Intractable Self-harm-What Support is Effective?

Self-harm Clinical Trial

Official title:

Svårbehandlat självskadebeteende-Vilka Insatser är Effektiva?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06099561
• Other study ID #: Dnr 2023-01650-01
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: Region Skane
• Contact: Magnus Nilsson, PhD
• Phone: 046-174925
• Email: magnus.per.nilsson[@]skane.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Self-harm
• Self-Injurious Behavior

Intervention

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.

Locations

Country	Name	City	State
Sweden	National Highly Specialized Unit for Self-Harm Behaviours, Skåne	Lund	Skåne

Sponsors (3)

Lead Sponsor	Collaborator
Region Skane	Department of Clinical Sciences, Malmö. Faculty of Medicine, Lund University., Department of Psychology. Lund University.

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The World Health Organization Disability Assessment Schedule II (WHODAS 2.0)	Level of daily functioning and disability in the domains of cognition, mobility, self-care, getting along with other people and life activities.	Monthly from baseline to endpointat 24 months and at follow-up at 36 months.
Secondary	Five Self-harm behaviour groupings measure (5S-HM)	Indirect and direct self-harming behaviour	Weekly from baseline to endpointat 24 months and at follow-up at 36 months.
Secondary	The 5-level EQ-5D	Quality of life scale	Monthly from baseline to endpointat 24 months and at follow-up at 36 months.
Secondary	Cost effectiveness	Quantities and costs related to healthcare, municipal, social and rescue services.	Monthly from baseline to endpointat 24 months and at follow-up at 36 months.