Using mobile phone technology to treat alcohol use disorder: study protocol for a randomized controlled trial.
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ABSTRACT: Background
A primary concern within the healthcare system is to make treatment more accessible as well as attractive for the great majority of alcohol-dependent people who feel reluctant to participate in the treatment programs available. This paper presents the protocol for a randomized controlled trial (RCT) to test the efficacy of two different technical devices (mobile phone application and breathalyzer) on alcohol consumption.Methods
The study is a three-armed RCT with follow-ups 3 and 6 months after randomization. In total, 375 adults (age 18+ years) diagnosed with alcohol use disorder (AUD) will be invited to participate in a 3-month intervention. The primary outcome is the number of days with heavy drinking, defined as four or more standard drinks (12 g alcohol/drink) and measured by the timeline follow back (TLFB) and Alcohol Use Disorder Identification Test (AUDIT) instruments at 3-month and 6-month follow-up. Secondary outcome measures include weekly alcohol consumption, measured by the TLFB, AUDIT, and phosphatidylethanol in blood values at 3-month and 6-month follow-up (number of days with blood alcohol concentration levels exceeding 60 mg/100 ml).Discussion
Improving ways of collecting data on alcohol consumption, as well as the treatment system with regards to AUD, is of vital importance. Mobile phone technology, with associated applications, is widely recognized as a potentially powerful tool in the prevention and management of disease. This study will provide unique knowledge regarding the use of new technology as instruments for measuring alcohol consumption and, also, as a possible way to decrease it.Trial registration
ISRCTN, ISRCTN14515753 . Registered on 31 May 2018.
SUBMITTER: Danielsson AK
PROVIDER: S-EPMC6311064 | biostudies-literature | 2018 Dec
REPOSITORIES: biostudies-literature
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Using mobile phone technology to treat alcohol use disorder: study protocol for a randomized controlled trial.
Danielsson Anna-Karin AK Lundin Andreas A Andréasson Sven S
Trials 20181229 1
<h4>Background</h4>A primary concern within the healthcare system is to make treatment more accessible as well as attractive for the great majority of alcohol-dependent people who feel reluctant to participate in the treatment programs available. This paper presents the protocol for a randomized controlled trial (RCT) to test the efficacy of two different technical devices (mobile phone application and breathalyzer) on alcohol consumption.<h4>Methods</h4>The study is a three-armed RCT with follo ...[more]
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Project description:BACKGROUND:About 50% of university students overconsume alcohol, and drinking habits in later adulthood are to some extent established during higher educational studies. Several studies have demonstrated that Internet-based interventions have positive effects on drinking habits among university students. Our recent study evaluated two mobile phone apps targeting drinking choices at party occasions via personalized feedback on estimated blood alcohol concentration (eBAC) for students with hazardous drinking. No changes in drinking parameters were found over a seven-week period apart from an increase in number of drinking occasions among men for one of the apps tested. Up to 30% of the study participants drank at potentially harmful levels: higher than the national recommended number of standard drinks per week (a maximum of 9 for women and 14 for men) in Sweden. OBJECTIVE:(1) To evaluate improved versions of the two mobile phone apps tested in our prior trial, in a new, 3-armed randomized controlled trial among university students with at least hazardous drinking habits according to the Alcohol Use Disorders Identifications Test (AUDIT; Study 1). (2) After 6 weeks, to target study participants showing alcohol consumption higher than the national recommended levels for standard drinks per week by offering them participation in a second, 2-armed randomized trial evaluating an additional mobile phone app with skill enhancement tasks (Study 2). (3) To follow participants at 6, 12 and 18 weeks after recruitment to Study 1 and at 6 and 12 weeks after recruitment to Study 2. METHODS:Two randomized controlled trials are conducted. Study 1: Students are recruited at four Swedish universities, via direct e-mail and advertisements on Facebook and student union web sites. Those who provide informed consent, have a mobile phone, and show at least hazardous alcohol consumption according to the AUDIT (?6 for women; ?8 points for men) are randomized into three groups. Group 1 has access to the Swedish government alcohol monopoly's app, Promillekoll, offering real-time estimated eBAC calculation; Group 2 has access to a Web-based app, PartyPlanner, developed by the research group, offering real-time eBAC calculation with planning and follow-up functions; and Group 3 participants are controls. Follow-up is conducted at 6, 12 and 18 weeks. Study 2. Participants who at the first 6-week follow-up show drinking levels higher than 9 (W) or 14 (M) standard drinks (12 g alcohol) per week, are offered participation in Study 2. Those who consent are randomized to either access to a skills training app, TeleCoach or to a wait-list control group. RESULTS:Latent Markov models for Study 1 and mixed models analyses for Study 2 will be performed. Study 2 data will be analyzed for publication during the spring of 2016; Study 1 data will be analyzed for publication during the fall of 2016. CONCLUSIONS:If mobile phone interventions for reducing hazardous alcohol use are found to be effective, the prospects for positively influencing substance use-related health among university students can considerably improve. TRIAL REGISTRATION:ClinicalTrials.gov http://clinicaltrials.gov/ct2/show/NCT02064998 (Archived by WebCite at http://www.webcitation.org/6dy0AlVRP).
| S-EPMC4704963 | biostudies-literature
Project description:Brief interventions via the internet have been shown to reduce university students' alcohol intake. This study tested two smartphone applications (apps) targeting drinking choices on party occasions, with the goal of reducing problematic alcohol intake among Swedish university students.Students were recruited via e-mails sent to student union members at two universities. Those who gave informed consent, had a smartphone, and showed risky alcohol consumption according to the Alcohol Use Disorders Identification Test (AUDIT) were randomized into three groups. Group 1 had access to the Swedish government alcohol monopoly's app, Promillekoll, offering real-time estimated blood alcohol concentration (eBAC) calculation; Group 2 had access to a web-based app, PartyPlanner, developed by the research group, offering real-time eBAC calculation with planning and follow-up functions; and Group 3 participants were controls. Follow-up was conducted at 7 weeks.Among 28574 students offered participation, 4823 agreed to join; 415 were excluded due to incomplete data, and 1932 fulfilled eligibility criteria for randomization. Attrition was 22.7-39.3 percent, higher among heavier drinkers and highest in Group 2. Self-reported app use was higher in Group 1 (74%) compared to Group 2 (41%). Per-protocol analyses revealed only one significant time-by-group interaction, where Group 1 participants increased the frequency of their drinking occasions compared to controls (p?=?0.001). Secondary analyses by gender showed a significant difference among men in Group 1 for frequency of drinking occasions per week (p?=?0.001), but not among women. Among all participants, 29 percent showed high-risk drinking, over the recommended weekly drinking levels of 9 (women) and 14 (men) standard glasses.Smartphone apps can make brief interventions available to large numbers of university students. The apps studied using eBAC calculation did not, however, seem to affect alcohol consumption among university students and one app may have led to a negative effect among men. Future research should: 1) explore ways to increase user retention, 2) include apps facilitating technical manipulation for evaluation of added components, 3) explore the effects of adapting app content to possible gender differences, and 4) offer additional interventions to high-risk users.clinicaltrials.gov: NCT01958398.
| S-EPMC4091647 | biostudies-literature
Project description:BackgroundNaltrexone is a front-line treatment for alcohol use disorders, but its efficacy is limited by poor medication adherence. This randomized controlled trial evaluated whether a mobile health intervention could improve naltrexone adherence.MethodsTreatment-seeking participants with an alcohol use disorder (N = 76) were randomized to intervention and control conditions. All participants received naltrexone (50 mg/day) with a medication event monitoring system (MEMS) and a prepaid smartphone, and received a daily text message querying medication side effects, alcohol use, and craving. Those in the intervention arm received additional medication reminders and adherence assessment via text message.ResultsThe primary outcome, proportion of participants with adequate adherence (defined as ?80% of prescribed doses taken through Week 8), did not differ between groups in intent-to-treat analyses (p = .34). Mean adherence at study midpoint (Week 4) was 83% in the intervention condition and 77% in the control condition (p = .35). Survival analysis found that the intervention group sustained adequate adherence significantly longer (M = 19 days [95% CI = 0.0-44.0]) than those in the control group (M = 3 days [95% CI = 0.0-8.1]) during the first month of treatment (p = .04). Medication adherence did not predict drinking outcomes.ConclusionsThese results suggest that in the context of daily monitoring and assessment via cell phone, additional text message reminders do not further improve medication adherence. Although this initial trial does not provide support for the efficacy of text messaging to improve adherence to pharmacotherapy for alcohol use disorders, additional trials with larger samples and alternate designs are warranted.Trial registrationClinicalTrials.gov: NCT01349985.
| S-EPMC4409303 | biostudies-literature
Project description:BACKGROUND:Cue exposure therapy (CET) is a psychological approach developed to prepare individuals with alcohol use disorder (AUD) for confronting alcohol and associated stimuli in real life. CET has shown promise when treating AUD in group sessions, but it is unknown whether progressing from group sessions to using a mobile phone app is an effective delivery pathway. OBJECTIVE:The objectives of this study were to investigate (1) whether CET as aftercare would increase the effectiveness of primary treatment with cognitive behavior therapy, and (2) whether CET delivered through a mobile phone app would be similarly effective to CET via group sessions. METHODS:A total of 164 individuals with AUD were randomized to one of three groups: CET as group aftercare (CET group), CET as fully automated mobile phone app aftercare (CET app), or aftercare as usual. Study outcomes were assessed face-to-face at preaftercare, postaftercare, and again at 6 months after aftercare treatment. Generalized mixed models were used to compare the trajectories of the groups over time on drinking, cravings, and use of urge-specific coping skills (USCS). RESULTS:In all, 153 of 164 individuals (93%) completed assessments both at posttreatment and 6-month follow-up assessments. No differences in the trajectories of predicted means were found between the experimental groups (CET group and app) compared with aftercare as usual on drinking and craving outcomes over time. Both CET group (predicted mean difference 5.99, SE 2.59, z=2.31, P=.02) and the CET app (predicted mean difference 4.90, SE 2.26, z=2.31, P=.02) showed increased use of USCS compared to aftercare as usual at posttreatment, but this effect was reduced at the 6-month follow-up. No differences were detected between the two experimental CET groups on any outcomes. CONCLUSIONS:CET with USCS delivered as aftercare either via group sessions or a mobile phone app did not increase the effectiveness of primary treatment. This suggests that CET with USCS may not be an effective psychological approach for the aftercare of individuals treated for AUD. TRIAL REGISTRATION:ClinicalTrials.gov NCT02298751; https://clinicaltrials.gov/ct2/show/NCT02298751.
| S-EPMC6716334 | biostudies-literature
Project description:AimTo test the effectiveness of a motivational interviewing (MI) intervention using the mobile phone among adults with alcohol use problems.DesignA randomized clinical trial of mobile MI and standard in-person MI with 1- and 6-month follow-up, including a 1-month waitlist control followed by mobile MI.SettingA primary health center in rural Kenya.ParticipantsThree hundred adults screening positive for alcohol use problems were randomized and received immediate mobile MI (n = 89), in-person MI (n = 65) or delayed mobile MI (n = 76) for waiting-list controls 1 month after no treatment, with 70 unable to be reached for intervention.Intervention and comparatorOne MI session was provided either immediately by mobile phone, in-person at the health center or delayed by 1 month and then provided by mobile phone.MeasurementsAlcohol use problems were repeatedly assessed using the Alcohol Use Disorder Identification Test (AUDIT) and the shorter AUDIT-C. The primary outcome was difference in alcohol score 1 month after no intervention for waiting-list control versus 1 month after MI for mobile MI. The secondary outcomes were difference in alcohol score for in-person MI versus mobile MI one and 6 months after MI.FindingsFor our primary outcome, average AUDIT-C scores were nearly three points higher (difference = 2.88, 95% confidence interval = 2.11, 3.66) for waiting-list controls after 1 month of no intervention versus mobile MI 1 month after intervention. Results for secondary outcomes supported the null hypothesis of no difference between in-person and mobile MI at 1 month (Bayes factor = 0.22), but were inconclusive at 6 months (Bayes factor = 0.41).ConclusionMobile phone-based motivational interviewing may be an effective treatment for alcohol use problems among adults visiting primary care in Kenya. Providing mobile motivational interviewing may help clinicians in rural areas to reach patients needing treatment for alcohol use problems.
| S-EPMC8353663 | biostudies-literature
Project description:BackgroundReal-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.ObjectiveWe 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.MethodsWe 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.ResultsA 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 ?22 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.ConclusionsWith 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.Trial registrationAustralian 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).
| S-EPMC6076370 | biostudies-literature
Project description:It is well documented that individuals with Alcohol Use Disorder (AUD) respond well during evidence-based psychological treatment, but also that a large proportion relapses when discharged from treatment and confronted with alcohol in real life. Cue Exposure Treatment (CET) focuses on exposing individuals to alcohol cues in order to reduce cravings as well as the likelihood of relapse. The aims of the study are: 1) to investigate whether CET aftercare delivered via a smartphone or in group sessions increases the effect of Cognitive Behavioural Treatment in groups of alcohol dependent individuals; 2) to investigate whether CET as a smartphone application is as or more effective than CET group therapy, and 3) to investigate whether CET as a smartphone application is more cost-effective than CET group aftercare and Aftercare as Usual.The study will be implemented as an investigator-blinded randomized controlled trial. A total of 300 consecutively enrolled alcohol use disorder individuals recruited from an alcohol outpatient clinic will be randomized into one of the three following aftercare groups after concluding primary treatment: (1) CET as a smartphone application; (2) CET as group therapy, and (3) Aftercare as Usual. It is hypothesized that the two experimental groups will achieve better treatment outcomes compared to the control group (3).Individuals in the CET groups are given the opportunity to practise coping strategies during exposure to alcohol stimuli before being unavoidably confronted with alcohol and associated stimuli in real life. Thus, CET may help prevent patients from relapsing after concluding treatment, and in the long term. Moreover, the CET application has the potential to improve AUD treatment and continuing care by offering psychological treatment whenever and wherever the patient finds it convenient.ClinicalTrials.gov ID: NCT02298751 Registration date: 6 November 2014.
| S-EPMC4839102 | biostudies-literature
Project description:BACKGROUND:New smartphone communication technology provides a novel way to provide personalized continuing care support following alcohol treatment. One such system is the Addiction version of the Comprehensive Health Enhancement Support System (A-CHESS), which provides a range of automated functions that support patients. A-CHESS improved drinking outcomes over standard continuing care when provided to patients leaving inpatient treatment. Effective continuing care can also be delivered via telephone calls with a counselor. Telephone Monitoring and Counseling (TMC) has demonstrated efficacy in two randomized trials with alcohol-dependent patients. A-CHESS and TMC have complementary strengths. A-CHESS provides automated 24/7 recovery support services and frequent assessment of symptoms and status, but does not involve regular contact with a counselor. TMC provides regular and sustained contact with the same counselor, but no ongoing support between calls. The future of continuing care for alcohol use disorders is likely to involve automated mobile technology and counselor contact, but little is known about how best to integrate these services. METHODS/DESIGN:To address this question, the study will feature a 2?×?2 design (A-CHESS for 12 months [yes/no]?×?TMC for 12 months [yes/no]), in which 280 alcohol-dependent patients in intensive outpatient programs (IOPs) will be randomized to one of the four conditions and followed for 18 months. We will determine whether adding TMC to A-CHESS produces fewer heavy drinking days than TMC or A-CHESS alone and test for TMC and A-CHESS main effects. We will determine the costs of each of the four conditions and the incremental cost-effectiveness of the three active conditions. Analyses will also examine secondary outcomes, including a biological measure of alcohol use, and hypothesized moderation and mediation effects. DISCUSSION:The results of the study will yield important information on improving patient alcohol use outcomes by integrating mobile automated recovery support and counselor contact. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02681406 . Registered on 2 September 2016.
| S-EPMC5791199 | biostudies-literature
Project description:BACKGROUND:Monitoring signs and symptoms in bipolar disorder (BP) is typically based on regular assessments from patient-clinician interactions. Mobile and wearable technology promises to make monitoring symptoms in BP easier, but little is known about how best to engage individuals with BP in monitoring symptoms. OBJECTIVE:The objective of this study was to provide the rationale and protocol for a randomized controlled trial that investigates engagement strategies for monitoring symptoms of BP, including the strategies of using activity trackers compared with self-reports and reviewing recorded symptoms weekly with an interviewer. METHODS:A total of 50 individuals with BP will be recruited from the Prechter Longitudinal Study of Bipolar Disorder at the University of Michigan to participate in a 6-week study. Participants will monitor their symptoms through an activity tracker (Fitbit Alta HR) and a mobile phone app designed for this study. In addition to monitoring symptoms, participants have a 50-50 chance of being assigned to an arm that reviews self-reports and activity information weekly. Statistical tests will be performed to test hypotheses that participants adhere to activity tracking significantly more than self-reporting, prefer activity tracking significantly more than self-reporting, and better adhere to both activity tracking and self-reporting when reviewing collected information weekly. RESULTS:Recruitment commenced in November 2017. The first group of participants began the study in January 2018. CONCLUSIONS:This study aims to establish strategies to engage individuals with BP in monitoring their symptoms with mobile and wearable technology. Better engagement strategies are expected to aid current efforts in bipolar research and clinical care, from the development of new mobile phone apps to providing the right intervention to the right individual at the right moment. TRIAL REGISTRATION:ClinicalTrials.gov NCT03358238; https://clinicaltrials.gov/ct2/show/NCT03358238 (Archived by WebCite at http://www.webcitation.org/6yebuNfz5). REGISTERED REPORT IDENTIFIER:RR1-10.2196/9899.
| S-EPMC5968216 | biostudies-literature
Project description:BACKGROUND:At-risk patterns of alcohol use are prevalent in many countries with significant costs to individuals, families, and society. Screening and brief interventions, including with Web delivery, are effective but with limited translation into practice to date. Previous observational studies of the Hello Sunday Morning approach have found that their unique Web-based participatory health communication method has resulted in a reduction of at-risk alcohol use between baseline and 3 months. The Hello Sunday Morning blog program asks participants to publicly set a personal goal to stop drinking or reduce their consumption for a set period of time, and to record their reflections and progress on blogs and social networks. Daybreak is Hello Sunday Morning's evidence-based behavior change program, which is designed to support people looking to change their relationship with alcohol. OBJECTIVE:This study aims to systematically evaluate different versions of Hello Sunday Morning's Daybreak program (with and without coaching support) in reducing at-risk alcohol use. METHODS:We will use a between groups randomized control design. New participants enrolling in the Daybreak program will be eligible to be randomized to receive either (1) the Daybreak program, including peer support plus behavioral experiments (these encourage and guide participants in developing new skills in the areas of mindfulness, connectedness, resilience, situational strategies, and health), or (2) the Daybreak program, including the same peer support plus behavioral experiments, but with online coaching support. We will recruit 467 people per group to detect an effect size of f=0.10. To be eligible, participants must be resident in Australia, aged ?18 years, score ?8 on the alcohol use disorders identification test (AUDIT), and not report prior treatment for cardiovascular disease. RESULTS:The primary outcome measure will be reduction in the AUDIT-Consumption (AUDIT-C) scores. Secondary outcomes include mental health (Kessler's K-10), days out of role (Kessler), alcohol consumed (measured with a 7-day drinking diary in standard 10 g drinks), and alcohol-related harms (CORE alcohol and drug survey). We will collect data at baseline and 1, 3, and 6 months and analyze them with random effects models, given the correlated data structure. CONCLUSIONS:A randomized trial is required to provide robust evidence of the impact of the online coaching component of the Daybreak program, including over an extended period. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12618000010291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373110 (Archived by WebCite at http://www.webcitation.org/6zKRmp0aC). REGISTERED REPORT IDENTIFIER:RR1-10.2196/9982.
| S-EPMC6002672 | biostudies-literature