Alcohol Abuse Clinical Trial
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03165942 -
Neuroendocrine Response to Oral Alcohol Administration
|
Phase 1 | |
Recruiting |
NCT05343039 -
Technology Enhanced Adolescent Mental Health (TEAM)
|
N/A | |
Active, not recruiting |
NCT04070521 -
EEG Monitoring in the Emergency Department
|
||
Completed |
NCT03169244 -
Buproprion for Binge Drinking
|
Phase 2 | |
Recruiting |
NCT05246202 -
Personalized Feedback Intervention for Latinx Drinkers With Anxiety
|
N/A | |
Completed |
NCT05036499 -
PFI for Pain-Related Anxiety Among Hazardous Drinkers With Chronic Pain
|
N/A | |
Recruiting |
NCT04368416 -
Anxiety/Depression, Sleep and Alcohol in Elderly Anxiety/Depression, Sleep Disturbances and Alcohol Use Disorder in Elderly With Cognitive Complaints
|
||
Not yet recruiting |
NCT04557631 -
Evaluation of the Threshold for the Interpretation of the Results of a Method for the Blood Determination of Phosphatidyléthanol
|
||
Terminated |
NCT00890149 -
Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults
|
Phase 2 | |
Completed |
NCT02681406 -
Smartphone Based Continuing Care for Alcohol
|
N/A | |
Completed |
NCT02179749 -
Mifepristone Treatment of Alcohol Use Disorder
|
Phase 2 | |
Completed |
NCT02448134 -
A Community-Based Strategy for Preventing Underage Drinking
|
N/A | |
Withdrawn |
NCT01796158 -
Pilot Test of Computerized MET to Reduce Adolescent Alcohol Use
|
N/A | |
Withdrawn |
NCT01847300 -
cSBI-M for Young Military Personnel
|
N/A | |
Terminated |
NCT01408641 -
Topiramate for Alcohol Use in Posttraumatic Stress Disorder
|
N/A | |
Completed |
NCT01553136 -
Varenicline Treatment of Alcohol Dependence in Smokers
|
Phase 2 | |
Withdrawn |
NCT01511679 -
Brain-imaging and Adolescent Neuroscience Consortium
|
N/A | |
Withdrawn |
NCT01275391 -
cSBIRT to Reduce Teen Tobacco, Alcohol and Drug Use
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT01539525 -
Screening to Augment Referral to Treatment- Project START
|
Phase 2 | |
Completed |
NCT00907309 -
Dental and Medical Office iMET to Reduce Teen Tobacco, Alcohol, and Drug Use
|
Phase 1/Phase 2 |