Dataset Information

A Multimodal Mobile Sleep Intervention for Young Adults Engaged in Risky Drinking: Protocol for a Randomized Controlled Trial.

ABSTRACT:

Background

This paper describes the research protocol for a randomized controlled trial of a multimodal mobile sleep intervention for heavy-drinking young adults. Young adults report the highest rates of heavy, risky alcohol consumption and are a priority population for alcohol prevention and intervention efforts. Alcohol strategies that leverage other health concerns and use technology may offer an innovative solution. Poor sleep is common among young adults and is a risk factor for developing an alcohol use disorder. Moreover, young adults are interested in information to help them sleep better, and behavioral sleep interventions address alcohol use as a standard practice.

Objective

The primary aim of this study is to assess the effectiveness of a 2-week multimodal mobile sleep intervention for reducing drinks consumed per week among heavy-drinking young adults. We will explore the effects on alcohol-related consequences, assessing quantitative and qualitative sleep characteristics as secondary aims. The study's goals are to identify the optimal combination of sleep intervention components for improving drinking outcomes, the feasibility and acceptability of these components, and the potential mechanisms by which these components may promote alcohol behavior change.

Methods

Young adults (aged 18-25 years) who report recent heavy drinking will be randomly assigned to one of three conditions: mobile sleep hygiene advice (n=30), mobile sleep hygiene advice and sleep and alcohol diary self-monitoring (n=30), or mobile sleep hygiene advice, sleep and alcohol diary self-monitoring, and sleep and alcohol data feedback (n=60). For the feedback component, participants will complete two web-based sessions with a health coach during which they will receive summaries of their sleep and alcohol data, and the potential association between them along with brief advice tailored to their data. All participants will wear sleep and alcohol biosensors daily for 2 weeks for objective assessments of these outcomes.

Results

The study was funded by the National Institutes of Health in May 2018. Recruitment began in December 2018 and will be concluded in Spring 2021. As of February 4, 2021, we have enrolled 110 participants.

Conclusions

Ultimately, this research could result in an efficacious, low-cost intervention with broad population reach through the use of technology. In addition, this intervention may substantially impact public health by reducing alcohol use disorder risk at a crucial developmental stage.

Trial registration

ClinicalTrials.gov NCT03658954; https://clinicaltrials.gov/ct2/show/NCT03658954.

International registered report identifier (irrid)

DERR1-10.2196/26557.

SUBMITTER: Fucito LM

PROVIDER: S-EPMC7954653 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A Multimodal Mobile Sleep Intervention for Young Adults Engaged in Risky Drinking: Protocol for a Randomized Controlled Trial.

Fucito Lisa M LM Ash Garrett I GI DeMartini Kelly S KS Pittman Brian B Barnett Nancy P NP Li Chiang-Shan R CR Redeker Nancy S NS O'Malley Stephanie S SS

JMIR research protocols 20210226 2

<h4>Background</h4>This paper describes the research protocol for a randomized controlled trial of a multimodal mobile sleep intervention for heavy-drinking young adults. Young adults report the highest rates of heavy, risky alcohol consumption and are a priority population for alcohol prevention and intervention efforts. Alcohol strategies that leverage other health concerns and use technology may offer an innovative solution. Poor sleep is common among young adults and is a risk factor for dev ...[more]

PMID: 33635276

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Project description:BackgroundYoung adults' drinking habits commonly exceed recommendations for low-risk drinking, which may have a negative effect on their mental, social, and physical health. As smartphones are highly accessible to young adults, mobile apps could be used to support young adults to develop low-risk drinking habits and improve their general health.ObjectiveThe objective of this study is to evaluate the effectiveness of Boozebuster, a self-guided mobile app based on healthy lifestyle-related components that aim to develop and maintain low-risk drinking habits among young adults.MethodsThis two-arm, parallel-group randomized controlled trial will investigate whether a 6-week self-guided mobile intervention (Boozebuster) targeting drinking behavior is more effective than a minimal intervention consisting of an educational website on alcohol use and its consequences for young adults. We will recruit 506 young adults (aged 18-30 years) from the Netherlands via an open recruitment strategy by using an open access website. All outcomes will be self-assessed through questionnaires. The primary outcome is the quantity and frequency of alcohol consumption in standard drinks (10 g ethanol per standard drink) per month (timeline follow-back [TLFB]). Secondary outcomes include binge-drinking sessions per month, alcohol-related problem severity (Rutgers Alcohol Problem Index), cannabis use frequency and quantity in grams (TLFB), depressive symptoms (Center for Epidemiological Studies Depression Scale), perceived stress (Perceived Stress Scale), engagement (Twente Engagement with eHealth Technologies Scale), readiness to change (Readiness to Change Questionnaire), mental well-being (Warwick-Edinburgh Mental Wellbeing Scale), trauma and COVID-19-related trauma (Short-Form Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition), impulsivity (Urgency, Premeditation, Perseverance, Sensation Seeking, Positive Urgency Impulsive Behavior Scale), study or work performance (Individual Work Performance Questionnaire), and treatment adherence. Baseline (T0), 6-week postbaseline (T1), and 3-month postbaseline (T2) assessments will be conducted and analyzed on the basis of the intention-to-treat principle using multilevel mixed modeling analyses.ResultsRecruitment began in September 2020. We received 933 registrations via our study information website; 506 participants have completed the T0 assessment, 336 participants have completed the T1 assessment, and 308 participants have completed the T2 assessment as of May 2021. The study is still in progress, and results will be reported in 2021 and 2022.ConclusionsSelf-guided mobile interventions based on a lifestyle approach might be an attractive approach for young adults due to their preference on self-reliance, healthy living, and increased perceived anonymity. Such interventions are yet understudied, and it is known that interventions addressing solely problem drinking are less appealing to young adults. We hypothesize that the Boozebuster mobile app will effectively reduce drinking levels compared to an alcohol educational website (control condition). If effective, our intervention could be an inexpensive and scalable public health intervention to improve drinking habits in young adults.Trial registrationNetherlands Trial Register NL8828; https://www.trialregister.nl/trial/8828.International registered report identifier (irrid)DERR1-10.2196/29750.

Project description:BackgroundHeavy episodic (binge) drinking is common among young adults and can lead to injury and illness. Young adults who seek care in the Emergency Department (ED) may be disproportionately affected with binge drinking behavior, therefore provide an opportunity to reduce future risk through screening, brief intervention and referral to treatment (SBIRT). Mobile phone text messaging (SMS) is a common form of communication among young adults and has been shown to be effective at providing behavioral support to young adult drinkers after ED discharge. Efficacy of SMS programs to reduce binge drinking remains unknown.Methods/designWe will conduct a three parallel arm, randomized trial. A convenience sample of adults aged 18 to 25 years attending three EDs in Pittsburgh, PA and willing to participate in the study will be screened for hazardous alcohol consumption. Participants identified as hazardous drinkers will then be allocated to either 12 weeks of weekly SMS drinking assessments with feedback (SA+F), SMS drinking assessments without feedback (SA), or a control group. Randomization will be via an independent and remote computerized randomization and will be stratified by study site. The SA+F group will be asked to provide pre-weekend drinking intention as well as post-weekend consumption via SMS and will receive feedback messages focused on health consequences of alcohol consumption, personalized normative feedback, protective drinking strategies and goal setting. Follow-up data on alcohol use and injury related to alcohol will be collected through a password-protected website three, six and nine months later. The primary outcome for the study is binge drinking days (≥4 drinks for women; ≥5 drinks for men) during the previous month, and the main secondary outcome is the proportion of participants who report any injury related to alcohol in the prior three months.DiscussionThis study will test the hypothesis that a mobile phone text-messaging program will result in immediate and durable reductions in binge drinking among at-risk young adults. By testing an intervention group to an assessment-only and control group, we will be able to separate the effect of assessment reactivity. By collecting pre-weekend drinking intentions and post-weekend consumption data in the SA+F group, we will be able to better understand mechanism of change.Trial registrationClinicaltrials.gov NCT01688245.

Project description:Risky driving and hazardous drinking are associated with significant human and economic costs. Brief interventions for more than one risky behavior have the potential to reduce health-compromising behaviors in populations with multiple risk-taking behaviors such as young adults. Emergency department (ED) visits provide a window of opportunity for interventions meant to reduce both risky driving and hazardous drinking.We determined the efficacy of a Screening, Brief Intervention, and Referral to Treatment (SBIRT) protocol addressing risky driving and hazardous drinking. We used a randomized controlled trial design with follow-ups through 12 months. ED patients aged 18 to 44 who screened positive for both behaviors (n = 476) were randomized to brief intervention (BIG), contact control (CCG), or no-contact control (NCG) groups. The BIG (n = 150) received a 20-minute assessment and two 20-minute interventions. The CCG (n = 162) received a 20-minute assessment at baseline and no intervention. The NCG (n = 164) were asked for contact information at baseline and had no assessment or intervention. Outcomes at 3, 6, 9, and 12 months were self-reported driving behaviors and alcohol consumption.Outcomes were significantly lower in BIG compared with CCG through 6 or 9 months, but not at 12 months: Safety belt use at 3 months (adjusted odds ratio [AOR], 0.22; 95% confidence interval [CI], 0.08 to 0.65); 6 months (AOR, 0.13; 95% CI, 0.04 to 0.42); and 9 months (AOR, 0.18; 95% CI, 0.06 to 0.56); binge drinking at 3 months (adjusted rate ratio [ARR] 0.84; 95% CI, 0.74 to 0.97) and 6 months (ARR, 0.81; 95% CI, 0.67 to 0.97); and ?5 standard drinks/d at 3 months (AOR, 0.43; 95% CI, 0.20 to 0.91) and 6 months (AOR, 0.41; 95% CI, 0.17 to 0.98). No substantial differences were observed between BIG and NCG at 12 months.Our findings indicate that SBIRT reduced risky driving and hazardous drinking in young adults, but its effects did not persist after 9 months. Future research should explore methods for extending the intervention effect.

Project description:BACKGROUND:Novel alcohol prevention strategies are needed for heavy-drinking young adults. Sleep problems are common among young adults who drink heavily and are a risk factor for developing an alcohol use disorder (AUD). Young adults, interested in the connection between sleep and alcohol, are open to getting help with their sleep. Therefore, sleep interventions may offer an innovative solution. This study evaluates social media advertising for reaching young adults and recruiting them for a new alcohol prevention program focused on sleep. OBJECTIVE:This study aims to evaluate the effectiveness and cost of using Facebook, Instagram, and Snapchat advertising to reach young adults who drink heavily for a sleep intervention; characterize responders' sleep, alcohol use, and related concerns and interests; and identify the most appealing advertising content. METHODS:In study 1, advertisements targeting young adults with sleep concerns, heavy alcohol use, or interest in participating in a sleep program ran over 3 months. Advertisements directed volunteers to a brief web-based survey to determine initial sleep program eligibility and characterize the concerns or interests that attracted them to click the advertisement. In study 2, three advertisements ran simultaneously for 2 days to enable us to compare the effectiveness of specific advertising themes. RESULTS:In study 1, advertisements generated 13,638 clicks, 909 surveys, and 27 enrolled volunteers in 3 months across the social media platforms. Fees averaged US $0.27 per click, US $3.99 per completed survey, US $11.43 per volunteer meeting initial screening eligibility, and US $106.59 per study enrollee. On average, those who completed the web-based survey were 21.1 (SD 2.3) years of age, and 69.4% (631/909) were female. Most reported sleep concerns (725/909, 79.8%) and an interest in the connection between sleep and alcohol use (547/909, 60.2%), but few had drinking concerns (49/909, 5.4%). About one-third (317/909, 34.9%) were identified as being at risk for developing an AUD based on a validated alcohol screener. Among this subsample, 8.5% (27/317) met the final criteria and were enrolled in the trial. Some volunteers also referred additional volunteers by word of mouth. In study 2, advertisements targeting sleep yielded a higher response rate than advertisements targeting alcohol use (0.91% vs 0.56% click rate, respectively; P<.001). CONCLUSIONS:Social media advertisements designed to target young adults with sleep concerns reached those who also drank alcohol heavily, despite few being concerned about their drinking. Moreover, advertisements focused on sleep were more effective than those focused on drinking. Compared with previous studies, cost-effectiveness was moderate for engagement (impressions to clicks), excellent for conversion (clicks to survey completion), and reasonable for enrollment. These data demonstrate the utility of social media advertising focused on sleep to reach young adults who drink heavily and recruit them for intervention.

Project description:BackgroundRisky drinking in pregnancy by UK women is likely to result in many alcohol-exposed pregnancies. Studies from the USA suggest that brief intervention has promise for alcohol risk reduction in antenatal care. However, further research is needed to establish whether this evidence from the USA is applicable to the UK. This pilot study aims to investigate whether pregnant women can be recruited and retained in a randomized controlled trial of brief intervention aimed at reducing risky drinking in women receiving antenatal care.MethodsThe trial will rehearse the parallel-group, non-blinded design and procedures of a subsequent definitive trial. Over 8 months, women aged 18 years and over (target number 2,742) attending their booking appointment with a community midwife (n = 31) in north-east England will be screened for alcohol consumption using the consumption questions of the Alcohol Use Disorders Identification Test (AUDIT-C). Those screening positive, without a history of substance use or alcohol dependence, with no pregnancy complication, and able to give informed consent, will be invited to participate in the trial (target number 120). Midwives will be randomized in a 1:1 ratio to deliver either treatment as usual (control) or structured brief advice and referral for a 20-minute motivational interviewing session with an alcohol health worker (intervention). As well as demographic and health information, baseline measures will include two 7-day time line follow-back questionnaires and the EuroQoL EQ-5D-3 L questionnaire. Measures will be repeated in telephone follow-ups in the third trimester and at 6 months post-partum, when a questionnaire on use of National Health Service and social care resources will also be completed. Information on pregnancy outcomes and stillbirths will be accessed from central health service records before the follow-ups. Primary outcomes will be rates of eligibility, recruitment, intervention delivery, and retention in the study population, to inform power calculations for a definitive trial. The health-economics component will establish how cost-effectiveness will be assessed, and examine which data on health service resource use should be collected in a main trial. Participants' views on instruments and procedures will be sought to confirm their acceptability.DiscussionThe study will produce a full trial protocol with robust sample-size calculations to extend evidence on effectiveness of screening and brief intervention.Trial registrationCurrent Controlled Trials ISRCTN43218782.

Project description:BackgroundRecent 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).ObjectiveThis 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.MethodsWe 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.ResultsThe 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.ConclusionsThis 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.Trial registrationAustralian New Zealand Clinical Trials Registration (ANZCTR): ACTRN12617001509358p; http://www.anzctr.org.au/ACTRN12617001509358p.aspx.International registered report identifier (irrid)DERR1-10.2196/14190.

Project description:BACKGROUND:Despite intervention efforts to date, the prevalence of risky drinking among adolescents and emerging adults remains high, increasing the risk for health consequences and the development of alcohol use disorders. Peer influences are particularly salient among this age group, including via social media. Thus, the development of efficacious early interventions for youth, delivered with a broad reach via trained peers on social media, could have an important role in addressing risky drinking and concomitant drug use. OBJECTIVE:This paper describes the protocol of a randomized controlled trial (RCT) testing the efficacy of a social media intervention among adolescents and emerging adults who meet the criteria for risky drinking (using the Alcohol Use Disorders Identification Test-Consumption [AUDIT-C]), delivered with and without financial incentives for participation, compared with an attention placebo control condition (ie, entertaining social media content), on alcohol consumption and consequences. METHODS:This RCT involved recruiting 955 youths (aged 16-24 years) via advertisements on Facebook and Instagram to self-administer a brief web-based screening survey. Those screening positive for past 3-month risky drinking (AUDIT-C positive: ages 16-17 years: ?3 females and ?4 males; and ages 18-24 years: ?4 females and ?5 males) were eligible for the RCT. After providing consent (a waiver of parental consent was obtained for minors), participants completed a web-based baseline survey and several verification procedures, including a selfie photo matched to Facebook profile photos. Participants were then randomized to join invitation-only secret Facebook groups, which were not searchable or viewable by parents, friends, or anyone not recruited by the study. The 3 conditions were social media intervention with incentives, social media intervention without incentives (SMI), and attention placebo control. Each condition lasted 8 weeks and consisted of bachelor's-level and master's-level therapist electronic coaches posting relevant content and responding to participants' posts in a manner consistent with Motivational Interviewing. Participants in the control condition and SMI condition did not receive payments but were blind to condition assignment between these 2 conditions. Follow-ups are ongoing and occur at 3, 6, and 12 months poststart of the groups. RESULTS:We enrolled 955 participants over 10 waves of recruitment who screened positive for risky drinking into the RCT. CONCLUSIONS:The findings of this study will provide the critical next step in delivering early alcohol interventions to the youth, capitalizing on social media platforms, which could have significant public health impact by altering alcohol use trajectories of adolescents and emerging adults engaged in risky drinking. TRIAL REGISTRATION:ClinicalTrials.gov NCT02809586; https://clinicaltrials.gov/ct2/show/NCT02809586. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/16688.

Dataset Information

A Multimodal Mobile Sleep Intervention for Young Adults Engaged in Risky Drinking: Protocol for a Randomized Controlled Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

A Multimodal Mobile Sleep Intervention for Young Adults Engaged in Risky Drinking: Protocol for a Randomized Controlled Trial.

Similar Datasets

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