mHealth + Counseling for Alcoholism
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Florida
Disqualifiers: Psychiatric conditions, Alcohol withdrawal, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?In this project, the investigators will implement innovations to extend use of Contingency Management (CM) to facilitate alcohol use reduction among people living with HIV (PLWH). The investigators' approach to extending CM will use mobile health (mHealth) tools including a smartphone breathalyzer device with accompanying app and a wrist worn alcohol biosensor. Participants will be engaged in mobile facilitated CM for 30-60 days with follow-up out to 6 months.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on alcohol use reduction and does not mention any medication restrictions.
What data supports the effectiveness of this treatment for alcoholism?
Research shows that smartphone apps can help reduce alcohol consumption by providing real-time feedback and self-monitoring tools. In particular, studies have found that using a smartphone app alongside counseling can lead to significant reductions in drinking and its consequences.
12345Is the mHealth + Counseling treatment for alcoholism safe for humans?
The studies reviewed focus on the feasibility and acceptability of using mobile health tools and wearable devices for alcohol monitoring, but they do not report any specific safety concerns for humans.
12467How is the mHealth + Counseling treatment for alcoholism different from other treatments?
The mHealth + Counseling treatment for alcoholism is unique because it uses mobile health tools like smartphone apps and wearable devices to monitor alcohol use in real-time, providing immediate feedback to help reduce risky drinking behavior. This approach combines technology with counseling, offering a more interactive and accessible way to manage alcohol use compared to traditional in-person methods.
12348Eligibility Criteria
This trial is for people living with HIV who frequently drink heavily, are willing to try not drinking for at least 30 days, and then reduce their alcohol use. They must be comfortable using smartphone apps and a wrist sensor to monitor their drinking. Those with severe psychiatric conditions, current alcohol withdrawal symptoms, or recent intensive addiction treatment are excluded.Inclusion Criteria
Willingness to use smartphone applications and biosensor devices (i.e., breathalyzer device and wrist sensor) for alcohol use reduction purposes in the study. If participants do not have a compatible smartphone to use, they will be loaned one by the study
HIV positive
Fluency in English
+2 more
Exclusion Criteria
Currently seeking or past-12-month history of inpatient or intensive treatment for addictive behaviors
I am not pregnant, nursing, and I use reliable birth control.
Psychiatric conditions that would interfere with participation in the study
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment Phase 1
Participants engage in daily Contingency Management using a smartphone breathalyzer for 30 days
4 weeks
Daily virtual interactions
Treatment Phase 2
Participants engage in weekly Contingency Management using a wrist biosensor for an additional 30 days
4 weeks
Weekly virtual interactions
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
Periodic virtual check-ins
Participant Groups
The study tests mobile health tools—a smartphone breathalyzer app and a wrist-worn alcohol biosensor—to encourage less drinking among participants over a period of up to six months. The goal is to see if these mHealth innovations can help reduce alcohol consumption in individuals living with HIV.
3Treatment groups
Experimental Treatment
Group I: mHealth and CMExperimental Treatment2 Interventions
Participants will wear a wrist biosensor with daily CM based on smartphone breathalyzer readings for 30 days; then for a second 30 days, weekly CM based on wrist biosensor readings. Participants will also interact with a mobile health application to facilitate drinking reduction.
Group II: Non-Contingent ConditionExperimental Treatment1 Intervention
Participants will wear a wrist biosensor with daily CM based on smartphone breathalyzer readings for 30 days; then for a second 30 days, encouragement to reduce drinking but payment not based on drinking.
Group III: CMExperimental Treatment1 Intervention
Participants will wear a wrist biosensor with daily CM based on smartphone breathalyzer readings for 30 days; then for a second 30 days, weekly CM based on wrist biosensor readings
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of FloridaGainesville, FL
University of MiamiCoral Gables, FL
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Who Is Running the Clinical Trial?
University of FloridaLead Sponsor
Florida State UniversityCollaborator
University of MiamiCollaborator
University of LouisvilleCollaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator
References
User-centered preferences for a gait-informed alcohol intoxication app. [2023]mHealth technology can be used as a potential intervention for alcohol-related consequences. Applications designed to monitor alcohol use and relay information to the user may help to reduce risky behavior. Acceptability of such applications needs to be assessed.
Smartphone application for unhealthy alcohol use: A pilot study. [2022]Technology-delivered interventions are useful tools for addressing unhealthy alcohol use. Smartphones in particular offer opportunities to deliver interventions at the user's convenience. A smartphone application with 5 modules (personal feedback, self-monitoring of drinking, designated driver tool, blood alcohol content [BAC] calculator, information) was developed. Its acceptability and associations between use and drinking outcomes were assessed.
A combined laboratory and field test of a smartphone breath alcohol device and blood alcohol concentration estimator to facilitate moderate drinking among young adults. [2023]Innovative strategies are needed to reduce young adult drinking. Real-time feedback via mobile health (mHealth) technology (e.g., smartphone devices/apps) may facilitate moderate drinking, yet requires evidence of feasibility, acceptability, and usability.
Effectiveness of a Theory-Based mHealth Intervention for High-Risk Drinking in College Students. [2021]Background: College students are among the most vulnerable groups to problems associated with high-risk drinking consequences such as illness, injury, sexual abuse, and death. Promising mobile health (mHealth) approaches, such as smartphone (SP) apps, can be used in interventions to address or prevent excessive drinking. Method: The aim of the investigation was to examine the efficacy of a theoretically based mHealth SP app for alcohol intervention in two independent samples (N = 379): Mandated participants (Study 1) and voluntary participants (Study 2). Study 1 included a controlled trial with Mandated participants randomized into either an in-person Brief Motivational Interviewing BMI (n = 70) or BMI + SP app intervention (n = 71). Study 2 included Voluntary participants who participated in either a Control group (n = 157) or the BMI + SP app intervention (n = 81). Participants in both studies completed baseline and 6-week assessments. Results: In Study 1, peak Blood Alcohol Concentration (BAC) of participants in the in-person BMI group had increased slightly at six weeks, while it had decreased for the app-based BMI + SP group. Study 2 participants using the BMI + SP app reported significant reductions in drinking and consequences; there were no changes in the (AO) Control group. Conclusions: The BMI + SP app was effective with both Mandated and Voluntary participants. Future testing with the BMI + SP app is needed to assess whether reach, adoptability, portability, and sustainability are greater with the mHealth smartphone app for alcohol intervention than in-person approaches.
Smartphone applications to reduce alcohol consumption and help patients with alcohol use disorder: a state-of-the-art review. [2022]Hazardous drinking and alcohol use disorder (AUD) are substantial contributors to USA and global morbidity and mortality. Patient self-management and continuing care are needed to combat these public health threats. However, services are rarely provided to patients outside of clinic settings or following brief intervention. Smartphone applications ("apps") may help narrow the divide between traditional health care and patient needs. The purpose of this review is to identify and summarize smartphone apps to reduce alcohol consumption or treat AUD that have been evaluated for feasibility, acceptability, and/or efficacy. We searched two research databases for peer-reviewed journal articles published in English that evaluated smartphone apps to decrease alcohol consumption or treat AUD. We identified six apps. Two of these apps (A-CHESS and LBMI-A) promoted self-reported reductions in alcohol use, two (Promillekoll and PartyPlanner) failed to promote self-reported reductions in alcohol use, and two (HealthCall-S and Chimpshop) require further evaluation and testing before any conclusions regarding efficacy can be made. In summary, few evaluations of smartphone apps to reduce alcohol consumption or treat AUD have been reported in the scientific literature. Although advances in smartphone technology hold promise for disseminating interventions among hazardous drinkers and individuals with AUD, more systematic evaluations are necessary to ensure that smartphone apps are clinically useful.
Pilot Study of an Integrated Smartphone and Breathalyzer Contingency Management Intervention for Alcohol Use. [2022]Monitoring devices provide a platform for assessing alcohol use and implementing alcohol interventions. This pilot study focused on assessing the early-stage feasibility and usability of a smartphone-based application and breathalyzer used in a contingency management intervention for alcohol use.
Wearable alcohol monitors for alcohol use data collection among college students: Feasibility and acceptability. [2023]We assessed the feasibility and acceptability of using BACtrack Skyn wearable alcohol monitors for alcohol research in a college student population.
Preliminary Effectiveness of a Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality: Protocol for a Randomized Controlled Trial. [2022]Alcohol use disorder is a chronic disorder with a high likelihood of relapse. The consistent monitoring of blood alcohol concentration through breathalyzers is critical to identifying relapse or misuse. Smartphone apps as a replacement of or in conjunction with breathalyzers have shown limited effectiveness. Yet, there has been little research that has effectively utilized wireless or Wi-Fi-enabled breathalyzers that can accurately, securely, and reliably measure blood alcohol concentration.