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Wearable Technology and Alcohol-Facilitated Intimate Partner Violence (START)

Primary Purpose

Alcohol Abuse, IPV, Couples

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heart Rate Variability-Biofeedback (HRV-B) via Smartwatch Device Intervention
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol Abuse

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Addiction Sciences Division-Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Heart Rate Variability-Biofeedback via Smartwatch Device Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Heart Rate Variability in Alcohol-Facilitated Intimate Partner Violence
Heart Rate Variability (HRV) is measured by Respiratory Sinus Arrhythmia taken using a Garmin smart watch. We will examine associations between HRV and intimate partner violence (IPV). HRV normalization following IPV will be calculated. Faster HRV normalization will represent better outcomes.
Intimate Partner Violence
We will examine associations between HRV and intimate partner violence (IPV). Ecological momentary assessment (EMA) reports will be used to determine instances of IPV (self-report). Fewer instances of IPV represent better outcomes.
Usability of Heart Rate Variability-Biofeedback Intervention
Usability is assessed by the score on the self-report measure Post-Study System Usability Questionnaire (PSSUQ). A low score would indicate high usability of the Heart Rate Variability-Biofeedback (HRV-B) intervention, and a high score would indicate 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
Feasibility is assessed by the score on the self-report measure Website Analysis and Measurement Inventory (WAMMI). A low score would indicate high feasibility of the Heart Rate Variability-Biofeedback (HRV-B) intervention, and a high score would indicate low feasibility 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 WAMMI during their exit interview.
Acceptability of Heart Rate Variability-Biofeedback Intervention
Acceptability is assessed by the score on the self-report measure Client Satisfaction Questionnaire (CSQ). A high score would indicate high acceptability of the Heart Rate Variability-Biofeedback (HRV-B) intervention, and a low score would indicate 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.

Secondary Outcome Measures

Full Information

First Posted
April 14, 2022
Last Updated
March 8, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05374798
Brief Title
Wearable Technology and Alcohol-Facilitated Intimate Partner Violence
Acronym
START
Official Title
Using Wearable Technology to Develop Biomarker-Driven Intervention for Alcohol-Facilitated Intimate Partner Violence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 27, 2023 (Actual)
Primary Completion Date
March 29, 2024 (Anticipated)
Study Completion Date
March 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, IPV, Couples

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heart Rate Variability-Biofeedback via Smartwatch Device Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Heart Rate Variability-Biofeedback (HRV-B) via Smartwatch Device Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Heart Rate Variability in Alcohol-Facilitated Intimate Partner Violence
Description
Heart Rate Variability (HRV) is measured by Respiratory Sinus Arrhythmia taken using a Garmin smart watch. We will examine associations between HRV and intimate partner violence (IPV). HRV normalization following IPV will be calculated. Faster HRV normalization will represent better outcomes.
Time Frame
28 days
Title
Intimate Partner Violence
Description
We will examine associations between HRV and intimate partner violence (IPV). Ecological momentary assessment (EMA) reports will be used to determine instances of IPV (self-report). Fewer instances of IPV represent better outcomes.
Time Frame
28 days
Title
Usability of Heart Rate Variability-Biofeedback Intervention
Description
Usability is assessed by the score on the self-report measure Post-Study System Usability Questionnaire (PSSUQ). A low score would indicate high usability of the Heart Rate Variability-Biofeedback (HRV-B) intervention, and a high score would indicate 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
28 days
Title
Feasibility of Heart Rate Variability-Biofeedback Intervention
Description
Feasibility is assessed by the score on the self-report measure Website Analysis and Measurement Inventory (WAMMI). A low score would indicate high feasibility of the Heart Rate Variability-Biofeedback (HRV-B) intervention, and a high score would indicate low feasibility 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 WAMMI during their exit interview.
Time Frame
28 days
Title
Acceptability of Heart Rate Variability-Biofeedback Intervention
Description
Acceptability is assessed by the score on the self-report measure Client Satisfaction Questionnaire (CSQ). A high score would indicate high acceptability of the Heart Rate Variability-Biofeedback (HRV-B) intervention, and a low score would indicate 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
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Current neurologic conditions or history of traumatic brain injury. Severe and unilateral IPV in the past 6 months. Current pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stacey Sellers
Phone
843-792-5807
Email
sellersst@musc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Julianne Flanagan
Email
hellmuth@musc.edu
Facility Information:
Facility Name
Addiction Sciences Division-Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacey Sellers, MS
Email
backs@musc.edu
First Name & Middle Initial & Last Name & Degree
Kori swanson
Phone
8437927048
Email
swansoko@musc.edu
First Name & Middle Initial & Last Name & Degree
Julianne Flanagan, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Wearable Technology and Alcohol-Facilitated Intimate Partner Violence

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