Alcohol Abuse, Couples, IPV
Conditions
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.
Interventions
DEVICEHeart 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.
Sponsors
National Institutes of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate Variability During Alcohol-Facilitated Intimate Partner Violence (IPV) | From enrollment through end of evaluation period; 28 days. | 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. |
| Usability of Heart Rate Variability-Biofeedback Intervention | During the exit interview, following 28 days of ecological momentary assessment (EMA). | 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. |
| Feasibility of Heart Rate Variability-Biofeedback Intervention | From days 21-28 during the Heart Rate Variability-Biofeedback (HRV-B) intervention; 7 days. | 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. |
| Acceptability of Heart Rate Variability-Biofeedback Intervention | During the exit interview, following 28 days of ecological momentary assessment (EMA). | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 92 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 2 |
| Overall Study | Withdrawn by Principal Investigator. | 2 |
Baseline characteristics
| Characteristic | Full Sample |
|---|---|
| Age, Continuous Identified Patient | 37.0 years STANDARD_DEVIATION 10.1 |
| Age, Continuous Partner | 36.5 years STANDARD_DEVIATION 9.5 |
| Age, Continuous Total Sample | 36.8 years STANDARD_DEVIATION 9.7 |
| Ethnicity (NIH/OMB) Identified Patient Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Identified Patient Not Hispanic or Latino | 40 Participants |
| Ethnicity (NIH/OMB) Identified Patient Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) Partner Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Partner Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Partner Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) Total Sample Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Total Sample Not Hispanic or Latino | 81 Participants |
| Ethnicity (NIH/OMB) Total Sample Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Identified Patient American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Identified Patient Asian | 2 Participants |
| Race (NIH/OMB) Identified Patient Black or African American | 15 Participants |
| Race (NIH/OMB) Identified Patient More than one race | 4 Participants |
| Race (NIH/OMB) Identified Patient Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Identified Patient Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Identified Patient White | 23 Participants |
| Race (NIH/OMB) Partner American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Partner Asian | 2 Participants |
| Race (NIH/OMB) Partner Black or African American | 16 Participants |
| Race (NIH/OMB) Partner More than one race | 3 Participants |
| Race (NIH/OMB) Partner Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Partner Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Partner White | 25 Participants |
| Race (NIH/OMB) Total Sample American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Total Sample Asian | 4 Participants |
| Race (NIH/OMB) Total Sample Black or African American | 31 Participants |
| Race (NIH/OMB) Total Sample More than one race | 7 Participants |
| Race (NIH/OMB) Total Sample Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Total Sample Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Total Sample White | 48 Participants |
| Region of Enrollment United States | 92 participants |
| Sex: Female, Male Identified Patient Female | 22 Participants |
| Sex: Female, Male Identified Patient Male | 24 Participants |
| Sex: Female, Male Partner Female | 30 Participants |
| Sex: Female, Male Partner Male | 16 Participants |
| Sex: Female, Male Total Sample Female | 52 Participants |
| Sex: Female, Male Total Sample Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 92 |
| other Total, other adverse events | 0 / 92 |
| serious Total, serious adverse events | 0 / 92 |
Outcome results
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.
Time frame: During the exit interview, following 28 days of ecological momentary assessment (EMA).
Population: Analysis completed on 86 participants with valid self report and Heart Rate Variability-Biofeedback data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Full Sample | Acceptability of Heart Rate Variability-Biofeedback Intervention | 24.6 score on a scale | Standard Deviation 5.2 |
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.
Time frame: From days 21-28 during the Heart Rate Variability-Biofeedback (HRV-B) intervention; 7 days.
Population: Analysis completed on all 92 participants with Heart Rate Variability-Biofeedback data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Full Sample | Feasibility of Heart Rate Variability-Biofeedback Intervention | Completed intervention at least once | 78 Participants |
| Full Sample | Feasibility of Heart Rate Variability-Biofeedback Intervention | Completed intervention for at least 7 days | 21 Participants |
| Full Sample | Feasibility of Heart Rate Variability-Biofeedback Intervention | Completed 10 minutes of intervention for 7 days | 0 Participants |
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.
Time frame: From enrollment through end of evaluation period; 28 days.
Population: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Full Sample | Heart Rate Variability During Alcohol-Facilitated Intimate Partner Violence (IPV) | HRV/RSA Reports of Yes Alcohol and No Intimate Partner Violence (of 83 participants analyzed). | 59.32 Milliseconds | Standard Deviation 20.35 |
| Full Sample | Heart Rate Variability During Alcohol-Facilitated Intimate Partner Violence (IPV) | HRV/RSA Reports of Yes Alcohol and Yes Intimate Partner Violence (of 83 participants analyzed). | 60.15 Milliseconds | Standard Deviation 17.13 |
| Full Sample | Heart Rate Variability During Alcohol-Facilitated Intimate Partner Violence (IPV) | HRV/RSA Reports of No Alcohol and No Intimate Partner Violence (of 83 participants analyzed). | 58.60 Milliseconds | Standard Deviation 21.27 |
| Full Sample | Heart Rate Variability During Alcohol-Facilitated Intimate Partner Violence (IPV) | HRV/RSA Reports of No Alcohol and Yes Intimate Partner Violence (of 83 participants analyzed). | 62.28 Milliseconds | Standard Deviation 22.79 |
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.
Time frame: During the exit interview, following 28 days of ecological momentary assessment (EMA).
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Full Sample | Usability of Heart Rate Variability-Biofeedback Intervention | 51.6 score on a scale | Standard Deviation 23.7 |