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基线参与者特征是否会影响针对抑郁症状的移动健康干预的效果?CONEMO 试验的事后亚组分析。

Do baseline participant characteristics impact the effectiveness of a mobile health intervention for depressive symptoms? A post-hoc subgroup analysis of the CONEMO trials.

机构信息

Faculdade de Enfermagem, Universidade Estadual de Campinas, Campinas, SP, Brazil. Núcleo de Apoio à Pesquisa em Saúde Mental Populacional, Universidade de São Paulo (USP), São Paulo, SP, Brazil.

Núcleo de Apoio à Pesquisa em Saúde Mental Populacional, Universidade de São Paulo (USP), São Paulo, SP, Brazil. Departamento de Medicina Preventiva, Faculdade de Medicina, USP, São Paulo, SP, Brazil.

出版信息

Braz J Psychiatry. 2024;46:e20233172. doi: 10.47626/1516-4446-2023-3172. Epub 2024 Jan 30.

Abstract

OBJECTIVE

To ascertain whether sociodemographic and health-related characteristics known from previous research to have a substantive impact on recovery from depression modified the effect of a digital intervention designed to improve depressive symptoms (CONEMO).

METHODS

The CONEMO study consisted of two randomized controlled trials, one conducted in Lima, Peru, and one in São Paulo, Brazil. As a secondary trial plan analysis, mixed logistic regression was used to explore interactions between the treatment arm and subgroups of interest defined by characteristics measured before randomization - suicidal ideation, race/color, age, gender, income, type of mobile phone, alcohol misuse, tobacco use, and diabetes/hypertension - in both trials. We estimated interaction effects between the treatment group and these subgroup factors for the secondary outcomes using linear mixed regression models.

RESULTS

Increased effects of the CONEMO intervention on the primary outcome (reduction of at least 50% in depressive symptom scores at 3-month follow-up) were observed among older and wealthier participants in the Lima trial (p = 0.030 and p = 0.001, respectively).

CONCLUSION

There was no evidence of such differential effects in São Paulo, and no evidence of impact of any other secondary outcomes in either trial.

CLINICAL TRIAL REGISTRATION

NCT02846662 (São Paulo, Brazil - SP), NCT03026426 (Lima, Peru - LI).

摘要

目的

确定先前研究中已知对抑郁康复具有实质性影响的社会人口学和健康相关特征是否改变了旨在改善抑郁症状的数字干预(CONEMO)的效果。

方法

CONEMO 研究包括两项随机对照试验,一项在秘鲁利马进行,另一项在巴西圣保罗进行。作为二次试验计划分析,混合逻辑回归用于探索治疗组与随机分组前测量的特征(自杀意念、种族/肤色、年龄、性别、收入、手机类型、酒精滥用、吸烟和糖尿病/高血压)定义的感兴趣亚组之间的相互作用。我们使用线性混合回归模型估计了这两个试验中治疗组与这些亚组因素之间的次要结局的相互作用效应。

结果

在利马试验中,年龄较大和收入较高的参与者中观察到 CONEMO 干预对主要结局(抑郁症状评分在 3 个月随访时至少降低 50%)的效果增强(p=0.030 和 p=0.001)。

结论

在圣保罗没有发现这种差异效应的证据,也没有发现任何其他次要结局的影响的证据。

临床试验注册

NCT02846662(巴西圣保罗-SP),NCT03026426(秘鲁利马-LI)。

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