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Alcohol Use DisorderNCT04345302

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

A study testing Brief motivational treatment in people with Alcohol Use Disorder, run by Nicolás Barticevic at 3 sites in Chile.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Alcohol Use Disorder
What is being tested?
Brief motivational treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
182 participants
Where
3 sitesChile
Study dates
1 Nov 2021to Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

Nicolas A Barticevic, MD contact

+56962225043

nabartic@uc.cl

Diego Quevedo contact

daqueved@uc.cl

Chile3 sites, 3 recruiting

  • CESFAM Juan Pablo II

    Santiago

    Victoria Rodriguez, mvrodriguez1@uc.cl

    Recruiting

  • CESFAM Madre Teresa de Calcuta

    Santiago

    Pedro Bustos, artrigan@hotmail.com

    Recruiting

  • CESFAM San Alberto Hurtado

    Santiago

    Victoria Rodriguez, mvrodriguez1@uc.cl

    Recruiting

Other trials in Chile

About this study

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

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.

Read the 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).
Being tested
Brief motivational treatment, Enhanced Usual Care
Keywords
Primary care, Alcohol use disorder, Motivational interview
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief motivational treatmentBehavioural

    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 CareBehavioural

    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.

Study groups in NCT04345302
Study groupRoleWhat they receive
Brief motivational treatmentExperimentalParticipants 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.
Receives: Behavioral: Brief motivational treatment; Behavioral: Enhanced Usual Care
Enhanced usual careActive comparatorAll 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.
Receives: Behavioral: Enhanced Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and six-months follow-up

Secondary outcomes (5)

  1. 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.

    Measured: Baseline and six-months follow-up

  2. Abstinence days

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

    Measured: At six-months follow-up

  3. 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.

    Measured: Baseline and six-months follow-up

  4. 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.

    Measured: Baseline and six-months follow-up

  5. 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.

    Measured: Baseline and six-months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2020
  2. Study start1 Nov 2021
  3. Primary completionNov 2022 (estimated)
  4. Study completionNov 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Outcomes assessor
Enrolment
182 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04345302
Sponsor's protocol ID
FONDECYT 11190874
Status last verified
Dec 2021
First submitted
8 Apr 2020
Last updated
11 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The full protocol, dataset, and statistical code are available in the Open Science Foundation repository, DOI 10.17605/OSF.IO/6BA3W

Publications

  • 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.

    PubMed 32736578

Questions about this trial

What is this clinical trial studying?

A study testing Brief motivational treatment in people with Alcohol Use Disorder, run by Nicolás Barticevic at 3 sites in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nicolas A Barticevic, MD (+56962225043, nabartic@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Drinks per Drinking Day (DDD) (time frame: Baseline and six-months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04345302, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.

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