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临床试验/NCT04314115
NCT04314115已完成不适用

Prevention of Mental Health Problems in People Exposed to a Recent Highly Stressful Event: a Randomized Controlled Study

Universidad Santo Tomas, Chile2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
160
试验地点
2
主要终点
Post-traumatic symptoms, post intervention evaluation

研究概览

简要总结

This project evaluates the effectiveness of three intervention models for the prevention of mental health problems in people who have suffered a recent highly stressful event, through an experimental design, with a control group and random assignment of participants in each group .

The preventive interventions that will be evaluated will be based on three different psychotherapeutic models: brief systemic therapy, cognitive behavioral therapy and mindfulness.

It is expected to observe a significant reduction in post-traumatic and depressive symptoms, and an increase in subjective well-being and post-traumatic growth, compared to the control group. In addition, the moderating effect of psychological processes such as cognitive rumination, emotional self-regulation and coping strategies used in the relationship between the type of intervention and its results will be evaluated.

If the hypotheses are confirmed, this study will allow the prevention of emotional distress associated with a highly stressful event, as well as the promotion of positive results, through empirically supported, low-cost strategies and with results that are capable of demonstrating their effectiveness.

详细描述

Highly stressful events are alterations in the life history of an individual that require an adaptation effort. Available studies warn that about 82 to 90% of the general population will be exposed to some type of traumatic event at some time in their lives. Chile, for example, is constantly prone to suffer highly stressful events of massive order, due to the high frequency of natural disasters that affect it from time to time: earthquakes, volcanic eruptions, floods, floods, as well as stressors that individually affect such as criminal violence, sexual abuse or threatening diseases. This makes the probability that a person has to be exposed to an event of this type is high, developing from it various consequences.

Although the majority will not develop long-term negative consequences, a significant percentage may develop different mental health problems, such as post-traumatic symptoms, and depression. It is estimated, for example, that 25% of people exposed to the 2010 Chile earthquake in the Bío Bío region developed a post-traumatic stress disorder. Likewise, 13.5% of adolescents exposed to the same earthquake developed high levels of depressive symptomatology.

However, there are also more adaptive responses after living these events, one of them is to grow from the negative experience. This possibility has been called posttraumatic growth [PTG], defined as the perception of positive changes that a person experiences as a result of the process of fighting a trauma. Although this growth is the result of an event that caused people to feel unwell, which explains the high relationship between PTSD and PTG in some cross-sectional studies, in multivariate studies and longitudinal different predictors are observed, and in prospective studies it has been determined that the highest PTG is associated in the long term with a higher level of well-being and a decrease in posttraumatic and depressive symptomatology, as well as a better quality of life.

Prevention and promotion actions are gaining increasing importance in all areas of the health field, including difficulties that occur in emergencies and post-emergencies. It is therefore important to determine the factors that contribute to a higher level of subjective well-being and PTG or a lower level of post-traumatic or depressive symptoms after experiencing a highly stressful event. Research that has been conducted to determine the predictors of these responses has shown their association with perceived severity, rumination, emotional self-regulation, religious coping or other coping strategies, such as the search for social support and the active coping.

In a study carried out by García in 2016-2017 with people facing a highly stressful event such as an accident at work intrusive rumination, brooding, deliberate rumination were determined as early predictors of posttraumatic symptomatology. Subjective severity of the event, negative religious coping and positive reinterpretation (inverse predictor), brooding, negative religious coping and positive religious coping (reverse predictor) were determined as early predictors of depressive symptomatology. Regarding positive responses, deliberate rumination and positive religious coping were determined as predictors of PTG, but only initial well-being was a predictor of subsequent subjective well-being. The strength of this study is that it evaluated the predictors less than a month after the event occurred, and continued its evolution at six months and one year after the accident occurred. Thus arises the possibility, supported by current empirical data, to develop intervention programs that encourage cognitive reassessment, deliberate rumination on the event, positive religious coping, active coping, the search for social support and initial well-being, in addition to reduce expressive suppression, intrusive and negative rumination, and negative religious confrontation.

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
Single (Investigator)

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

  • Inclusion criteria will be to be of legal age and to have lived the highly stressful experience in the last three months (a check-list of events will be available).

排除标准

  • Those who have already been previously given psychological care will be excluded due to the consequences generated by the same event and who, due to their health condition, are prevented from receiving individual care in the first three months after the event.

结局指标

主要结局

Post-traumatic symptoms, post intervention evaluation

时间窗: Post-intervention evaluation, four weeks after the start of the intervention.

It will be measured with the brief post-traumatic stress disorder qualification interview (SPRINT-E scale) (Norris, Hamblen, Brown \& Schinka, 2008), validated for the Chilean population by Leiva and Gallardo (2013), which has 14 items. Its minimum score is 0 and its maximum score is 36. A higher score means that the patient is worse, due to high post-traumatic symptoms.

Post-traumatic symptoms, follow-up measure

时间窗: Follow-up measurement six months after the end of the intervention.

It will be measured with the brief post-traumatic stress disorder qualification interview (SPRINT-E scale) (Norris, Hamblen, Brown \& Schinka, 2008), validated for the Chilean population by Leiva and Gallardo (2013), which has 14 items. Its minimum score is 0 and its maximum score is 36. A higher score means that the patient is worse, due to high post-traumatic symptoms.

Post-traumatic symptoms, pre-intervention evaluation

时间窗: Pre-intervention evaluation

It will be measured with the brief post-traumatic stress disorder qualification interview (SPRINT-E scale) (Norris, Hamblen, Brown \& Schinka, 2008), validated for the Chilean population by Leiva and Gallardo (2013), which has 14 items. Its minimum score is 0 and its maximum score is 36. A higher score means that the patient is worse, due to high post-traumatic symptoms.

次要结局

  • Depressive symptomatology(A pre-intervention evaluation will be performed before starting the intervention, a post-intervention measurement four weeks later, and a follow-up measurement six months after the end of the intervention.)
  • Posttraumatic growth(A pre-intervention evaluation will be performed before starting the intervention, a post-intervention measurement four weeks later, and a follow-up measurement six months after the end of the intervention.)
  • Subjective well-being(A pre-intervention evaluation will be performed before starting the intervention, a post-intervention measurement four weeks later, and a follow-up measurement six months after the end of the intervention.)

研究者

发起方
Universidad Santo Tomas, Chile
申办方类型
Other
责任方
Principal Investigator
主要研究者

Felipe E. García

Principal investigator

Universidad Santo Tomas, Chile

研究点 (2)

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