Clinical trial NCT06099561: Intractable Self-harm-What Support is Effective?
Official title: Svårbehandlat självskadebeteende-Vilka Insatser är Effektiva?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Self-harm
Keywords: Deliberate self-harm
Suicide
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Department of Psychology. Lund University.
name: Department of Clinical Sciences, Malmö. Faculty of Medicine, Lund University.
First posted: 2023-10-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A group of individuals with severe self-harm, commonly with comorbid psychiatric diagnoses and cognitive challanges.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The World Health Organization Disability Assessment Schedule II (WHODAS 2.0)
timeFrame: Monthly from baseline to endpointat 24 months and at follow-up at 36 months.
Secondary outcomes:
measure: Five Self-harm behaviour groupings measure (5S-HM)
timeFrame: Weekly from baseline to endpointat 24 months and at follow-up at 36 months.
measure: The 5-level EQ-5D
timeFrame: Monthly from baseline to endpointat 24 months and at follow-up at 36 months.
measure: Cost effectiveness
timeFrame: Monthly from baseline to endpointat 24 months and at follow-up at 36 months.
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: National Highly Specialized Unit for Self-Harm Behaviours, Skåne
state: Skåne
Study officials:
References: