Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06099561
Status:
RECRUITING
Last Update Posted:
2023-10-25
First Post:
2023-10-19
Brief Title:
Intractable Self-harm-What Support is Effective
Sponsor:
Region Skane
Organization:
Region Skane
Study Overview
Official Title:
Svårbehandlat självskadebeteende-Vilka Insatser är Effektiva
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None