A randomized trial evaluating an mHealth system to monitor and enhance adherence to pharmacotherapy for alcohol use disorders

BACKGROUND: Nonadherence to prescribed medication regimens is a substantial barrier to the pharmacological management of alcohol use disorders. The availability of low-cost, sustainable interventions that maximize medication adherence would likely lead to improved treatment outcomes. Mobile health (mHealth) technologies are increasingly being adopted as a method of delivering behavioral health interventions and represent a promising tool for adherence interventions. We are evaluating a cell-phone–based intervention called AGATE that seeks to enhance adherence with regular text-messaging. METHODS/DESIGN: A randomized controlled effectiveness trial in the context of an eight-week open label naltrexone efficacy trial delivered in a naturalistic clinical setting. Treatment-seeking heavy drinkers (N = 105) are currently being recruited and randomly assigned to the AGATE intervention or a control condition. Daily measures of alcohol use and medication side effects are being recorded via cell phone in both conditions. Additionally, participants randomized to the AGATE condition receive medication reminders via SMS text message according to a schedule that adjusts according to their level of adherence. DISCUSSION: Results from this trial will provide initial information about the feasibility and efficacy of mHealth interventions for improving adherence to alcohol pharmacotherapies. TRIAL REGISTRATION: NCT01349985

Treatment dismantling pilot study to identify the active ingredients in personalized feedback interventions for hazardous alcohol use: randomized controlled trial

BACKGROUND There is a considerable body of evidence supporting the effectiveness of personalized feedback interventions for hazardous alcohol use-whether delivered face-to-face, by postal mail, or over the Internet (probably now the primary mode of delivery). The Check Your Drinking Screener (CYD; see www.CheckYourDrinking.net) is one such intervention. OBJECTIVES The current treatment dismantling study assessed which components of personalized feedback interventions were effective in motivating change in drinking. Specifically, the major objective of this project was to conduct a randomized controlled trial (RCT) comparing the impact of the normative feedback and other personalized feedback components of the CYD intervention in the general population. METHODS Participants were recruited to take part in an RCT and received either the complete CYD final report, just the normative feedback sections of the CYD, just the personalized feedback components of the CYD, or were assigned to a no-intervention control group. Participants were followed-up at 3 months to assess changes in alcohol consumption. RESULTS A total of 741 hazardous drinking participants were recruited for the trial, of which 73 percent provided follow-up data. Analyses using an intent-to-treat approach found some evidence for the impact of the personalized feedback components of the CYD in reducing alcohol consumption on the variables, number of drinks in a week and AUDIT-C (p = .028 and .047 respectively; no impact on highest number of drinks on one occasion; p = .594). However, there was no significant evidence of the impact of the normative feedback components (all p > .3). CONCLUSIONS Personalized feedback elements alone could provide an active intervention for hazardous drinkers, particularly in situations where normative feedback information was not available. TRIALS REGISTRATION ClinicalTrials.gov NCT01608763

Pragmatic randomized controlled trial of providing access to a brief personalized alcohol feedback intervention in university students

BACKGROUND There is a growing body of evidence indicating that web-based personalized feedback interventions can reduce the amount of alcohol consumed in problem drinking college students. This study sought to evaluate whether providing voluntary access to such an intervention would have an impact on drinking. METHODS College students responded to an email inviting them to participate in a short drinking survey. Those meeting criteria for risky drinking (and agreeing to participate in a follow-up) were randomized to an intervention condition where they were offered to participate in a web-based personalized feedback intervention or to a control condition (intervention not offered). Participants were followed-up at six weeks. RESULTS A total of 425 participants were randomized to condition and 68% (n = 290) completed the six-week follow-up. No significant difference in drinking between conditions was observed. CONCLUSIONS Web-based personalized feedback interventions that are offered to students on a voluntary basis may not have a measurable impact on problem drinking. TRIAL REGISTRATION ClinicalTrials.gov: NCT01521078.Support to CAMH for salary of scientists and infrastructure has been provided by the Ontario Ministry of Health and Long Term Care

Use of mobile devices to answer online surveys: implications for research

BACKGROUND There is a growing use of mobile devices to access the Internet. We examined whether participants who used a mobile device to access a brief online survey were quicker to respond to the survey but also, less likely to complete it than participants using a traditional web browser. FINDINGS Using data from a recently completed online intervention trial, we found that participants using mobile devices were quicker to access the survey but less likely to complete it compared to participants using a traditional web browser. More concerning, mobile device users were also less likely to respond to a request to complete a six week follow-up survey compared to those using traditional web browsers. CONCLUSIONS With roughly a third of participants using mobile devices to answer an online survey in this study, the impact of mobile device usage on survey completion rates is a concern. TRIAL REGISTRATION ClinicalTrials.gov: NCT01521078

Online interventions for problem gamblers with and without co-occurring mental health symptoms: protocol for a randomized controlled trial

BACKGROUND Comorbidity between problem gambling and depression or anxiety is common. Further, the treatment needs of people with co-occurring gambling and mental health symptoms may be different from those of problem gamblers who do not have a co-occurring mental health concern. The current randomized controlled trial (RCT) will evaluate whether there is a benefit to providing access to mental health Internet interventions (G + MH intervention) in addition to an Internet intervention for problem gambling (G-only intervention) in participants with gambling problems who do or do not have co-occurring mental health symptoms. METHODS Potential participants will be screened using an online survey to identify participants meeting criteria for problem gambling. As part of the baseline screening process, measures of current depression and anxiety will be assessed. Eligible participants agreeing (N = 280) to take part in the study will be randomized to one of two versions of an online intervention for gamblers – an intervention that just targets gambling issues (G-only) versus a website that contains interventions for depression and anxiety in addition to an intervention for gamblers (G + MH). It is predicted that problem gamblers who do not have co-occurring mental health symptoms will display no significant difference between intervention conditions at a six-month follow-up. However, for those with co-occurring mental health symptoms, it is predicted that participants receiving access to the G + MH website will display significantly reduced gambling outcomes at six-month follow-up as compared to those provided with G-only website. DISCUSSION The trial will produce information on the best means of providing online help to gamblers with and without co-occurring mental health symptoms.This research was funded by the Manitoba Gambling Research Program of Manitoba Liquor and Lotteries

Daily associations between cannabis use and alcohol use among people who use cannabis for both medicinal and nonmedicinal reasons: Substitution or complementarity?

Objective: People who use cannabis for medicinal (versus nonmedicinal) reasons report greater cannabis use and lower alcohol use, which may reflect a cannabis–alcohol substitution effect in this population. However, it is unclear whether cannabis is used as a substitute or complement to alcohol at the day level among people who use cannabis for both medicinal and nonmedicinal reasons. This study used ecological momentary assessment (EMA) to examine this question. Method: Participants (N = 66; 53.1% men; mean age 33 years) completed daily surveys assessing previous-day reasons for cannabis use (medicinal versus nonmedicinal), cannabis consumption (both number of different types of cannabis used and grams of cannabis flower used), and number of standard drinks consumed. Results: Multilevel models revealed that, in general, greater cannabis consumption on a given day was associated with greater same-day alcohol use. Further, days during which cannabis was used for medicinal (versus exclusively nonmedicinal) reasons were associated with reduced consumption of both cannabis and alcohol. Finally, the day-level association between medicinal reasons for cannabis use and lower alcohol consumption was mediated by using fewer grams of cannabis on medicinal cannabis use days. Conclusions: Day-level cannabis-alcohol associations may be complementary rather than substitutive among people who use cannabis for both medicinal and nonmedicinal reasons, and lower (rather than greater) cannabis consumption on medicinal use days may explain the link between medicinal reasons for cannabis use and reduced alcohol use. Still, these individuals may use greater amounts of both cannabis and alcohol when using cannabis for exclusively nonmedicinal reasons.This research was supported by grants from the Canadian Institutes of Health Research Canadian HIV Trials Network (CTN PT037; PIs: Jeffrey D. Wardell and Sergio Rueda) and from the Canadian Institutes of Health Research (159754; PIs: Jeffrey D. Wardell and Christian S. Hendershot). The views expressed herein do not necessarily represent the official policy of the Canadian Institutes of Health Research. Sergio Rueda holds an Innovator Award from the Ontario HIV Treatment Network

Predictors of Daily Adherence to Naltrexone for Alcohol Use Disorder Treatment During a Mobile Health Intervention

Background Adherence to medications for treating alcohol use disorder (AUD) is poor. To identify predictors of daily naltrexone adherence over time, a secondary data analysis was conducted of a trial evaluating a mobile health intervention to improve adherence. Methods Participants seeking treatment for AUD (n = 58; M-age = 38 years; 71% male) were prescribed naltrexone for 8 weeks. Adherence was tracked using the Medication Event Monitoring System (MEMS). In response to daily text messages, participants reported the previous day's alcohol use, craving, and naltrexone side effects. Using multilevel structural equation modeling (MSEM), we examined baseline dispositional factors and within-person, time-varying factors as predictors of daily adherence. Results Naltrexone adherence decreased over time. Adherence was higher on days when individuals completed daily mobile assessments relative to days when they did not (odds ratio [OR] = 2.53, 95% confidence interval [CI] 1.61 to 3.98), irrespective of intervention condition. Days when individuals drank more than their typical amount were related to lower next-day adherence (OR = 0.93, 95% CI 0.88 to 0.99). A similar pattern was supported for craving (OR = 0.88, 95% CI 0.79 to 0.98). Weekend days were associated with lower adherence than weekdays (OR = 0.71, 95% CI 0.58 to 0.86); this effect was partly mediated by heavier daily drinking (indirect effect = -0.02, 95% CI -0.04 to -0.003) and stronger-than-usual craving (indirect effect = -0.01, 95% CI -0.02 to 0.00) on weekend days. Conclusions The results further demonstrate the need to improve adherence to AUD pharmacotherapy. The present findings also support developing interventions that target daily-level risk factors for nonadherence. Mobile health interventions may be one means of developing tailored and adaptive adherence interventions

Randomized Controlled Trial of a Brief Versus Extended Internet Intervention for Problem Drinkers

Purpose Brief Internet interventions have been shown to reduce alcohol consumption. This trial intended to compare the effects of one such brief intervention to an extended Internet intervention for problem drinkers. Method Using online advertising, 490 participants, 18 years or older, were recruited and randomized to receive a brief (CheckYourDrinking.net) versus an extended (AlcoholHelpCentre.net) Internet intervention and were followed up at 6, 12, and 24 months. The per protocol primary analysis assessed difference between condition at the 12-month follow-up. Results The follow-up rate at 12 months was 83.3 %. ANCOVAs of the primary (Alcohol Use Disorder Identification Test (AUDIT)-C) and secondary outcome variables (drinks in a typical week, highest number of drinks on one occasion—baseline drinking as covariate) revealed no significant (p > 0.05) differences between the interventions. Similarly, combined analyses of the 6-, 12-, and 24-month follow-up revealed no significant differences between interventions at all time points. Conclusion The present study does not provide support for the added benefit of an extended Internet intervention for problem drinkers over a brief Internet intervention.The study was funded by the Canadian Institutes of Health Research, grant no. 285651

Does providing a brief internet intervention for hazardous alcohol use to people seeking online help for depression reduce both alcohol use and depression symptoms among participants with these co-occurring disorders? Study protocol for a randomised controlled trial

Introduction Hazardous alcohol consumption is common among people experiencing depression, often acting to exacerbate depressive symptoms. While many people with these co-occurring disorders do not seek face-to-face treatment, they do seek help online. There are effective internet interventions that target hazardous alcohol consumption or depression separately but none that combine these online interventions without the involvement of a therapist. In order to realise the potential of internet interventions, we need to develop an evidence base supporting the efficacy of internet interventions for co-occurring depression and hazardous alcohol use without any therapist involvement. This study aims to evaluate the effects on drinking, and on depressive symptoms, of combining an internet intervention targeting hazardous alcohol consumption with one for depression. Methods and analysis A double blinded, parallel group randomised controlled trial will be used. Participants with current depression who also drink in a hazardous fashion (n=986) will be recruited for a study to ‘help improve an online intervention for depression’. Participants will be randomised either to receive an established online intervention for depression (MoodGYM) or to receive MoodGYM plus a brief internet intervention for hazardous alcohol consumption (Check Your Drinking; CYD). Participants will be contacted 3 and 6 months after receiving the interventions to assess changes in drinking and depression symptoms. It is predicted that participants receiving the CYD intervention in addition to MoodGYM will report greater postintervention reductions in alcohol consumption and depressive symptoms compared with those who received MoodGYM only. Hypothesised mediation and moderation effects will also be investigated. Using an intention-to-treat basis for the analyses, the hypotheses will be tested using a generalised linear hypothesis framework, and longitudinal analyses will use either generalised linear mixed modelling or generalised estimating equation approach where appropriate. Ethics and dissemination This research comprises the crucial first steps in developing lower-cost and efficacious internet interventions for people suffering from depression who also drink in a hazardous fashion—promoting the widespread availability of care for those in need. This study has been approved by the standing ethics review committee of the Centre for Addiction and Mental Health, and findings will be disseminated in the form of at least one peer-reviewed article and presentations at conferences.This research is funded by the Canadian Institutes of Health Research grant no PJT 153 324