). Fewer instances of IPV represent better outcomes.	28 days
Primary	Usability of Heart Rate Variability-Biofeedback Intervention	Usability is assessed by the score on the self-report measure Post-Study System Usability Questionnaire (PSSUQ). A low score would indicate high usability of the Heart Rate Variability-Biofeedback (HRV-B) intervention, and a high score would indicate 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.	28 days
Primary	Feasibility of Heart Rate Variability-Biofeedback Intervention	Feasibility is assessed by the score on the self-report measure Website Analysis and Measurement Inventory (WAMMI). A low score would indicate high feasibility of the Heart Rate Variability-Biofeedback (HRV-B) intervention, and a high score would indicate low feasibility 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 WAMMI during their exit interview.	28 days
Primary	Acceptability of Heart Rate Variability-Biofeedback Intervention	Acceptability is assessed by the score on the self-report measure Client Satisfaction Questionnaire (CSQ). A high score would indicate high acceptability of the Heart Rate Variability-Biofeedback (HRV-B) intervention, and a low score would indicate 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.	28 days