Clinical trial NCT04345302: Brief Motivational Therapy Versus Usual Care for Alcohol Use Disorders in Primary Care.
Official title: Brief Motivational Therapy Versus Enhanced Usual Care for Alcohol Use Disorder in Primary Care in Chile, an Exploratory Randomised Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Primary care
Alcohol use disorder
Motivational interview
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
First posted: 2020-04-14
Enrollment: 182
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a parallel-group, single-blinded, randomized clinical trial to test the superiority of a Brief Motivational Treatment over enhanced usual care. The allocation ratio is 1:1 as per a computer-generated randomisation schedule stratified by site and the baseline SDSS-DAYS score using permuted blocks of random sizes.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of alcohol use disorder according to the DSM-V (American Psychiatric Association, 2013
* Must fulfill criteria for alcohol use disorder and criteria for harmful alcohol use during the last month, i.e., five or more heavy drinking occasions in the last month (5 or more drinks in men, 4 or more in women), or an average use of 14 or more drinks a week in men, and 7 or more in women
* Also, alcohol use should be the main problem motivating participants to seek treatment.

Exclusion Criteria:

* Clients under 20 years old
* Clients in whom alcohol use is not the main problem
* Clients who leave the area or are unable for follow-up contact
* Clients with severe mental comorbidity
* Clients with severe cognitive impairment, illiteracy, or unable to follow treatment in Spanish.
* Clients who are concurrently receiving or planning to receive other psychosocial treatment for alcohol use disorder other than usual care, i.e., formal professional treatment outside of primary care. Participation in community services and Alcoholics Anonymous is permissible.
* Clients who have previously participated in the study, or whose family members are or have been participants.

Primary outcomes:
measure: Change in the Drinks per Drinking Day (DDD)
timeFrame: Baseline and six-months follow-up
Secondary outcomes:
measure: Change in the alcohol use pattern
timeFrame: Baseline and six-months follow-up
measure: Abstinence days
timeFrame: At six-months follow-up
measure: Change in the negative consequences of alcohol use
timeFrame: Baseline and six-months follow-up
measure: Change in the severity of the dependency
timeFrame: Baseline and six-months follow-up
measure: Change in the motivation for change
timeFrame: Baseline and six-months follow-up
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: CESFAM Juan Pablo II
city: Santiago
country: Chile
facility: CESFAM Madre Teresa de Calcuta
city: Santiago
country: Chile
facility: CESFAM San Alberto Hurtado
Study officials:
affiliation: Adjunct Professor School of Medicine Pontificia Universidad Catolica de Chile
name: Nicolas Barticevic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barticevic NA, Poblete F, Zuzulich SM, Rodriguez V, Bradshaw L. Brief motivational therapy versus enhanced usual care for alcohol use disorders in primary care in Chile: study protocol for an exploratory randomized trial. Trials. 2020 Jul 31;21(1):692. doi: 10.1186/s13063-020-04589-4.