Effectiveness of an Ecological Momentary Intervention for Reducing Risky Alcohol Consumption Among Young Adults: Protocol for a Three-Arm Randomized Controlled Trial.

Recent research has investigated the utility of mobile phone-delivered interventions for reducing risky single-occasion drinking, also known as binge drinking. In the past five years, focus has been placed on ecological momentary interventions (EMIs), which aim to deliver intervention content in correspondence to real-time assessments of behavior, also known as ecological momentary assessments (EMAs). This study aims to assess the effect of a fully automated, tailored, mobile phone-delivered EMI termed Mobile Intervention for Drinking in Young people (MIDY) on young people's risky single-occasion drinking behavior. We will use a three-armed randomized controlled trial design to determine the impact of MIDY on peak consumption of alcohol among young people. A list of mobile telephone numbers for random digit dialing will be generated, and researchers will telephone potential participants to screen for eligibility. Participants will be randomized into one of three intervention groups. For 6 weeks, EMI, EMA, and attention control groups will complete hourly EMA surveys on their mobile phones on Friday and Saturday nights. EMI participants will receive personalized feedback in the form of text messages corresponding to their EMA survey responses, which focus on alcohol consumption, spending, and mood. EMA participants will not receive feedback. A third group will also complete EMA and receive feedback text messages at the same time intervals, but these will be focused on sedentary behavior and technology use. All groups will also complete a short survey on Saturday and Sunday mornings, with the primary outcome measure taken on Sunday mornings. A more detailed survey will be sent on the final Sunday of the 6-week period, and then again 1 year after recruitment. The primary outcome measure will be an observed change (ie, reduction) in the mean peak number of drinks consumed in a single night over the 6-week intervention period between the EMI and attention control groups as measured in the weekly EMA. We expect to see a greater reduction in mean peak drinking in the EMI group compared to that in the attention control group. As a secondary aim, we will assess whether mean peak drinking is reduced in the EMA group compared to the attention control group. We will use a random-effects mixed-modeling approach using maximum-likelihood estimation to provide estimates of differences in peak drinking across time periods between those receiving the intervention (EMI) and attention control participants. An intention-to-treat approach will be taken for the analysis. Individuals and study groups will be modeled as random and fixed factors, respectively. This study extends our previous work investigating the efficacy of a mobile EMI (MIDY) for reducing risky drinking among young adults in Australia, and will add to the expanding literature on the use of mobile interventions for reducing risky alcohol consumption. Australian New Zealand Clinical Trials Registration (ANZCTR): ACTRN12617001509358p; http://www.anzctr.org.au/ACTRN12617001509358p.aspx. DERR1-10.2196/14190.

Wright C ，Dietze PM ，Kuntsche E ，Livingston M ，Agius PA ，Room R ，Raggatt M ，Hellard M ，Lim MSC ... -  《JMIR Research Protocols》

An Ecological Momentary Intervention to Reduce Alcohol Consumption in Young Adults Delivered During Drinking Events: Protocol for a Pilot Randomized Controlled Trial.

Risky drinking is a significant public health issue in young Australian adults. Brief interventions are one of few effective methods of reducing risky drinking but are time and cost intensive; innovative methods of delivery are therefore of interest. Mobile phones offer new opportunities to collect data and intervene during risky drinking events. Mobile phones have successfully been used for delivery of alcohol-related brief interventions and data collection but not in combination with or during drinking events. This pilot study will investigate the efficacy of an ecological momentary intervention (EMI), with combined ecological momentary assessment (EMA) and brief intervention delivered by mobile phones to young adults during risky drinking events. We will use a 3-armed randomized controlled trial to investigate the efficacy of the intervention for reducing peak single occasion drinking. Our sample is recruited from an observational cohort study of young, risky drinkers. Participants will be randomized into 1 of 3 intervention arms. On 6 nights across a 12-week study period, EMI and EMA groups will complete hourly EMA surveys on their mobile phone. EMI participants will receive tailored feedback short message service (SMS) texts corresponding to their EMA survey responses. The EMI participants will not receive feedback SMS. A third group will have no contact (no-contact control). All groups will then be contacted for a follow-up interview within 4 weeks of the 12-week study period ending. The primary outcome is mean reduction in standard drinks consumed during their most recent heavy drinking occasion as measured at follow-up. Secondary outcomes include alcohol consumption over the previous 6 months, experiences of alcohol-related harms, attitudes toward drinking and drunkenness, hazardous drinking and use of tobacco and illicit drugs. A random effects mixed modelling approach using maximum likelihood estimation will be used to provide estimates of differences in mean drinking levels between those receiving the intervention and control participants. This study is novel in that, unlike previous work, it will intervene repeatedly during single occasion drinking events. Further, it extends previous research in this area, which has applied limited tailoring of message content for SMS-based brief interventions. The findings of this study will contribute to the growing body of evidence to inform the use of mobile health interventions for reducing alcohol consumption and harms. Australian New Zealand Clinical Trials ACTRN12616001323415; https://www.anzctr.org.au/ Trial/Registration/TrialReview.aspx?id=369534 (Archived by WebCite at http://www.webcitation.org/ 6qDqBZV9b).

Wright CJ ，Dietze PM ，Agius PA ，Kuntsche E ，Room R ，Livingston M ，Hellard M ，Lim MS ... -  《JMIR Research Protocols》

Mobile Phone-Based Ecological Momentary Intervention to Reduce Young Adults' Alcohol Use in the Event: A Three-Armed Randomized Controlled Trial.

Real-time ecological momentary interventions have shown promising effects in domains other than alcohol use; however, only few studies regarding ecological momentary interventions for alcohol use have been conducted thus far. The increasing popularity of smartphones offers new avenues for intervention and innovation in data collection. We aimed to test the efficacy of an ecological momentary intervention, comprising mobile Web-based ecological momentary assessments (EMAs) and text messaging (short message service, SMS) brief interventions, delivered during drinking events using participants' mobile phones. We conducted a three-armed randomized controlled trial to assess the effect of a mobile Web-based ecological momentary assessment with texting feedback on self-reported alcohol consumption and alcohol-related harms in young adults. Participants were enrolled from an existing observational cohort study of young adults screened for risky drinking behavior. The intervention group (ecological momentary intervention group) completed repeated ecological momentary assessments during 6 drinking events and received immediate texting-based feedback in response to each ecological momentary assessment. The second group (ecological momentary assessment group) completed ecological momentary assessments without the brief intervention, and the third did not receive any contact during the trial period. Recent peak risky single-occasion drinking was assessed at the baseline and follow-up using telephone interviews. We used a random effects mixed modeling approach using maximum likelihood estimation to provide estimates of differences in mean drinking levels between groups between baseline and 12-week follow-up. A total of 269 participants were randomized into the 3 groups. The ecological momentary intervention group exhibited a small and nonsignificant increase between baseline and follow-up in (geometric) the mean number of standard drinks consumed at the most recent heavy drinking occasion (mean 12.5 vs 12.7). Both ecological momentary assessment and control groups exhibited a nonsignificant decrease (ecological momentary assessment: mean 13.8 vs 11.8; control: mean 12.3 vs 11.6); these changes did not differ significantly between groups (Wald χ22 1.6; P=.437) and the magnitude of the effects of the intervention were markedly small. No other significant differences between groups on measures of alcohol consumption or related harms were observed. The intervention acceptability was high despite the technical problems in delivery. With a small number of participants, this study showed few effects of an SMS-based brief intervention on peak risky single-occasion drinking. Nevertheless, the study highlights areas for further investigation into the effects of EMI on young adults with heavy alcohol consumption. Australian New Zealand Clinical Trials Registry ACTRN12616001323415; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369534 (Archived by WebCite at http://www.webcitation.org/7074mqwcs).

Wright C ，Dietze PM ，Agius PA ，Kuntsche E ，Livingston M ，Black OC ，Room R ，Hellard M ，Lim MS ... -  《JMIR mHealth and uHealth》

Effectiveness of a Combined Web-Based and Ecological Momentary Intervention for Incoming First-Year University Students: Protocol for a 3-Arm Randomized Controlled Trial.

Alcohol use among university students is common, and those who drink often choose to drink heavily (ie, 4 or more drinks per session for women or 5 or more for men). Web-based interventions (WBIs), in which students complete assessments and receive personalized feedback about their alcohol use, and ecological momentary interventions (EMIs), which use mobile devices as a method of delivering intervention information, are 2 methods that have had some success in reducing alcohol use among university students. The aim of this study was to investigate the effectiveness of a combined WBI and EMI intervention to reduce alcohol use among university students. The study is a 3-arm randomized controlled trial. Participants will be randomized into either a WBI+EMI condition, a WBI-only condition, or an assessment-only control. Our sample will consist of first-year university students, recruited through 5 residential colleges at the University of Otago, New Zealand. All participants will complete an online survey at baseline (ie, before Orientation Week); those in the WBI-only and WBI+EMI conditions will immediately receive personalized feedback (ie, the WBI), whereas participants in the assessment-only condition will receive no feedback. In addition, participants randomized into the WBI+EMI, but not those in the WBI-only or assessment-only groups, will receive 8 Orientation Week (2 per day on nights with large social events) and 6 academic year EMIs (delivered fortnightly). Participants in all conditions will complete brief surveys at the end of the first and second semester and report their weekend alcohol use fortnightly throughout each semester via ecological momentary assessments. The primary hypothesis is that participants in the WBI+EMI group will consume significantly fewer drinks during weekends in their first semester at university compared with WBI-only and assessment-only groups. Secondary hypotheses are that, when compared with the WBI-only and assessment-only groups, the WBI+EMI group will report consuming fewer drinks during Orientation Week, report experiencing fewer negative alcohol-related consequences after first semester, and report lower Alcohol Use Disorder Identification Test-Consumption scores following their first semester. This study adds to a growing body of work investigating the utility of WBIs and EMIs in curbing alcohol consumption. In addition, the study will help to inform policy approaches aimed at curbing alcohol consumption and alcohol-related harm in university students. Australian New Zealand Clinical Trials Registry ACTRN12618000015246; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374104&isReview=true (Archived by WebCite at http://www.webcitation.org/6z9jRLTz6). RR1-10.2196/10164.

Riordan BC ，Moradi S ，Carey KB ，Conner TS ，Jang K ，Reid KE ，Scarf D ... -  《JMIR Research Protocols》

Combined Motivational Interviewing and Ecological Momentary Intervention to Reduce Hazardous Alcohol Use Among Sexual Minority Cisgender Men and Transgender Individuals: Protocol for a Randomized Controlled Trial.

Sexual minority cisgender men and transgender (SMMT) individuals, particularly emerging adults (aged 18-34 years), often report hazardous drinking. Given that alcohol use increases the likelihood of HIV risk behaviors, and HIV disproportionately affects SMMT individuals, there is a need to test interventions that reduce hazardous alcohol use and subsequent HIV risk behaviors among this population. Ecological momentary interventions (EMIs), which use mobile phones to deliver risk reduction messages based on current location and behaviors, can help to address triggers that lead to drinking in real time. This study will test an EMI that uses motivational interviewing (MI), smartphone surveys, mobile breathalyzers, and location tracking to provide real-time messaging that addresses triggers for drinking when SMMT individuals visit locations associated with hazardous alcohol use. In addition, the intervention will deliver harm reduction messaging if individuals report engaging in alcohol use. We will conduct a 3-arm randomized controlled trial (N=405 HIV-negative SMMT individuals; n=135, 33% per arm) comparing the following conditions: (1) Tracking and Reducing Alcohol Consumption (a smartphone-delivered 4-session MI intervention), (2) Tracking and Reducing Alcohol Consumption and Environmental Risk (an EMI combining MI with real-time messaging based on geographic locations that are triggers to drinking), and (3) a smartphone-based alcohol monitoring-only control group. Breathalyzer results and daily self-reports will be used to assess the primary and secondary outcomes of drinking days, drinks per drinking day, binge drinking episodes, and HIV risk behaviors. Additional assessments at baseline, 3 months, 6 months, and 9 months will evaluate exploratory long-term outcomes. The study is part of a 5-year research project funded in August 2022 by the National Institute on Alcohol Abuse and Alcoholism. The first 1.5 years of the study will be dedicated to planning and development activities, including formative research, app design and testing, and message design and testing. The subsequent 3.5 years will see the study complete participant recruitment, data collection, analyses, report writing, and dissemination. We expect to complete all study data collection in or before January 2027. This study will provide novel evidence about the relative efficacy of using a smartphone-delivered MI intervention and real-time messaging to address triggers for hazardous alcohol use and sexual risk behaviors. The EMI approach, which incorporates location-based preventive messaging and behavior surveys, may help to better understand the complexity of daily stressors among SMMT individuals and their impact on hazardous alcohol use and HIV risk behaviors. The tailoring of this intervention toward SMMT individuals helps to address their underrepresentation in existing alcohol use research and will be promising for informing where structural alcohol use prevention and treatment interventions are needed to support SMMT individuals. ClinicalTrials.gov NCT05576350; https://www.clinicaltrials.gov/study/NCT05576350. PRR1-10.2196/55166.

Lauckner C ，Takenaka BP ，Sesenu F ，Brown JS ，Kirklewski SJ ，Nicholson E ，Haney K ，Adatorwovor R ，Boyd DT ，Fallin-Bennett K ，Restar AJ ，Kershaw T ... -  《JMIR Research Protocols》