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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-11-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Brief motivational treatment

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.

Group Type EXPERIMENTAL

Brief motivational treatment

Intervention Type 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.

Enhanced Usual Care

Intervention Type 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.

Enhanced usual care

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.

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type 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.

Interventions

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Brief motivational treatment

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.

Intervention Type BEHAVIORAL

Enhanced Usual Care

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No