Intractable Self-harm-What Support is Effective?
ConditionSelf-harm
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegion Skane
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Need for translation services to complete measures or interviews
Not able to complete measures or interviews
Trial population
A group of individuals with severe self-harm, commonly with comorbid psychiatric diagnoses and cognitive challanges.
Trial design
Design model
Case-only
Time perspective
Other
Treatments tested in this trial
National specialized medical care unit for severe self-harm behaviour-Consultation model
BehavioralExtensive assessments. Consultation and training for existing treatment providers and caregivers. Network-meetings for providers and caregivers.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Study group1 intervention
Trial outcomes
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.
Time frame
Monthly from baseline to endpointat 24 months and at follow-up at 36 months.Secondary outcomes
1
Five Self-harm behaviour groupings measure (5S-HM)
Indirect and direct self-harming behaviour
Time frame
Weekly from baseline to endpointat 24 months and at follow-up at 36 months.2
The 5-level EQ-5D
Quality of life scale
Time frame
Monthly from baseline to endpointat 24 months and at follow-up at 36 months.3
Cost effectiveness
Quantities and costs related to healthcare, municipal, social and rescue services.
Time frame
Monthly from baseline to endpointat 24 months and at follow-up at 36 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Region Skane
Lead sponsor
Department of Psychology. Lund University.
Collaborator
Department of Clinical Sciences, Malmö. Faculty of Medicine, Lund University.
Collaborator
Source ClinicalTrials.gov