Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06099561

Intractable Self-harm-What Support is Effective?

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?

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Highly Specialized Unit for Self-Harm Behaviours, Skåne

Lund, Skåne County, 22185, Sweden

Location status: Recruiting

Location contact

Magnus Nilsson, PhD

CONTACT

[email protected]

046-174925

Magnus Nilsson, PhD

PRINCIPAL_INVESTIGATOR

Sofie Westling, MD/PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

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

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

    Indirect and direct self-harming behaviour

  2. The 5-level EQ-5D

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

    Quality of life scale

  3. Cost effectiveness

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Magnus Nilsson, PhD

CONTACT

[email protected]

046-174925

Sofie Westling, MD/PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Department of Clinical Sciences, Malmö. Faculty of Medicine, Lund University.
  • Department of Psychology. Lund University.

Registry information

Official study title

Svårbehandlat självskadebeteende-Vilka Insatser är Effektiva?

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 25, 2023
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.