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临床试验/NCT06099561
NCT06099561招募中不适用

Svårbehandlat självskadebeteende-Vilka Insatser är Effektiva?

Region Skane1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
Region Skane
入组人数
30
试验地点
1
主要终点
The World Health Organization Disability Assessment Schedule II (WHODAS 2.0)

研究概览

简要总结

The aim of this project is to evaluate a novel treatment program for individuals with intractable and lethal self-harm.

The main questions are:

1: Is there, in individuals with intractable self-harm, a relevant improvement in daily functioning and is this improvement related to the provided interventions?

The secondary research questions are:

2. Is there, in individuals with intractable self-harm, a relevant improvement in frequency and severity of self-harm?

3. Is there, in individuals with intractable self-harm, a relevant improvement in voluntary hospital admissions?

4. Is there, in individuals with intractable self-harm, a relevant improvement in compulsary hospital admissions?

5. Is there, in individuals with intractable self-harm, a relevant improvement in the use of medication pro re nata?

6. Is there, in individuals with intractable self-harm, a relevant improvement in cost-effectiveness related to the provided interventions?

详细描述

Individuals with intractable, imminent and lethal self-harm often have multifaceted psychiatric symptoms, pervasive suffering, high mortality and a reduced level of daily functioning. Severe self-harm can lead to long periods of psychiatric inpatient care which can lead to reduced autonomy and aggravated self-harm. Effects of this care remain uncertain. The Swedish National Board of Welfare has provided National specialized medical care units for severe self-harm behaviour to three Swedish hospitals.

In one of this hospitals, Region Skåne, the intervention will be consultation-based. Individuals with intractable self-harm will be offered an assessment and review of all medical records which will result in a individualized intervention plan. Interventions include further assessments and supporting the existing treatment providers, families or caregivers. Recurring network-meetings will occur every three months as well as at he end of the intervention.

Data collection will include self-report measures as well as information from charts and national och regional registries.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

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

入选标准

  • •Having tried or made serious attempt to try at least two different interventions with evidence to reduce self-harm, without sufficient reduction in suffering or self-harm

排除标准

  • •Need for translation services to complete measures or interviews
  • •Not able to complete measures or interviews

研究组 & 干预措施

Study group

Individuals with current severe, imminent and lethal self-harm with a history of at least two interventions without sufficient reduction of self-harm or suffering.

干预措施: National specialized medical care unit for severe self-harm behaviour-Consultation model (Behavioral)

结局指标

主要结局

The World Health Organization Disability Assessment Schedule II (WHODAS 2.0)

时间窗: Monthly from baseline to endpointat 24 months and at follow-up at 36 months.

Level of daily functioning and disability in the domains of cognition, mobility, self-care, getting along with other people and life activities.

次要结局

  • Cost effectiveness(Monthly from baseline to endpointat 24 months and at follow-up at 36 months.)
  • Five Self-harm behaviour groupings measure (5S-HM)(Weekly from baseline to endpointat 24 months and at follow-up at 36 months.)
  • The 5-level EQ-5D(Monthly from baseline to endpointat 24 months and at follow-up at 36 months.)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (1)

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