Svårbehandlat självskadebeteende-Vilka Insatser är Effektiva?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Region Skane
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- The World Health Organization Disability Assessment Schedule II (WHODAS 2.0)
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: National specialized medical care unit for severe self-harm behaviour-Consultation model (Behavioral)
Outcomes
Primary Outcomes
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
- Cost effectiveness(Monthly from baseline to endpointat 24 months and at follow-up at 36 months.)
- 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.)