Brief Motivational Therapy Versus Enhanced Usual Care for Alcohol Use Disorder in Primary Care in Chile, an Exploratory Randomised Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 182
- 试验地点
- 3
- 主要终点
- Change in the Drinks per Drinking Day (DDD)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Brief motivational treatment (Behavioral)
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.
干预措施: Enhanced Usual Care (Behavioral)
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.
干预措施: Enhanced Usual Care (Behavioral)
结局指标
主要结局
Change in the Drinks per Drinking Day (DDD)
时间窗: 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.
次要结局
- 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)
研究者
Nicolás Barticevic
Principal Investigator
Pontificia Universidad Catolica de Chile