Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-27 @ 10:42 PM
Study NCT ID:
NCT06099561
Status:
RECRUITING
Last Update Posted:
2024-12-10
First Post:
2023-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intractable Self-harm-What Support is Effective?
Sponsor:
Region Skane
Organization:
Study Overview
Official Title:
Svårbehandlat självskadebeteende-Vilka Insatser är Effektiva?
Status:
RECRUITING
Status Verified Date:
2024-12
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:
False
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?: