Brief motivational therapy versus enhanced usual care for alcohol use disorders in primary care in Chile: study protocol for an exploratory randomized trial

Abstract Background Harmful alcohol use is a leading cause of global disability and death. However, increased detection and brief intervention capacity of more severe alcohol use disorders has not been accompanied by increased availability of treatment services. Incorporating treatment for such disorders into primary care is of paramount importance for improving access and health outcomes. This study aims to estimate the effectiveness of a Brief Motivational Treatment (BMT) applied in primary care for treatment of these disorders. Methods A parallel-group, single-blinded, severity-stratified, randomized clinical trial will test the superiority of BMT over enhanced usual care. Eligible participants will be those seeking treatment and who fulfill DSM-V criteria for alcohol use disorder and criteria for harmful alcohol use. With an estimated a loss to follow-up of 20%, a total of 182 participants will be recruited and equally randomized to each treatment group. The intervention group will receive an adaptation of the motivational enhancement therapy, as manualized in Project MATCH. This treatment consists of four 45-min sessions provided by a general psychologist with at least 3 years of primary care experience. The primary outcome is the change from baseline in the drinks per drinking day during the last 90 days, which will be captured using the Timeline Follow Back method. Secondary outcomes will describe the changes in alcohol use pattern, motivational status, and severity of the disorder. All participants will be analyzed according to the group they were allocated, regardless of the treatment actually received. Mean differences (MD) will be computed for continuous outcomes and relative risks (RR) and RR reductions (RRR) for dichotomous results. Linear models will deliver the subgroup analyses. Missingness is assumed to be associated with the baseline alcohol use pattern and severity, so a multiple imputation method will be used to handle missing data. Discussion This trial aims to test the superiority of BMT over enhanced usual care with a reasonable superiority margin, over which the BMT could be further considered for incorporation into PC in Chile. Its pragmatic approach ultimately aims to inform policymakers about the benefit of including a brief psychosocial treatment into PC. Trial registration ClinicalTrials.gov NCT04345302 . Registered on 28 April 2020Abstract Background Harmful alcohol use is a leading cause of global disability and death. However, increased detection and brief intervention capacity of more severe alcohol use disorders has not been accompanied by increased availability of treatment services. Incorporating treatment for such disorders into primary care is of paramount importance for improving access and health outcomes. This study aims to estimate the effectiveness of a Brief Motivational Treatment (BMT) applied in primary care for treatment of these disorders. Methods A parallel-group, single-blinded, severity-stratified, randomized clinical trial will test the superiority of BMT over enhanced usual care. Eligible participants will be those seeking treatment and who fulfill DSM-V criteria for alcohol use disorder and criteria for harmful alcohol use. With an estimated a loss to follow-up of 20%, a total of 182 participants will be recruited and equally randomized to each treatment group. The intervention group will receive an adaptation of the motivational enhancement therapy, as manualized in Project MATCH. This treatment consists of four 45-min sessions provided by a general psychologist with at least 3 years of primary care experience. The primary outcome is the change from baseline in the drinks per drinking day during the last 90 days, which will be captured using the Timeline Follow Back method. Secondary outcomes will describe the changes in alcohol use pattern, motivational status, and severity of the disorder. All participants will be analyzed according to the group they were allocated, regardless of the treatment actually received. Mean differences (MD) will be computed for continuous outcomes and relative risks (RR) and RR reductions (RRR) for dichotomous results. Linear models will deliver the subgroup analyses. Missingness is assumed to be associated with the baseline alcohol use pattern and severity, so a multiple imputation method will be used to handle missing data. Discussion This trial aims to test the superiority of BMT over enhanced usual care with a reasonable superiority margin, over which the BMT could be further considered for incorporation into PC in Chile. Its pragmatic approach ultimately aims to inform policymakers about the benefit of including a brief psychosocial treatment into PC. Trial registration ClinicalTrials.gov NCT04345302 . Registered on 28 April 2020