Individuals who are ‘moderately’ or ‘severely’ dependent consume alcohol at levels that are likely to have a severe impact on their own health and mortality, the health and behaviours of others (family members) and to have economic and social implications. Treatment guidelines suggest that treatment needs to be planned with medically assisted withdrawal (also referred to as detoxification), and aftercare support but outcomes are poor with low proportions engaging in after care and high relapse rates. An approach of structured preparation before alcohol detoxification (SPADe) puts an emphasis on introducing lifestyle changes, development of coping strategies for cravings, stress and emotions as well as introducing changes to the immediate family and social environment in advance of alcohol cessation. Such a pre-habilitation paradigm compliments the established treatment approach. The key research question was: can we design a large scale, randomised controlled trial (RCT) that will answer whether such an approach is more effective than usual care in helping individuals to maintain longer periods of alcohol abstinence? This is a pragmatic, parallel, two-arm, feasibility RCT comparing SPADe and usual care against usual care only in maintaining alcohol abstinence in adults with alcohol dependence receiving care in two community addiction services in London. Feasibility outcomes, exploration of primary and secondary clinical outcomes and health economic outcomes are analysed. The trial follows the guidelines of phase 2 of the Medical Research Council (MRC) for complex interventions. We were able to recruit 48/50 participants during a period of 9 months. Retention in the trial for the whole period of the 12 months was 75%. Treatment compliance was overall 44%. Data completion for the primary outcome was 65%, 50% and 63% at 3, 6 and 12 months, respectively. The intervention group had more days abstinent in the previous 90 days at the 12 months (n = 54.5) versus control (n = 41.5). The results of this feasibility trial indicate that with the appropriate modifications, a full multicentred trial would be possible to test the effectiveness and cost-effectiveness of a pre-habilitation approach such as the SPADe group intervention in addition to usual care against usual care only. Name of registry: ISRCTN; Trial Registration Number: 14621127 ; Date of Registration: 22/02/2017.

中文翻译：

---

戒毒前结构化准备与常规护理干预酒精依赖的可行性试验：SPADe 试验结果


“中度”或“严重”依赖的个人的饮酒水平可能对其自身健康和死亡率、他人（家庭成员）的健康和行为产生严重影响，并产生经济和社会影响。治疗指南建议，治疗需要通过医疗辅助戒断（也称为戒毒）和术后护理支持来规划，但结果较差，参与术后护理的比例较低，且复发率较高。酒精戒毒前的结构化准备（SPADe）方法强调改变生活方式，制定应对渴望、压力和情绪的策略，以及在戒酒之前改变直系亲属和社会环境。这种预康复模式与既定的治疗方法相得益彰。关键的研究问题是：我们能否设计一项大规模的随机对照试验（RCT）来回答这种方法是否比常规护理更有效地帮助个人维持更长时间的戒酒？这是一项务实、平行、双臂、可行性随机对照试验，将 SPADe 和常规护理与常规护理仅在维持伦敦两个社区成瘾服务机构接受护理的酒精依赖成人的戒酒方面进行比较。分析了可行性结果、主要和次要临床结果的探索以及健康经济结果。该试验遵循医学研究委员会（MRC）第二阶段复杂干预措施的指导方针。我们在 9 个月内招募了 48/50 名参与者。整个 12 个月试验期间的保留率为 75%。治疗依从性总体为 44%。 3、6 和 12 个月时主要结局的数据完成率分别为 65%、50% 和 63%。与对照组 (n = 41.5) 相比，干预组在 12 个月的前 90 天内戒酒的天数 (n = 54.5) 更多。该可行性试验的结果表明，通过适当的修改，可以进行全面的多中心试验，以测试除常规护理之外的预康复方法（例如 SPADe 小组干预）的有效性和成本效益。注册机构名称：ISRCTN；试用注册号：14621127；注册日期：2017 年 2 月 22 日。