Intractable Self-harm-What Support is Effective?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: National specialized medical care unit for severe self-harm behaviour-Consultation model.
- Who it may be relevant to
- Registry conditions: Self-harm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Svårbehandlat självskadebeteende-Vilka Insatser är Effektiva?
Overview
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?
Detailed description
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.
Interventions
- Behavioral 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.
Primary outcome measures
- The World Health Organization Disability Assessment Schedule II (WHODAS 2.0) [Time frame: Monthly from baseline to endpointat 24 months and at follow-up at 36 months.]
Secondary outcome measures (3)
- Five Self-harm behaviour groupings measure (5S-HM) [Time frame: Weekly from baseline to endpointat 24 months and at follow-up at 36 months.]
- The 5-level EQ-5D [Time frame: Monthly from baseline to endpointat 24 months and at follow-up at 36 months.]
- Cost effectiveness [Time frame: Monthly from baseline to endpointat 24 months and at follow-up at 36 months.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Need for translation services to complete measures or interviews
- Not able to complete measures or interviews
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Sweden · 1 center
- National Highly Specialized Unit for Self-Harm Behaviours, Skåne — Lund
Identifiers
NCT: NCT06099561 · Dnr 2023-01650-01