Intractable Self-harm-What Support is Effective?

Официальное название

Svårbehandlat självskadebeteende-Vilka Insatser är Effektiva?

Обзор

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?

Подробное описание

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.

Вмешательства

• Поведенческое National specialized medical care unit for severe self-harm behaviour-Consultation model
  Extensive assessments. Consultation and training for existing treatment providers and caregivers. Network-meetings for providers and caregivers.

Первичные конечные точки

• The World Health Organization Disability Assessment Schedule II (WHODAS 2.0) [Срок оценки: Monthly from baseline to endpointat 24 months and at follow-up at 36 months.]

Вторичные конечные точки (3)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Швеция · 1 центр

• National Highly Specialized Unit for Self-Harm Behaviours, Skåne — Lund

Идентификаторы

NCT: NCT06099561 · Dnr 2023-01650-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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