Intractable Self-harm-What Support is Effective?

NCT06099561 | Recruiting

• 1 other identifier: Dnr 2023-01650-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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?

Conditions

Self-harm

Keywords

Deliberate self-harm; Suicide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Five Self-harm behaviour groupings measure (5S-HM)

  Weekly from baseline to endpointat 24 months and at follow-up at 36 months.

• The 5-level EQ-5D

  Monthly from baseline to endpointat 24 months and at follow-up at 36 months.

• Cost effectiveness

  Monthly from baseline to endpointat 24 months and at follow-up at 36 months.

Study Arms (1)

Study group

Individuals with current severe, imminent and lethal self-harm with a history of at least two interventions without sufficient reduction of self-harm or suffering.

Behavioral: National specialized medical care unit for severe self-harm behaviour-Consultation model

Interventions

National specialized medical care unit for severe self-harm behaviour-Consultation model BEHAVIORAL

Extensive assessments. Consultation and training for existing treatment providers and caregivers. Network-meetings for providers and caregivers.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A group of individuals with severe self-harm, commonly with comorbid psychiatric diagnoses and cognitive challanges.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Region Skane: lead
• Department of Psychology. Lund University.: collaborator
• Department of Clinical Sciences, Malmö. Faculty of Medicine, Lund University.: collaborator

Study Sites (1)

National Highly Specialized Unit for Self-Harm Behaviours, Skåne

Lund, Skåne County, 22185, Sweden

RECRUITING

MeSH Terms

Conditions

Self-Injurious Behavior; Suicide

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Magnus Nilsson, PhD

CONTACT

046-174925; magnus.per.nilsson@skane.se

Sofie Westling, MD/PhD

CONTACT

sofie.westling@skane.se

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 25, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

SE (1)