Intractable Self-harm-What Support is Effective?

• Sponsor: Region Skane (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06099561
• Collaborator: Department of Psychology. Lund University. (Other), Department of Clinical Sciences, Malmö. Faculty of Medicine, Lund University. (Other)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 40
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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:

1. Is there, in individuals with intractable self-harm, a relevant improvement in frequency and severity of self-harm?

2. Is there, in individuals with intractable self-harm, a relevant improvement in voluntary hospital admissions?

3. Is there, in individuals with intractable self-harm, a relevant improvement in compulsary hospital admissions?

4. Is there, in individuals with intractable self-harm, a relevant improvement in the use of medication pro re nata?

5. Is there, in individuals with intractable self-harm, a relevant improvement in cost-effectiveness related to the provided interventions?

Condition or Disease	Intervention/Treatment	Phase
Self-harm	Behavioral: National specialized medical care unit for severe self-harm behaviour-Consultation model

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
• Anticipated Enrollment: 30 participants
• Observational Model: Case-Only
• Time Perspective: Other
• Official Title: Svårbehandlat självskadebeteende-Vilka Insatser är Effektiva?
• Actual Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2026
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
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.	Behavioral: National specialized medical care unit for severe self-harm behaviour-Consultation model; Extensive assessments. Consultation and training for existing treatment providers and caregivers. Network-meetings for providers and caregivers.

Outcome Measures

Primary Outcome Measures

1. The World Health Organization Disability Assessment Schedule II (WHODAS 2.0) [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 Outcome Measures

1. Five Self-harm behaviour groupings measure (5S-HM) [Weekly from baseline to endpointat 24 months and at follow-up at 36 months.]

   Indirect and direct self-harming behaviour

2. The 5-level EQ-5D [Monthly from baseline to endpointat 24 months and at follow-up at 36 months.]

   Quality of life scale

3. Cost effectiveness [Monthly from baseline to endpointat 24 months and at follow-up at 36 months.]

   Quantities and costs related to healthcare, municipal, social and rescue services.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Highly Specialized Unit for Self-Harm Behaviours, Skåne	Lund	Skåne	Sweden	22185

Sponsors and Collaborators

• Region Skane
• Department of Psychology. Lund University.
• Department of Clinical Sciences, Malmö. Faculty of Medicine, Lund University.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Region Skane
• ClinicalTrials.gov Identifier: NCT06099561
• Other Study ID Numbers: Dnr 2023-01650-01
• First Posted: Oct 25, 2023
• Last Update Posted: Oct 25, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Region Skane: Deliberate self-harm; Suicide
• Additional relevant MeSH terms: Self-Injurious Behavior

Study Results

No Results Posted as of Oct 25, 2023