Intractable Self-harm-What Support is Effective?

Svårbehandlat självskadebeteende-Vilka Insatser är Effektiva?

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?

Study Overview

• Status: Recruiting
• Conditions: Self-harm
• Intervention / Treatment: Behavioral: National specialized medical care unit for severe self-harm behaviour-Consultation model

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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Magnus Nilsson, PhD; Phone Number: 046-174925; Email: magnus.per.nilsson@skane.se
• Study Contact Backup: Name: Sofie Westling, MD/PhD; Email: sofie.westling@skane.se

Study Locations

• Sweden
  • Skåne County
    • Lund, Skåne County, Sweden, 22185
      • Recruiting
      • National Highly Specialized Unit for Self-Harm Behaviours, Skåne
      • Principal Investigator: Magnus Nilsson, PhD
      • Contact: Magnus Nilsson, PhD; Phone Number: 046-174925; Email: magnus.per.nilsson@skane.se
      • Contact: Sofie Westling, MD/PhD; Email: sofie.westling@skane.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Extensive assessments. Consultation and training for existing treatment providers and caregivers. Network-meetings for providers and caregivers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
The 5-level EQ-5D	Quality of life scale	Monthly from baseline to endpointat 24 months and at follow-up at 36 months.
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.

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Department of Psychology. Lund University.; Department of Clinical Sciences, Malmö. Faculty of Medicine, Lund University.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Suicide; Deliberate self-harm
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior
• Other Study ID Numbers: Dnr 2023-01650-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Possible ot applicable due to Swedish data protection legislation.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No