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Behavioural Intervention

Smartwatch Biofeedback for Intimate Partner Violence (START Trial)

N/A

Recruiting

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

START Trial Summary

This trialis testing a smart watch and app to help couples reduce alcohol use and conflict, with a 28-day observation period to measure their progress.

Who is the study for?

This trial is for couples aged 21-70 where at least one partner has been involved in intimate partner violence (IPV) and meets criteria for alcohol use disorder (AUD). Participants must be fluent in English, mentally capable of consent, and have stable psychotropic medication if applicable. Couples should not have severe cardiovascular conditions, current pregnancy, acute alcohol withdrawal, suicidal or homicidal thoughts, certain medications affecting heart rate, severe brain injuries or unilateral IPV.Check my eligibility

What is being tested?

The study tests a smartwatch device with Heart Rate Variability-Biofeedback (HRV-B) and a cell phone app to see if they can help reduce alcohol consumption and conflict among couples. Over a period of 28 days, participants will wear the smartwatch to monitor their activities while using the app designed to support treatment.See study design

What are the potential side effects?

Since this intervention involves wearable technology rather than medication or invasive procedures, side effects are minimal but may include discomfort from wearing the device or stress from monitoring symptoms.

START Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I or my partner have been diagnosed with alcohol use disorder and have had multiple heavy drinking episodes recently.

START Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of Heart Rate Variability-Biofeedback Intervention

Feasibility of Heart Rate Variability-Biofeedback Intervention

Heart Rate Variability in Alcohol-Facilitated Intimate Partner Violence

+2 more

START Trial Design

1Treatment groups

Experimental Treatment

Group I: Heart Rate Variability-Biofeedback via Smartwatch Device InterventionExperimental Treatment1 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

933 Previous Clinical Trials

7,394,535 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,776 Total Patients Enrolled

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

802 Previous Clinical Trials

1,365,345 Total Patients Enrolled

Media Library

Heart Rate Variability Intervention (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05374798 — N/A

Couples Research Study Groups: Heart Rate Variability-Biofeedback via Smartwatch Device Intervention

Couples Clinical Trial 2023: Heart Rate Variability Intervention Highlights & Side Effects. Trial Name: NCT05374798 — N/A

Heart Rate Variability Intervention (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05374798 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities to enroll in this experiment currently?

"Affirmative. The clinicaltrials.gov page demonstrates that this research is seeking participants, with the trial first appearing on November 1st 2022 and updated most recently on November 10th 2022. One site has been identified for recruitment purposes in order to bring 100 individuals into the study."

Answered by AI

Does my profile qualify me to take part in this clinical research?

"This investigation is recruiting 100 individuals between the ages of 21 and 70 who have experienced intimate partner violence. Applicants must identify with any gender, racial/ethnic background, or sexual orientation; possess English fluency as well as cognitive ability signified by a score of 26+ on the Mini-Mental Status Exam (MMSE); have been taking psychotropic medication for at least 4 weeks prior to study commencement; report 2 hazardous drinking episodes per month in the past 3 months; demonstrate 1+ instance of IPV with current partner over last 6 months according to Revised Conflict Tactics Scale (CTS-2) criteria; and be married, co"

Answered by AI

How many participants have registered to take part in this experiment?

"Affirmative. Clinicaltrials.gov indicates that this medical trial, first posted on November 1st 2022, is still bringing in patients. The team needs to find 100 participants at a single site for the study's completion."

Answered by AI

Does this study allow for participants of any age, including those under 40?

"According to the study's entry requirements, the minimum age of permissible enrolment is 21 and the cap on a participant's age can be no higher than 70."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Wearable Technology and Alcohol-Facilitated Intimate Partner Violence

Julianne Flanagan 2023. "Wearable Technology and Alcohol-Facilitated Intimate Partner Violence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05374798.