Intractable Self-harm-What Support is Effective?

Recruiting

• Conditions: Self-harm

• Registration Number: NCT06099561
• Lead Sponsor: Region Skane

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.

Study Timeline

• Study Start: 2023-09-01
• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-19
• Study First Posted: 2023-10-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Cost effectiveness	Monthly from baseline to endpointat 24 months and at follow-up at 36 months.	Quantities and costs related to healthcare, municipal, social and rescue services.
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-5D	Monthly from baseline to endpointat 24 months and at follow-up at 36 months.	Quality of life scale

Trial Locations

Locations (1)

National Highly Specialized Unit for Self-Harm Behaviours, Skåne; 🇸🇪 Lund, Skåne, Sweden