Efficacy of a Brief Poblem-solving Based Psychological Intervention Implemented in Different Formats for the Indicated Prevention of Suicide in Adults Over 50
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- Change from baseline suicidal ideation to post-treatment (7 weeks), and follow-ups at 6 and 12 months.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 50 years old
- •Reside in Galicia
- •Present suicidal ideation
排除标准
- •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.
结局指标
主要结局
Change from baseline suicidal ideation to post-treatment (7 weeks), and follow-ups at 6 and 12 months.
时间窗: Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months
Suicidal ideation will be assessed using the Suicidal Ideation Scale (SSI; Beck et al., 1979), a semi-structured scale of 19 items with an internal consistency (Kuder-Richardson coefficient \[KR-20\]) of .89 and an inter-rater reliability (k) of .83.
次要结局
- Change from baseline reasons for living to post-treatment (7 weeks), and follow-ups at 6 and 12 months(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(Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months)
- Change from baseline hopelessness to post-treatment (7 weeks), and follow-ups at 6 and 12 months(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(Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months)
- Satisfaction with the service received(Post-intervention (7 weeks))
- Change from baseline problem-solving skills to post-treatment (7 weeks), and follow-ups at 6 and 12 months(Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months)
- Treatment adherence(During the intervention sessions (6 weeks)])
- Change from baseline syndrome of clinical anger to post-treatment (7 weeks), and follow-ups at 6 and 12 months(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(Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months)
研究者
Fernando Lino Vázquez González
Full Professor
University of Santiago de Compostela