Alcohol AbuseSTARTNCT05374798
Wearable Technology and Alcohol-Facilitated Intimate Partner Violence
A study testing Heart Rate Variability-Biofeedback (HRV-B) via Smartwatch Device Intervention in people with Alcohol Abuse and IPV, run by Medical University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Alcohol Abuse, IPV, Couples
- What is being tested?
- Heart Rate Variability-Biofeedback (HRV-B) via Smartwatch Device Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2023to 28 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any gender identity; any race or ethnicity; any sexual orientation; aged 21-70 years.
- Married, cohabiting, or in a committed relationship for ≥ 6 months.
- English fluency and cognitive functioning sufficient to provide informed consent and participate accurately (score ≥ 26 on the Mini-Mental Status Exam [MMSE]).
- 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.
- 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]).
- Maintenance of psychotropic medications on a stable dose for at least 4 weeks before study initiation.
Who cannot join
- Meeting DSM-5 criteria for a history of or current psychotic or bipolar disorders.
- 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.
- Alcohol withdrawal as indicated by CIWA-Ar scores >8.
- Current suicidal or homicidal ideation and intent.
- Serious cardiovascular health conditions (e.g., pacemaker, cardiac arrhythmia, hypertension) because the safety of HRV-B has not yet been established in these populations.
- Treatment on medications such as lithium, methadone, alpha or beta blockers or cholinergic/ anticholinergic medications likely to confound normative cardiovascular responding.
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- Current neurologic conditions or history of traumatic brain injury.
- Severe and unilateral IPV in the past 6 months.
- Current pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Addiction Sciences Division-Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Using Wearable Technology to Develop Biomarker-Driven Intervention for Alcohol-Facilitated Intimate Partner Violence
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.
Read the 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.
- Conditions
- Alcohol Abuse, IPV, Couples
- Being tested
- Heart Rate Variability-Biofeedback (HRV-B) via Smartwatch Device Intervention
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Rate Variability-Biofeedback (HRV-B) via Smartwatch Device InterventionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Heart Rate Variability-Biofeedback (HRV-B) via Smartwatch Device Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From days 21-28 during the Heart Rate Variability-Biofeedback (HRV-B) intervention; 7 days.
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.
Measured: During the exit interview, following 28 days of ecological momentary assessment (EMA).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start27 Jan 2023
- Primary completion28 May 2024
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Julianne Flanagan, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374798
- Sponsor's protocol ID
- Pro00116875
- Other IDs
- R21AA029235
- Acronym
- START
- Status last verified
- Jul 2025
- First submitted
- 14 Apr 2022
- Last updated
- 14 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Wearable Technology to Develop Biomarker-Driven Intervention for Alcohol-Facilitated Intimate Partner Violence
- ClinicalTrials.gov ID
- NCT05374798
- Acronym / sponsor ID
- START / Pro00116875
- Conditions
- Alcohol Abuse, IPV, Couples
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 16 May 2022 (actual)
- Results
- Posted 14 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Heart Rate Variability-Biofeedback via Smartwatch Device Intervention | Experimental | Device: Heart Rate Variability-Biofeedback (HRV-B) via Smartwatch Device InterventionParticipants 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. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Any gender identity; any race or ethnicity; any sexual orientation; aged 21-70 years.
- Married, cohabiting, or in a committed relationship for ≥ 6 months.
- English fluency and cognitive functioning sufficient to provide informed consent and participate accurately (score ≥ 26 on the Mini-Mental Status Exam [MMSE]).
- 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.
- 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]).
Key exclusion criteria (9 listed)
- Meeting DSM-5 criteria for a history of or current psychotic or bipolar disorders.
- 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.
- Alcohol withdrawal as indicated by CIWA-Ar scores >8.
- Current suicidal or homicidal ideation and intent.
- Serious cardiovascular health conditions (e.g., pacemaker, cardiac arrhythmia, hypertension) because the safety of HRV-B has not yet been established in these populations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart Rate Variability-Biofeedback (HRV-B) via Smartwatch Device InterventionParticipants 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. | Device | Heart Rate Variability-Biofeedback via Smartwatch Device Intervention |
Primary outcome
Heart Rate Variability During Alcohol-Facilitated Intimate Partner Violence (IPV)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Rate Variability-Biofeedback (HRV-B) via Smartwatch Device Intervention in people with Alcohol Abuse and IPV, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability During Alcohol-Facilitated Intimate Partner Violence (IPV) (time frame: From enrollment through end of evaluation period; 28 days.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.