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| ID | Type | Description | Link |
|---|---|---|---|
| R21AA029235 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Addiction Sciences Division-Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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Participants were N=46 couples (N=92 individuals) where at least one partner within each dyad must have 1) met Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria for current alcohol use disorder and current alcohol use, and 2) have reported at least one instance of physical intimate partner violence in the past two years.
Participants were recruited through internet advertisements, clinician referrals and community providers, flyers, and from prior research studies. Following preliminary eligibility screening, couples completed private written informed consent and a baseline assessment separately for privacy. The baseline assessment included a alcohol and drug screen, battery of standardized self-report and interview measures. Recruitment and enrollment occurred from November 2022 through April 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Full Sample | Participants were N=46 couples (N=92 individuals) with current alcohol use disorder and recent physical intimate partner violence (IPV). All participants completed 28 days of ecological momentary assessment (EMA) (4 times daily plus optional event-driven reports) of alcohol use, couple conflict including IPV, and affect via smartphone. |
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| Overall Study |
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The full sample consists of N=92 participants. Outcome measures were collected and reported on N=86 participants (2 participants dropped out, 2 participants were lost to follow up and 2 participants were withdrawn by Principal Investigator).
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| ID | Title | Description |
|---|---|---|
| BG000 | Full Sample | Participants were N=46 couples with current alcohol use disorder (AUD) and recent physical intimate partner violence (IPV). All participants completed 28 days of ecological momentary assessment (EMA); 4 times daily plus optional event-driven reports) of alcohol use, couple conflict including IPV, and affect via smartphone. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Identified Patient and Partner listed in individual rows. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis completed on N=83 participants who had at least one valid Heart Rate Variability measurement. N=9 participant were not included in the sample. N=2 lost to follow up. N=2 withdrew from the study. N=2 withdrawn by principal investigator. N=3 heart rate variability was not collected. The means below represent instances where reports were generated in each condition (e.g. HRV diary report when responder indicated no alcohol and no IPV) | Posted | Mean | Standard Deviation | Milliseconds | From enrollment through end of evaluation period; 28 days. |
Adverse events were collected throughout the course of the study (from baseline through the 28 day assessment period and the exit interview).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Total Sample | Participants were N=46 couples with current AUD and recent physical IPV. All participants completed 28 days of ecological momentary assessment (EMA; 4 times daily plus optional event-driven reports) of alcohol use, couple conflict including IPV, and affect via smartphone. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stacey sellers | Medical University of South Carolina | 843-792-5807 | sellersst@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2024 | May 12, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 28, 2024 | Jun 4, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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.
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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). |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Identified Patient and Partner listed in individual rows. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Identified Patient and Partner listed in individual rows. | Count of Participants | Participants |
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| Race (NIH/OMB) | Identified Patient and Partner listed in individual rows. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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. | Participants analyzed include all participants who completed the Post-Study System Usability Questionnaire. Although N=86 participants completed the PSSUQ, one person responded with 'N/A' to all of the questions, thus creating an invalid response. Data was analyzed on N=85 participants. | Posted | Mean | Standard Deviation | score on a scale | During the exit interview, following 28 days of ecological momentary assessment (EMA). |
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| Primary | 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. | Analysis completed on all 92 participants with Heart Rate Variability-Biofeedback data. | Posted | Count of Participants | Participants | From days 21-28 during the Heart Rate Variability-Biofeedback (HRV-B) intervention; 7 days. |
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| Primary | 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. | Analysis completed on 86 participants with valid self report and Heart Rate Variability-Biofeedback data. | Posted | Mean | Standard Deviation | score on a scale | During the exit interview, following 28 days of ecological momentary assessment (EMA). |
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| 0 |
| 92 |
| 0 |
| 92 |
| 0 |
| 92 |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
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