Brief Motivational Therapy Versus Usual Care for Alcohol Use Disorders in Primary Care.

NCT04345302 | Unknown

• 1 other identifier: FONDECYT 11190874
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 3

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.

Conditions

Alcohol Use Disorder

Keywords

Primary care; Alcohol use disorder; Motivational interview

Outcome Measures

Primary Outcomes (1)

• Change 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.

  Baseline and six-months follow-up

Secondary Outcomes (5)

• Change in the alcohol use pattern

  Baseline and six-months follow-up

• Abstinence days

  At 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

• Change in the motivation for change

  Baseline and six-months follow-up

Study Arms (2)

Brief motivational treatment

EXPERIMENTAL

Participants in the intervention group will receive the Brief Motivational Treatment, which is a primary care-adaptation of the Motivational Enhancement Therapy as manualized in the Project MATCH \[19\]. This treatment consists of four 45-minute sessions, provided by a psychologist at weeks one, two, six, and twelve. The first three sessions, occurring during the first six weeks, are more active regarding the behavioural change, while the last session functions as closure and review of the process. If a participant asks for more support, they will be able to attend up to two extra sessions before the last one. The main adaptations are: * The translation into Chilean Spanish. * Update of Motivational Interview concepts. * Companion training material that includes a demonstrative video and practical exercises. * An adapted personalized feedback procedure. * Information on additional resources available in the primary care centre and the community.

Behavioral: Brief motivational treatment; Behavioral: Enhanced Usual Care

Enhanced usual care

ACTIVE COMPARATOR

All participants will receive an educational brochure on alcohol use disorder, with self-help materials and guides on how to get additional support. The physicians within the PC centre will also receive information on how to diagnose alcohol use disorders, prescription guides for the medications that are available for treating these disorders in the PC centre (mainly Disulfiram and any other if available), and directions on when and where to refer clients for treatment.

Behavioral: Enhanced Usual Care

Interventions

Brief motivational treatment BEHAVIORAL

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.

Brief motivational treatment

Enhanced Usual Care BEHAVIORAL

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.

Brief motivational treatment; Enhanced usual care

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nicolás Barticevic: lead
• Fondo Nacional de Desarrollo Científico y Tecnológico, Chile: collaborator

Study Sites (3)

CESFAM Juan Pablo II

Santiago, Chile

RECRUITING

CESFAM Madre Teresa de Calcuta

Santiago, Chile

RECRUITING

CESFAM San Alberto Hurtado

Santiago, Chile

RECRUITING

Related Publications (1)

• 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.

  PMID: 32736578 DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Nicolas Barticevic, MD

  Adjunct Professor School of Medicine Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas A Barticevic, MD

CONTACT

+56962225043; nabartic@uc.cl

Diego Quevedo

CONTACT

daqueved@uc.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A research assistant blinded to the allocation of the participant will perform the follow-up assessments. Due to the nature of the intervention, the participants and the therapists will know in which group they are participating; however, they will be strongly instructed to not disclose their allocation at the follow-up assessments. At trial closure, a statistician blinded to allocation will conduct the data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 14, 2020
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: January 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: From protocol registration on.
• Access Criteria: Public

Locations

CL (3)