Trial Outcomes & Findings for Wearable Technology and Alcohol-Facilitated Intimate Partner Violence (NCT NCT05374798)
NCT ID: NCT05374798
Last Updated: 2025-07-14
Results Overview
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.
COMPLETED
NA
92 participants
From enrollment through end of evaluation period; 28 days.
2025-07-14
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
92
|
|
Overall Study
COMPLETED
|
86
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Withdrawn by Principal Investigator.
|
2
|
Baseline Characteristics
Identified Patient and Partner listed in individual rows.
Baseline characteristics by cohort
| Measure |
Full Sample
n=92 Participants
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.
|
|---|---|
|
Age, Continuous
Total Sample
|
36.8 years
STANDARD_DEVIATION 9.7 • n=92 Participants • Identified Patient and Partner listed in individual rows.
|
|
Age, Continuous
Identified Patient
|
37.0 years
STANDARD_DEVIATION 10.1 • n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Age, Continuous
Partner
|
36.5 years
STANDARD_DEVIATION 9.5 • n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Sex: Female, Male
Total Sample · Female
|
52 Participants
n=92 Participants • Identified Patient and Partner listed in individual rows.
|
|
Sex: Female, Male
Total Sample · Male
|
40 Participants
n=92 Participants • Identified Patient and Partner listed in individual rows.
|
|
Sex: Female, Male
Identified Patient · Female
|
22 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Sex: Female, Male
Identified Patient · Male
|
24 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Sex: Female, Male
Partner · Female
|
30 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Sex: Female, Male
Partner · Male
|
16 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Ethnicity (NIH/OMB)
Total Sample · Hispanic or Latino
|
11 Participants
n=92 Participants • Identified Patient and Partner listed in individual rows.
|
|
Ethnicity (NIH/OMB)
Total Sample · Not Hispanic or Latino
|
81 Participants
n=92 Participants • Identified Patient and Partner listed in individual rows.
|
|
Ethnicity (NIH/OMB)
Total Sample · Unknown or Not Reported
|
0 Participants
n=92 Participants • Identified Patient and Partner listed in individual rows.
|
|
Ethnicity (NIH/OMB)
Identified Patient · Hispanic or Latino
|
6 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Ethnicity (NIH/OMB)
Identified Patient · Not Hispanic or Latino
|
40 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Ethnicity (NIH/OMB)
Identified Patient · Unknown or Not Reported
|
0 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Ethnicity (NIH/OMB)
Partner · Hispanic or Latino
|
5 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Ethnicity (NIH/OMB)
Partner · Not Hispanic or Latino
|
41 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Ethnicity (NIH/OMB)
Partner · Unknown or Not Reported
|
0 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Race (NIH/OMB)
Total Sample · American Indian or Alaska Native
|
1 Participants
n=92 Participants • Identified Patient and Partner listed in individual rows.
|
|
Race (NIH/OMB)
Total Sample · Asian
|
4 Participants
n=92 Participants • Identified Patient and Partner listed in individual rows.
|
|
Race (NIH/OMB)
Total Sample · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=92 Participants • Identified Patient and Partner listed in individual rows.
|
|
Race (NIH/OMB)
Total Sample · Black or African American
|
31 Participants
n=92 Participants • Identified Patient and Partner listed in individual rows.
|
|
Race (NIH/OMB)
Total Sample · White
|
48 Participants
n=92 Participants • Identified Patient and Partner listed in individual rows.
|
|
Race (NIH/OMB)
Total Sample · More than one race
|
7 Participants
n=92 Participants • Identified Patient and Partner listed in individual rows.
|
|
Race (NIH/OMB)
Total Sample · Unknown or Not Reported
|
0 Participants
n=92 Participants • Identified Patient and Partner listed in individual rows.
|
|
Race (NIH/OMB)
Identified Patient · American Indian or Alaska Native
|
1 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Race (NIH/OMB)
Identified Patient · Asian
|
2 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Race (NIH/OMB)
Identified Patient · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Race (NIH/OMB)
Identified Patient · Black or African American
|
15 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Race (NIH/OMB)
Identified Patient · White
|
23 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Race (NIH/OMB)
Identified Patient · More than one race
|
4 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Race (NIH/OMB)
Identified Patient · Unknown or Not Reported
|
0 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Race (NIH/OMB)
Partner · American Indian or Alaska Native
|
0 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Race (NIH/OMB)
Partner · Asian
|
2 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Race (NIH/OMB)
Partner · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Race (NIH/OMB)
Partner · Black or African American
|
16 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Race (NIH/OMB)
Partner · White
|
25 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Race (NIH/OMB)
Partner · More than one race
|
3 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Race (NIH/OMB)
Partner · Unknown or Not Reported
|
0 Participants
n=46 Participants • Identified Patient and Partner listed in individual rows.
|
|
Region of Enrollment
United States
|
92 participants
n=92 Participants
|
PRIMARY outcome
Timeframe: 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)
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.
Outcome measures
| Measure |
Full Sample
n=83 Participants
Participants were N=46 couples 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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Full Sample
n=85 Participants
Participants were N=46 couples 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.
|
|---|---|
|
Usability of Heart Rate Variability-Biofeedback Intervention
|
51.6 score on a scale
Standard Deviation 23.7
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Full Sample
n=92 Participants
Participants were N=46 couples 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.
|
|---|---|
|
Feasibility of Heart Rate Variability-Biofeedback Intervention
Completed intervention at least once
|
78 Participants
|
|
Feasibility of Heart Rate Variability-Biofeedback Intervention
Completed intervention for at least 7 days
|
21 Participants
|
|
Feasibility of Heart Rate Variability-Biofeedback Intervention
Completed 10 minutes of intervention for 7 days
|
0 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Full Sample
n=86 Participants
Participants were N=46 couples 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.
|
|---|---|
|
Acceptability of Heart Rate Variability-Biofeedback Intervention
|
24.6 score on a scale
Standard Deviation 5.2
|
Adverse Events
Total Sample
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place