Spanish journal of psychiatry and mental health · 2023
Safety intervention for improving functioning in suicidal attempters (STRONG): A secondary prevention study. Study rationale and research protocol.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод пока не подготовлен
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Roberto Natalia, Vazquez Mireia, Radua Joaquim, Pariente Jose Carlos, Muñoz-Moreno Emma, Laredo Carlos, Bracco Lorenzo, Fernández Tábatha, Martín-Parra Sara, Martínez-Aran Anabel, Sánchez-Moreno Jose, Saiz Pilar, Ruiz-Veguilla Miguel, Borras Roger, Toll Alba, Elices Matilde, Brambilla Paolo, Courtet Philippe, Perez-Solà Víctor, Vieta Eduard, Grande Iria
Аннотация
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.
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.