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临床试验/NCT04284085
NCT04284085已完成不适用

Evaluation of a Psychoeducational Intervention for People With Suicidal Behaviour in the Penitentiary Environment. N'VIU Project

Consorci Hospitalari de Vic2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2019年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
2
主要终点
Number of suicidal behaviours

研究概览

简要总结

Objective. The main objective is to determine the effectiveness of a psychoeducational program conducted by rehabilitation professionals to reduce the number of suicidal behaviors in prisons.

Methodology. The design of the study will be a multicenter, randomized, two-group clinical trial with blind evaluation of response variables, one year follow-up. The study population will be a male and female prison population of a total of two Catalan prisons. As a dependent or outcome variable, the total number of suicidal behaviors recorded for 12 months after the intervention will be determined. As independent variables, socio-demographic, clinical and prison situation variables will be collected. The suicidal ideation will be measured with the Columbia-Suicide Severity Rating Scale (C-SSRS). The anxiety and depression with Hamilton scale for assessing anxiety (HDRS) and the Hamilton scale for assessing severity of depressive symptoms (HAM-D). The EuroQoL-5D Health Questionnaire (EQ-5D) to measure quality of life. And a satisfaction survey of psychoeducational group intervention. Participants who meet the inclusion criteria will be divided into two groups, an intervention group that will conduct group sessions with a frequency of two per week and duration of 90 minutes for a total of 13 sessions, and a control group that will receive information on suicide counseling.

Discussion. Mortality from suicide is higher in the prison population than in the general population. This project aims to evaluate the effect of a psychoeducational intervention on reducing the number of suicidal behaviors in prison, in order to evaluate their implementation at the level of the entire prison network.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • People who have attempted suicide or a risk of suicide moderate to high.

排除标准

  • People with a mental disorder in a state of acute exacerbation
  • Intellectual disability
  • Cognitive impairment

结局指标

主要结局

Number of suicidal behaviours

时间窗: 12 months

Total number of suicidal behaviors recorded during 12 months after the start of the study in both groups.

次要结局

  • Levels of depression(6 months)
  • Severity of suicidal ideation(6 months)
  • Levels of Anxiety(6 months)
  • Level of Quality of life: EuroQoL-5D Health Questionnaire, EQ-5D(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Pere Roura-Poch

Head of epidemiology

Consorci Hospitalari de Vic

研究点 (2)

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