Alcohol Abuse Clinical Trial
— STARTOfficial title:
Using Wearable Technology to Develop Biomarker-Driven Intervention for Alcohol-Facilitated Intimate Partner Violence
Verified date | June 2024 |
Source | Medical University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 92 |
Est. completion date | May 28, 2025 |
Est. primary completion date | May 28, 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. |
Country | Name | City | State |
---|---|---|---|
United States | Addiction Sciences Division-Medical University of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina | National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH) |
United States,
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 |
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