Randomized Controlled Trial of a Mobile Phone Intervention for Improving Adherence to Naltrexone for Alcohol Use Disorders

<div><p>Background</p><p>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.</p><p>Methods</p><p>Treatment-seeking participants with an alcohol use disorder (<i>N</i> = 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.</p><p>Results</p><p>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 (<i>p</i> = .34). Mean adherence at study midpoint (Week 4) was 83% in the intervention condition and 77% in the control condition (<i>p</i> = .35). Survival analysis found that the intervention group sustained adequate adherence significantly longer (<i>M</i> = 19 days [95% CI = 0.0–44.0]) than those in the control group (<i>M</i> = 3 days [95% CI = 0.0–8.1]) during the first month of treatment (<i>p</i> = .04). Medication adherence did not predict drinking outcomes.</p><p>Conclusions</p><p>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.</p><p>Trial Registration</p><p>ClinicalTrials.gov: <a href="https://clinicaltrials.gov/ct2/show/NCT01349985" target="_blank">NCT01349985</a></p></div

Coefficients from Intent-to-Treat (ITT) and Per-Protocol (PP) Analysis of Adherence.

<p>Coefficients from Intent-to-Treat (ITT) and Per-Protocol (PP) Analysis of Adherence.</p

Baseline Demographic and Clinical Characteristics of Randomized Participants.

<p>*Drinking variables were computed for preceding 90 days using the Timeline Followback Questionnaire.</p><p>Baseline Demographic and Clinical Characteristics of Randomized Participants.</p

Changes in Self-Reported Drinking and Craving.

<p>95% confidence intervals around the mean numbers of self-reported drinks per drinking day (line graph) and ratings of alcohol craving intensity (column graph), assessed via smartphone, among heavy drinkers randomly assigned to the intervention or control condition. The number of participants making at least one report for each time frame is the number shown in the columns.</p

Study CONSORT diagram.

<p>Study CONSORT diagram.</p

Augmenting Mental Health Support for Patients Accessing Different Degrees of Formal Psychiatric Care through a Supportive Text Messaging Program: Protocol for a Randomized Controlled Trial

Patients feel more vulnerable when accessing community mental health programs for the first time or after being discharged from psychiatric inpatient units. Long wait times for follow-up appointments, shortage of mental health professionals, lack of service integration, and scarcity of tailored support can weaken their connection to the health care system. As a result, patients can present low adherence, dissatisfaction with treatment, and recurrent hospitalizations. Finding solutions to avoid unnecessary high-cost services and providing tailored and cost-effective mental health interventions may reduce the health system burden and augment patient support. We propose implementing an add-on, supportive text messaging service (Text4Support), developed using cognitive–behavioural therapy (CBT) principles to augment mental health support for patients attending to or being discharged from psychiatric care in Nova Scotia, Canada. This randomized controlled trial aims to investigate the effectiveness of Text4Support in improving mental health outcomes and overall mental well-being compared with usual care. We also will examine the intervention’s impact on health services utilization and patient satisfaction. The results from this study will provide evidence on stepped and technology-based mental health care, which will contribute to generating new knowledge about mental health innovations in various clinical contexts, which is not only helpful for the local context but to other jurisdictions in Canada and abroad that are seeking to improve their health care