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临床试验/NCT00169884
NCT00169884Unknown2 期

The Efficacy of a Cognitive-Behavioural Intervention in Deliberate Self-Harm Patients: A Randomized Controlled Trial Among Adolescents and Young Adults

Leiden University Medical Center2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2002年3月1日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
120
试验地点
2
主要终点
repetition of DSH

研究概览

简要总结

The purpose of this study is to evaluate whether the proposed cognitive-behavioural intervention is effective for DSH patients in the age group 15-35 years. In addition, we will examine which elements derived from the theoretical model can explain the efficacy of the intervention.

详细描述

  1. The development of treatment interventions for non-fatal deliberate self-harm (DSH) among young people has received little attention in scientific literature and in mental health care. This is surprising, considering the relatively high rates of hospital-referred DSH among adolescents reported in epidemiological studies (Arensman et al., 1995; Hawton et al., 1997; Hawton et al., 1998; Schmidtke et al., 1996). On the basis of a four-year monitoring study (1989-1992) in the area of Leiden, the average rate of DSH among females aged 15-24 was 179 per 100,000 and for males in this age group the average rate was 91 per 100,000 (Arensman et al., 1995). General population surveys among adolescents show a self-reported life-time prevalence of 2 to 5 percent (Kienhorst et al., 1990; De Wilde et al., 2000). Reports from other European countries indicate an increase of DSH in adolescents and young adults (15-30 years), in particular in young males (Hawton et al., 1997; Schmidtke et al., 1996).

DSH is operationalized as dysfunctional behaviour associated with a heterogeneity of psychological or psychiatric disorders e.g., affective disorders, anxiety disorders, substance abuse, and eating disorders (Arensman & Kerkhof, 1996; Arensman, 1997; Ellis et al., 1996; Engstroem et al., 1996; Kienhorst et al., 1993). However, a common finding is that depressive symptoms (observer- or self-rated) and major depression appear to be highly prevalent among young DSH patients (Burgess et al., 1998; Goldston et al., 1998; Harrington et al., 1994). In these studies, co-morbidity with other types of psychopathology also appeared to be relatively high.

The risk of repeated DSH is highest in the first year following an episode of DSH. The repetition rates among young DSH patients vary from 10% (Goldacre & Hawton, 1985) to 27% (Arensman, 1997) in hospital referred DSH patients. Among DSH patients, prevention of the first subsequent repeated episode of DSH is important in order to prevent a pattern of chronic repetition.

Research findings with regard to risk factors associated with repeated DSH are fairly consistent. Among young DSH patients, those with an increased risk for repeated DSH are characterised by suicidal ideation, depression (Harrington et al., 2000; Hawton et al., 1999), hopelessness (Brent, 1987; Hawton et al., 1999), impulsivity (Kashden et al., 1993), disturbance of autobiographical memory (Evans et al., 1992), problems with peers or other relationships, frequent or chronic stress and problem-solving deficits (De Wilde et al., 2000; Hawton et al., in press; Rudd et al., 1998).

Despite the fact that many studies report these correlates, the available treatment studies, which merely comprise evaluations of general treatment interventions, often without a randomised controlled design, have not incorporated knowledge about risk factors (Hawton et al., 1998). In addition, existing explanatory and treatment models do not address the heterogeneity of the group of DSH patients. This is surprising, considering the variety of characteristics and problems of DSH patients. So far, most models focus on single psychiatric problems, such as depression or anxiety disorders.

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

入排标准

年龄范围
15 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • DSH patients will be included if they recently have been engaged in an act of DSH including overdoses of medication, ingestion of chemical substances and self-inflicted injuries according to the definition which is used in the WHO/Euro Multicentre Study on parasuicide: "An act with non-fatal outcome in which an individual deliberately initiates a non-habitual behaviour, that without intervention from others will cause self-harm, or deliberately ingests a substance in excess of the prescribed or generally recognised dosage, and which is aimed at realising changes that the person desires via the actual or expected physical consequences" (Platt et al., 1992). In addition, only DSH patients aged 15-35 will be included.

排除标准

  • DSH patients with severe psychiatric disorders requiring intensive long-term psychiatric treatment, such as schizophrenia, will be excluded.

结局指标

主要结局

repetition of DSH

次要结局

  • psychiatric diagnosis, depression, hopelessness, suicidal intent, suicidal cognitions, self-concept, (cognitive) coping, emotion regulation difficulties, impulsivity, social support, hostility, personality disorder related beliefs and attachment style.

研究者

发起方
Leiden University Medical Center
申办方类型
Other

研究点 (2)

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