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结构化团体心理教育对卢旺达双相情感障碍患者的疗效:一项随机开放标签优效性试验。

Effectiveness of structured group psychoeducation for people with bipolar disorder in Rwanda: A randomized open-label superiority trial.

机构信息

Center for Global Health, Department of Public Health, Aarhus University, Denmark; College of Medicine and Health Sciences University of Rwanda, Rwanda.

Center for Global Health, Department of Public Health, Aarhus University, Denmark; College of Medicine and Health Sciences University of Rwanda, Rwanda; Mental Health Department, University Teaching Hospital of Kigali, Rwanda.

出版信息

J Affect Disord. 2024 Jul 1;356:405-413. doi: 10.1016/j.jad.2024.04.071. Epub 2024 Apr 18.

DOI:10.1016/j.jad.2024.04.071
PMID:38640974
Abstract

BACKGROUND

Psychoeducation is a cornerstone as an add-on to pharmacotherapy in standard care for individuals with bipolar disorder. However, evidence of the effectiveness of psychoeducation in low-resource settings is scarce.

AIMS

We aimed to assess the effectiveness of structured group psychoeducation versus waiting list on relapse prevention for individuals with bipolar disorder in Rwanda, a low-income country.

METHODS

This was a randomized open-label superiority trial. Participants aged 18 years or older with bipolar disorder were recruited at the two referral hospitals for mental health in Rwanda and randomly assigned 12 sessions of group psychoeducation or a waiting list. The program was tailored to the setting and co-designed with patients and clinicians. The follow-up period was 12 months, and the primary outcome mean number of psychiatric hospitalizations.

RESULTS

In February and March 2021, 154 participants were randomly assigned to receive group psychoeducation (n = 78) or to a waiting list (n = 76). The retention rate was high, with only three discontinuing the psychoeducation once they had received a session. Despite limited use of first-line pharmacotherapy, the psychoeducation reduced the risk of hospitalization by half during the 12-month follow-up (RR: 0.50(95 % CI 0.26-0.95)). Yet, no change in medical adherence was observed.

LIMITATION

Weekly assessment of clinical status was not feasible.

CONCLUSION

Structured group psychoeducation for bipolar disorder in a low-resource setting has a protective effect against readmission despite limited access to first-line pharmacotherapy. Further studies are needed to assess the effectiveness of the program in more decentralized settings with less highly trained staff.

TRIAL REGISTRATION

NCT04671225.

摘要

背景

心理教育是双相情感障碍标准治疗中药物治疗的附加内容,是基石。然而,在资源匮乏环境下心理教育有效性的证据却很少。

目的

我们旨在评估结构化团体心理教育对卢旺达(低收入国家)双相情感障碍患者预防复发的效果,卢旺达资源匮乏。

方法

这是一项随机开放标签优效性试验。在卢旺达两家精神卫生转诊医院招募年龄在 18 岁及以上的双相情感障碍患者,并将其随机分配到团体心理教育组(12 次课程)或候补名单组。该方案是根据环境量身定制的,并与患者和临床医生共同设计。随访期为 12 个月,主要结局为平均住院次数。

结果

2021 年 2 月和 3 月,154 名参与者被随机分配接受团体心理教育(n=78)或候补名单(n=76)。保留率很高,只有 3 名参与者在接受一次治疗后就退出了心理教育。尽管一线药物治疗的使用率有限,但心理教育在 12 个月的随访中使住院风险降低了一半(RR:0.50(95%CI 0.26-0.95))。然而,药物治疗的依从性并没有改变。

局限性

每周评估临床状况是不可行的。

结论

在资源匮乏环境下,结构化团体心理教育对双相情感障碍具有保护作用,尽管一线药物治疗的可及性有限。需要进一步研究来评估该方案在具有较少高技能工作人员的更加分散的环境中的有效性。

试验注册

NCT04671225。

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