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Intractable Self-harm-What Support is Effective?

Svårbehandlat självskadebeteende-Vilka Insatser är Effektiva?

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06099561
Enrollment
30
Registered
2023-10-25
Start date
2023-09-01
Completion date
2026-12-31
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Self-harm

Keywords

Deliberate self-harm, Suicide

Brief summary

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

BEHAVIORALNational 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.

Sponsors

Region Skane
Lead SponsorOTHER
Department of Psychology. Lund University.
CollaboratorUNKNOWN
Department of Clinical Sciences, Malmö. Faculty of Medicine, Lund University.
CollaboratorUNKNOWN

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Five Self-harm behaviour groupings measure (5S-HM)Weekly from baseline to endpointat 24 months and at follow-up at 36 months.Indirect and direct self-harming behaviour
The 5-level EQ-5DMonthly from baseline to endpointat 24 months and at follow-up at 36 months.Quality of life scale
Cost effectivenessMonthly from baseline to endpointat 24 months and at follow-up at 36 months.Quantities and costs related to healthcare, municipal, social and rescue services.

Countries

Sweden

Contacts

CONTACTMagnus Nilsson, PhD
magnus.per.nilsson@skane.se046-174925
CONTACTSofie Westling, MD/PhD
sofie.westling@skane.se

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026