Dataset Information

Randomized controlled trial of a mobile phone intervention for improving adherence to naltrexone for alcohol use disorders.

ABSTRACT:

Background

Naltrexone 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.

Methods

Treatment-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.

Results

The 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.

Conclusions

These 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 registration

ClinicalTrials.gov: NCT01349985.

SUBMITTER: Stoner SA

PROVIDER: S-EPMC4409303 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Randomized controlled trial of a mobile phone intervention for improving adherence to naltrexone for alcohol use disorders.

Stoner Susan A SA Arenella Pamela B PB Hendershot Christian S CS

PloS one 20150424 4

<h4>Background</h4>Naltrexone 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.<h4>Methods</h4>Treatment-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 ...[more]

PMID: 25909320

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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.

Project description:BackgroundCue 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.ObjectiveThe 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.MethodsA 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).ResultsIn 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.ConclusionsCET 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 registrationClinicalTrials.gov NCT02298751; https://clinicaltrials.gov/ct2/show/NCT02298751.

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Project description:BACKGROUND:Interventions to reduce alcohol use typically include several elements, such as information on the risks of alcohol consumption, planning for sensible drinking, and training of protective behavioral strategies. However, the effectiveness of these individual intervention elements within comprehensive programs has not been addressed so far, but it could provide valuable insights for the development of future interventions. Just-in-time interventions provided via mobile devices are intended to help people make healthy decisions in the moment and thus could influence health behavior. OBJECTIVE:The aim of this study was to test the proximal effects of a mobile phone-delivered, just-in-time planning intervention to reduce alcohol use in adolescents who reported recent binge drinking. The efficacy of this individual intervention element was tested within a comprehensive intervention program to reduce problem drinking in adolescents. METHODS:The study had an AB/BA crossover design, in which participants were randomly allocated to (1) a group receiving the planning intervention (A) in period 1 and assessment only (B) in period 2 or (2) a group receiving assessment only (B) in period 1 and the planning intervention (A) in period 2. The planning intervention included a text message to choose one of two predetermined if-then plans to practice sensible drinking with friends or when going out and a prompt to visualize the chosen plan. There was a washout period of at least 1 week between period 1 and period 2. RESULTS:Out of 633 program participants who recently binge drank, 136 (21.5%) were receptive in both periods of time and provided data on the proximal outcome, which was the number of alcoholic drinks consumed with friends or when going out. After the planning intervention, the number of alcoholic drinks consumed was approximately one standard drink lower compared with the finding without the intervention (P=.01). CONCLUSIONS:A mobile phone-delivered, just-in-time, if-then planning intervention to practice sensible drinking with friends or when going out is effective in reducing alcohol consumption among adolescents who report recent binge drinking. Based on the relatively low percentage of participants with self-reported receptivity for the planning intervention, measures to increase the population impact of similar planning interventions should be implemented and tested in future trials. TRIAL REGISTRATION:ISRCTN Registry ISRCTN52150713; http://www.isrctn.com/ISRCTN52150713.

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Dataset Information

Randomized controlled trial of a mobile phone intervention for improving adherence to naltrexone for alcohol use disorders.

Background

Methods

Results

Conclusions

Trial registration

Publications

Randomized controlled trial of a mobile phone intervention for improving adherence to naltrexone for alcohol use disorders.

Similar Datasets

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