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 (AUD) has not been accompanied by increased availability of treatment services. Incorporating treatment for such disorders into primary care (PC) 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. This trial aims to test the superiority of BMT over enhanced usual care with a reasonable 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.
This exploratory trial aims to estimate the effectiveness of a BMT for AUD provided in PC. The underlying question is whether Chilean PC should incorporate this treatment among its regular programs based on its effectiveness. To answer this question, a randomised comparison between the manualized BMT and EUC will be undertaken. The main hypothesis is a superiority one: • Participants under BMT will perform better than EUC in the reduction of alcohol consumption. Also, there are ancillary questions that deserve special attention. The following hypotheses will help with the explanation of the results: * Active BMT components (i.e., the working alliance and fidelity to the MI strategies) mediate the effect. * Participant´s AUD severity mediates the effect. * Participants under BMT will receive a higher amount of additional care (physician consultations, social worker consultations, participation in alcoholic anonymous, and others).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
182
The treatment will be delivered by general psychologists with at least three years of experience in primary care. They will receive training and then will demonstrate proficiency in a simulated client session. During recruitment, therapy sessions will be recorded, and ten percent of them will be reviewed using a proficiency scale. Then, a feedback report will be issued and discussed with each therapist.
During the trial, participants will continue to receive regular medical and social care at their health centre. These services may include prescriptions for mental health issues and alcohol (Disulfiram, anti-craving, anti-depressants, and other medications), social assistance, and the full spectrum of primary health care. Nevertheless, they will not receive other psychosocial interventions for alcohol use disorder in the health centre.
CESFAM Juan Pablo II
Santiago, Chile
RECRUITINGCESFAM Madre Teresa de Calcuta
Santiago, Chile
RECRUITINGCESFAM San Alberto Hurtado
Santiago, Chile
RECRUITINGChange in the Drinks per Drinking Day (DDD)
The change from baseline in the DDD during the last 90 days. The DDD will be aggregated using means.
Time frame: Baseline and six-months follow-up
Change in the alcohol use pattern
The number of participants with a low-risk alcohol use pattern estimated by the number of days of consumption, of abstinence, and intoxication during the last 90 days, aggregated using the proportion of participants per group.
Time frame: Baseline and six-months follow-up
Abstinence days
The most extended period of abstinence since enrolment. The number of abstinence days of each participant will be aggregated using means.
Time frame: At six-months follow-up
Change in the negative consequences of alcohol use
The change from baseline in the negative secondary consequences of alcohol consumption will be measured using the Drinker Inventory of Consequences (DrInC-2R) questionnaire, and will be aggregated using means. The DrInC-2R has a score range from 0 to 150, with higher scores indicating higher consequences.
Time frame: Baseline and six-months follow-up
Change in the severity of the dependency
The change from baseline in the severity of the alcohol use disorder using the Substance Dependence Severity Scale. Means will be used to aggregate participants' DAYS, SEV, and WORST SEV scores for alcohol. The DAYS score varies on an 8-point scale ranging from 0 (symptom did not occur) to 7 (symptom occurred every day of past 30). The SEV and WORST SEV severity variables are scored on a 6-point scale ranging from 0 (absent) to 5 (extreme), with a score of '2' indicating that the diagnostic criterion has been met. Lower scales scores represent less severe dependence, and higher scale scores reflect more severe dependence.
Time frame: Baseline and six-months follow-up
Change in the motivation for change
The change from baseline in the motivational stage measured with the Stages of Change Readiness and Treatment Eagerness Scale-Drug (SOCRATES). The proportion of participants that improve their motivational stage will be used to aggregate the measurement in each group. The SOCRATES scores range within three dimensions: Recognition (7 - 35), Ambivalence (4 - 20), and Taking Steps (8 - 40), with higher scores indicating higher involvement in the dimension.
Time frame: Baseline and six-months follow-up
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