Background

Counselling for Alcohol Problems (CAP), a brief intervention delivered by lay counsellors, enhanced remission and abstinence over 3 months among male primary care attendees with harmful drinking in a setting in India. We evaluated the sustainability of the effects after treatment termination, the cost-effectiveness of CAP over 12 months, and the effects of the hypothesized mediator ‘readiness to change’ on clinical outcomes.

Methods and findings

Male primary care attendees aged 18–65 years screening with harmful drinking on the Alcohol Use Disorders Identification Test (AUDIT) were randomised to either CAP plus enhanced usual care (EUC) (n = 188) or EUC alone (n = 189), of whom 89% completed assessments at 3 months, and 84% at 12 months. Primary outcomes were remission and mean standard ethanol consumed in the past 14 days, and the proposed mediating variable was readiness to change at 3 months. CAP participants maintained the gains they showed at the end of treatment through the 12-month follow-up, with the proportion with remission (AUDIT score < 8: 54.3% versus 31.9%; adjusted prevalence ratio [aPR] 1.71 [95% CI 1.32, 2.22]; p < 0.001) and abstinence in the past 14 days (45.1% versus 26.4%; adjusted odds ratio 1.92 [95% CI 1.19, 3.10]; p = 0.008) being significantly higher in the CAP plus EUC arm than in the EUC alone arm. CAP participants also fared better on secondary outcomes including recovery (AUDIT score < 8 at 3 and 12 months: 27.4% versus 15.1%; aPR 1.90 [95% CI 1.21, 3.00]; p = 0.006) and percent of days abstinent (mean percent [SD] 71.0% [38.2] versus 55.0% [39.8]; adjusted mean difference 16.1 [95% CI 7.1, 25.0]; p = 0.001). The intervention effect for remission was higher at 12 months than at 3 months (aPR 1.50 [95% CI 1.09, 2.07]). There was no evidence of an intervention effect on Patient Health Questionnaire 9 score, suicidal behaviour, percentage of days of heavy drinking, Short Inventory of Problems score, WHO Disability Assessment Schedule 2.0 score, days unable to work, or perpetration of intimate partner violence. Economic analyses indicated that CAP plus EUC was dominant over EUC alone, with lower costs and better outcomes; uncertainty analysis showed a 99% chance of CAP being cost-effective per remission achieved from a health system perspective, using a willingness to pay threshold equivalent to 1 month’s wages for an unskilled manual worker in Goa. Readiness to change level at 3 months mediated the effect of CAP on mean standard ethanol consumption at 12 months (indirect effect −6.014 [95% CI −13.99, −0.046]). Serious adverse events were infrequent, and prevalence was similar by arm. The methodological limitations of this trial are the susceptibility of self-reported drinking to social desirability bias, the modest participation rates of eligible patients, and the examination of mediation effects of only 1 mediator and in only half of our sample.

Conclusions

CAP’s superiority over EUC at the end of treatment was largely stable over time and was mediated by readiness to change. CAP provides better outcomes at lower costs from a societal perspective.

Trial registration

ISRCTN registry ISRCTN76465238

中文翻译：

---

酒精问题咨询的持续有效性和成本效益，一种针对男性有害饮酒的简短心理治疗，由初级保健领域的非专业咨询师提供：一项随机对照试验的 12 个月随访

背景

酒精问题咨询 (CAP) 是由非专业顾问提供的一项简短干预，在印度某环境中，在 3 个月内提高了有害饮酒男性初级保健参与者的缓解和戒酒。我们评估了治疗终止后效果的可持续性、CAP 在 12 个月内的成本效益，以及假设的中介“准备改变”对临床结果的影响。

方法和发现

在酒精使用障碍识别测试 (AUDIT) 中筛查有害饮酒的 18-65 岁男性初级保健参与者被随机分配到 CAP 加增强常规护理 (EUC) ( n = 188) 或仅 EUC ( n = 189)，其中 89% 在 3 个月时完成了评估，84% 在 12 个月时完成了评估。主要结果是过去 14 天的缓解情况和平均标准乙醇消耗量，建议的中介变量是 3 个月时改变的准备情况。CAP 参与者在 12 个月的随访中保持了他们在治疗结束时表现出的收益，缓解的比例（AUDIT 评分 < 8：54.3% 对 31.9%；调整后患病率 [aPR] 1.71 [95% CI 1.32 , 2.22]; p <0.001）和过去 14 天的禁欲（45.1% 对 26.4%；调整后的优势比 1.92 [95% CI 1.19, 3.10]；p = 0.008）在 CAP 加 EUC 组中显着高于仅在 EUC 组中。CAP 参与者在次要结局方面的表现也更好，包括康复（3 个月和 12 个月的 AUDIT 评分 < 8：27.4% 对 15.1%；aPR 1.90 [95% CI 1.21, 3.00]；p = 0.006）和禁欲天数百分比（平均百分比[SD] 71.0% [38.2] 与 55.0% [39.8]；调整后的平均差 16.1 [95% CI 7.1, 25.0]；p =0.001)。12 个月时缓解的干预效果高于 3 个月时（aPR 1.50 [95% CI 1.09, 2.07]）。没有证据表明干预对患者健康问卷 9 得分、自杀行为、大量饮酒天数百分比、问题清单简短得分、WHO 残疾评估表 2.0 得分、无法工作的天数或亲密伴侣暴力行为有影响。经济分析表明 CAP 加 EUC 优于单独的 EUC，成本更低，结果更好；不确定性分析表明，从卫生系统的角度来看，CAP 具有成本效益的可能性为 99%，使用意愿支付门槛相当于果阿非熟练体力工人 1 个月的工资。3 个月时改变水平的准备程度介导了 CAP 对 12 个月时平均标准乙醇消耗量的影响（间接影响 -6.014 [95% CI -13.99, -0.046]）。严重的不良事件并不常见，各组的患病率相似。该试验的方法学限制是自我报告的饮酒对社会期望偏差的敏感性、符合条件的患者的适度参与率以及仅在我们的样本中仅对 1 个中介的中介效应的检查。

结论

在治疗结束时，CAP 对 EUC 的优势在很大程度上随着时间的推移而稳定，并且受改变意愿的影响。从社会角度来看，CAP 以更低的成本提供更好的结果。

试用注册

ISRCTN注册ISRCTN76465238