Safety intervention for improving functioning in suicidal attempters (STRONG): A secondary prevention study. Study rationale and research protocol

IF 2.6 0 PSYCHIATRY
Natalia Roberto , Mireia Vazquez , Joaquim Radua , Jose Carlos Pariente , Emma Muñoz-Moreno , Carlos Laredo , Lorenzo Bracco , Tábatha Fernández , Sara Martín-Parra , Anabel Martínez-Aran , Jose Sánchez-Moreno , Pilar Saiz , Miguel Ruiz-Veguilla , Roger Borras , Alba Toll , Matilde Elices , Paolo Brambilla , Philippe Courtet , Víctor Perez-Solà , Eduard Vieta , Iria Grande
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引用次数: 0

Abstract

Background

Suicide is one of the most largely preventable causes of death worldwide. The aim of the STRONG study is to assess the effectiveness of a specific intervention (an extended Safety Planning Intervention) called iFightDepression-SURVIVE (iFD-S) in suicidal attempters by changes in psychosocial functioning. As secondary outcomes, quality of life, cognitive performance, clinical state and neuroimaging correlates will be considered.

Objective

To describe the rationale and design of the STRONG study, an extension of the SURVIVE study, a national multicenter cohort about on prevention in suicidal attempters.

Methods

The STRONG study is a two-year clinical trial. A total sample of 60 patients will be randomly allocated to two arms: a group will receive a iFD-S and treatment as usual (TAU) (n = 30 treatment group), while another group will exclusively receive TAU (n = 30 control group). There will be three study points: baseline; 3-month; and 6-month follow-up assessments, all of which will include rater-blinded evaluation of psychosocial functioning, quality of life, clinical state, cognitive performance and neuroimaging acquisition.

Results

It is expected to obtain data on the efficacy of iFD-S in patients who have committed a suicide attempt.

Conclusion

Results will provide insight into the effectiveness of IFD-S in suicidal attempters with respect to improvements in psychosocial functioning, quality of life, cognition, and neuroimaging correlates.

Clinical trials ID

NCT05655390.
改善自杀企图者功能的安全干预(STRONG):二级预防研究。研究原理和研究方案。
背景:自杀是全球最主要的可预防死因之一。STRONG研究的目的是通过社会心理功能的变化来评估一种名为iFightDepression-SURVIVE(iFD-S)的特定干预措施(一种扩展的安全规划干预措施)对自杀企图者的有效性。作为次要结果,还将考虑生活质量、认知能力、临床状态和神经影像学相关因素:描述 STRONG 研究的原理和设计,该研究是 SURVIVE 研究的延伸,是一项关于预防自杀企图者的全国性多中心队列研究:STRONG 研究是一项为期两年的临床试验。方法:STRONG 研究是一项为期两年的临床试验,总共 60 名患者将被随机分配到两组:一组将接受 iFD-S 和常规治疗(TAU)(治疗组 30 人),另一组将只接受 TAU(对照组 30 人)。研究将分为三个阶段:基线评估、3 个月评估和 6 个月随访评估,所有评估都将包括社会心理功能、生活质量、临床状态、认知表现和神经影像学采集等方面的评分者盲法评估:预计将获得 iFD-S 对自杀未遂患者的疗效数据:临床试验 ID:NCT05655390:NCT05655390。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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CiteScore
9.50
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