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

Primary Purpose

Alcohol Use Disorder

Status

Recruiting

Phase

Not Applicable

Locations

Chile

Study Type

Interventional

Intervention

Brief motivational treatment

Enhanced Usual Care

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Primary care, Alcohol use disorder, Motivational interview

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CESFAM Juan Pablo IIRecruiting
CESFAM Madre Teresa de CalcutaRecruiting
CESFAM San Alberto HurtadoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brief motivational treatment

Enhanced usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Abstinence days

The most extended period of abstinence since enrolment. The number of abstinence days of each participant will be aggregated using means.

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.

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.

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.

Full Information

NCT ID

NCT04345302

First Posted

April 8, 2020

Last Updated

December 20, 2021

Sponsor

Nicolás Barticevic

Collaborators

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

1. Study Identification

Unique Protocol Identification Number

NCT04345302

Brief Title

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

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2021 (Actual)

Primary Completion Date

November 2022 (Anticipated)

Study Completion Date

November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nicolás Barticevic

Collaborators

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Use Disorder

Keywords

Primary care, Alcohol use disorder, Motivational interview

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

Outcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Brief motivational treatment

Arm Type

Experimental

Arm Description

Arm Title

Enhanced usual care

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Brief motivational treatment

Intervention Description

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

Intervention Name(s)

Enhanced Usual Care

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in the Drinks per Drinking Day (DDD)

Description

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

Secondary Outcome Measure Information:

Title

Change in the alcohol use pattern

Description

Time Frame

Baseline and six-months follow-up

Title

Abstinence days

Description

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

Title

Change in the negative consequences of alcohol use

Description

Time Frame

Baseline and six-months follow-up

Title

Change in the severity of the dependency

Description

Time Frame

Baseline and six-months follow-up

Title

Change in the motivation for change

Description

Time Frame

Baseline and six-months follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nicolas A Barticevic, MD

Phone

+56962225043

nabartic@uc.cl

First Name & Middle Initial & Last Name or Official Title & Degree

Diego Quevedo

daqueved@uc.cl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicolas Barticevic, MD

Organizational Affiliation

Adjunct Professor School of Medicine Pontificia Universidad Catolica de Chile

Official's Role

Principal Investigator

Facility Information:

Facility Name

CESFAM Juan Pablo II

City

Santiago

Country

Chile

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Victoria Rodriguez

mvrodriguez1@uc.cl

Facility Name

CESFAM Madre Teresa de Calcuta

City

Santiago

Country

Chile

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pedro Bustos

artrigan@hotmail.com

Facility Name

CESFAM San Alberto Hurtado

City

Santiago

Country

Chile

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Victoria Rodriguez

mvrodriguez1@uc.cl

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The full protocol, dataset, and statistical code are available in the Open Science Foundation repository, DOI 10.17605/OSF.IO/6BA3W

IPD Sharing Time Frame

From protocol registration on.

IPD Sharing Access Criteria

Public

IPD Sharing URL

https://doi.org/10.17605/OSF.IO/6BA3W

Citations:

PubMed Identifier

32736578

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.

Results Reference

derived

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

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