Brief Problem-solving Intervention in Different Formats for the Prevention of Suicide in Adults Over 50

Официальное название

Efficacy of a Brief Poblem-solving Based Psychological Intervention Implemented in Different Formats for the Indicated Prevention of Suicide in Adults Over 50

Обзор

Suicide represents a personal tragedy and an enormous global public health problem. One of the most vulnerable groups is adults 50 years and older. Despite this stage of life is particularly amenable to the implementation of targeted suicide prevention strategies, we have few studies of the efficacy of psychological interventions, those that do exist have methodological limitations, and none were implemented in formats other than face-to-face, which limits their accessibility. There is a need for brief psychological interventions that can be administered in both face-to-face and remote formats, do not require long training periods, and are effective in different contexts: for example, problem-solving therapy. The main objective of this project is to evaluate the efficacy of a brief problem-solving psychological intervention for targeted suicide prevention in people aged 50 years and older, administered in face-to-face, conference call, and smartphone app formats. A randomized controlled trial will be performed. Participants will be recruited through healthcare centers in the Autonomous Community of Galicia (Spain). To be included, participants must: (a) be at least 50 years old, (b) reside in Galicia, and (c) present suicidal ideation. Subjects will be excluded if they: (a) present serious mental health or medical disorders; (b) have begun receiving psychological or psychopharmacological treatment in the previous two months or are participating in other suicide prevention research; (c) do not have an appropriate mobile device or sufficient fluency to communicate in Spanish, or have problems that make it impossible to participate; or (d) plan to move in the next 18 months. At pre-intervention information will be collected on sociodemographic, family, personal history, current suicide risk and other clinical variables. 212 participants will be randomly assigned to (1) a problem-solving-based psychological intervention delivered face-to-face (PSPI-FF; experimental group 1); (2) a problem-solving-based psychological intervention delivered via telephone conference call (PSPI-CC; experimental group 2); (3) a problem-solving-based psychological intervention delivered via a smartphone app (PSPI-A; experimental group 3); or (4) a usual care control group (UCCG). Participants in the experimental groups will complete the six sessions/modules of the interventions. Finally, subjects in all groups will be evaluated at post-intervention and 3, 6 and 12-month follow-ups.

Вмешательства

• Поведенческое Problem-solving-based psychological intervention
  The intervention will include training in the components of the problem-solving model and other behavioral and cognitive skills such as detecting warning signals, monitoring mood, relaxation techniques, self-reinforcement, strategies for acting in crisis situations, engaging in enjoyable activities, mindfulness meditation techniques, or strategies for reframing irrational thoughts. It will be developed from the problem-solving model (D'Zurilla and Nezu, 1982) and will reference the indicated pre

Первичные конечные точки

• Change from baseline suicidal ideation to post-treatment (7 weeks), and follow-ups at 6 and 12 months. [Срок оценки: Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months]
• Change from baseline suicidal ideation to post-treatment (7 weeks), and follow-ups at 6 and 12 months. [Срок оценки: Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months]

Вторичные конечные точки (9)

• Change from baseline hopelessness to post-treatment (7 weeks), and follow-ups at 6 and 12 months [Срок оценки: Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months]
• Change from baseline anxiety and depressive symptoms to post-treatment (7 weeks), and follow-ups at 6 and 12 months [Срок оценки: Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months]
• Change from baseline reasons for living to post-treatment (7 weeks), and follow-ups at 6 and 12 months [Срок оценки: Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months]
• Change from baseline impulsivity to post-treatment (7 weeks), and follow-ups at 6 and 12 months [Срок оценки: Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months]
• Change from baseline problem-solving skills to post-treatment (7 weeks), and follow-ups at 6 and 12 months [Срок оценки: Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months]
• Change from baseline social support to post-treatment (7 weeks), and follow-ups at 6 and 12 months [Срок оценки: Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months]
• Change from baseline syndrome of clinical anger to post-treatment (7 weeks), and follow-ups at 6 and 12 months [Срок оценки: Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months]
• Treatment adherence [Срок оценки: During the intervention sessions (6 weeks)]]
• Satisfaction with the service received [Срок оценки: Post-intervention (7 weeks)]

Критерии участия

Критерии включения

• Be at least 50 years old
• Reside in Galicia
• Present suicidal ideation

Критерии исключения

• Present serious mental health or medical disorders
• Have begun receiving psychological or psychopharmacological treatment in the previous two months or are participating in other suicide prevention research
• Do not have an appropriate mobile device or sufficient fluency to communicate in Spanish, or have problems that make it impossible to participate
• Plan to move in the next 18 months.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Испания · 1 центр

• Research Group on Mental Health and Psychopatology — Santiago de Compostela

Публикации

• D'Zurilla TJ, Nezu, A. Social problem solving in adults. In: Kendall PC (editor). Advances in cognitive-behavioral research on therapy. New York: Academic Press; 1982. vol. 1, p. 202-74.
• Vázquez FL, Otero P, Blanco V, Torres AJ. Terapia de solución de problemas para la depresión: una breve guía práctica en grupo. Madrid: Alianza Editorial. 2015.
• Otero P, Smit F, Cuijpers P, Torres A, Blanco V, Vazquez FL. Long-term efficacy of indicated prevention of depression in non-professional caregivers: randomized controlled trial. Psychol Med. 2015 May;45(7):1401-12. doi: 10.1017/S0033291714002505. Epub 2014 Oct 21. PMID 25331992
• Vazquez Gonzalez FL, Otero Otero P, Torres Iglesias A, Hermida Garcia E, Blanco Seoane V, Diaz Fernandez O. A brief problem-solving indicated-prevention intervention for prevention of depression in nonprofessional caregivers. Psicothema. 2013 Feb;25(1):87-92. doi: 10.7334/psicothema2012.89. PMID 23336549
• Lopez L, Smit F, Cuijpers P, Otero P, Blanco V, Torres A, Vazquez FL. Problem-solving intervention to prevent depression in non-professional caregivers: a randomized controlled trial with 8 years of follow-up. Psychol Med. 2020 Apr;50(6):1002-1009. doi: 10.1017/S0033291719000916. Epub 2019 Apr 24. PMID 31017076
• Xavier A, Otero P, Blanco V, Vazquez FL. Efficacy of a problem-solving intervention for the indicated prevention of suicidal risk in young Brazilians: Randomized controlled trial. Suicide Life Threat Behav. 2019 Dec;49(6):1746-1761. doi: 10.1111/sltb.12568. Epub 2019 Jun 25. PMID 31237377
• Beck AT, Kovacs M, Weissman A. Assessment of suicidal intention: the Scale for Suicide Ideation. J Consult Clin Psychol. 1979 Apr;47(2):343-52. doi: 10.1037//0022-006x.47.2.343. No abstract available. PMID 469082
• Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704. PMID 22193671

Идентификаторы

NCT: NCT06338904 · PID2022-141225OB-I00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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