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Clinical Trials/NCT04345302
NCT04345302
Unknown
Not Applicable

Brief Motivational Therapy Versus Enhanced Usual Care for Alcohol Use Disorder in Primary Care in Chile, an Exploratory Randomised Trial

Nicolás Barticevic3 sites in 1 country182 target enrollmentNovember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alcohol Use Disorder
Sponsor
Nicolás Barticevic
Enrollment
182
Locations
3
Primary Endpoint
Change in the Drinks per Drinking Day (DDD)
Last Updated
4 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
November 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nicolás Barticevic
Responsible Party
Sponsor Investigator
Principal Investigator

Nicolás Barticevic

Principal Investigator

Pontificia Universidad Catolica de Chile

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.

Outcomes

Primary Outcomes

Change in the Drinks per Drinking Day (DDD)

Time Frame: Baseline and six-months follow-up

The change from baseline in the DDD during the last 90 days. The DDD will be aggregated using means.

Secondary Outcomes

  • Change in the alcohol use pattern(Baseline and six-months follow-up)
  • Change in the negative consequences of alcohol use(Baseline and six-months follow-up)
  • Change in the severity of the dependency(Baseline and six-months follow-up)
  • Abstinence days(At six-months follow-up)
  • Change in the motivation for change(Baseline and six-months follow-up)

Study Sites (3)

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