Self-harmNCT06099561
Intractable Self-harm-What Support is Effective?
An observational study of Self-harm, run by Region Skane at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Self-harm
- What is being tested?
- National specialized medical care unit for severe self-harm behaviour-Consultation model
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A group of individuals with severe self-harm, commonly with comorbid psychiatric diagnoses and cognitive challanges.
Who may be able to join
- 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
Who cannot join
- Need for translation services to complete measures or interviews
- Not able to complete measures or interviews
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sofie Westling, MD/PhD contact
Sweden1 site, 1 recruiting
- Recruiting
National Highly Specialized Unit for Self-Harm Behaviours, Skåne
Lund, Skåne County, 22185
Magnus Nilsson, PhD, 046-174925, magnus.per.nilsson@skane.se
Sofie Westling, MD/PhD, sofie.westling@skane.se
About this study
Official title: Svårbehandlat självskadebeteende-Vilka Insatser är Effektiva?
The aim of this project is to evaluate a novel treatment program for individuals with intractable and lethal self-harm.
The main questions are:
Read more
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:
- Is there, in individuals with intractable self-harm, a relevant improvement in frequency and severity of self-harm?
- Is there, in individuals with intractable self-harm, a relevant improvement in voluntary hospital admissions?
- Is there, in individuals with intractable self-harm, a relevant improvement in compulsary hospital admissions?
- Is there, in individuals with intractable self-harm, a relevant improvement in the use of medication pro re nata?
- Is there, in individuals with intractable self-harm, a relevant improvement in cost-effectiveness related to the provided interventions?
Read the 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.
- Conditions
- Self-harm
- Being tested
- National specialized medical care unit for severe self-harm behaviour-Consultation model
- Keywords
- Deliberate self-harm, Suicide
- Medical subject headings
- Self-Injurious Behavior, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
National specialized medical care unit for severe self-harm behaviour-Consultation modelBehavioural
Extensive assessments. Consultation and training for existing treatment providers and caregivers. Network-meetings for providers and caregivers.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: National specialized medical care unit for severe self-harm behaviour-Consultation model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Monthly from baseline to endpointat 24 months and at follow-up at 36 months.
Secondary outcomes (3)
Five Self-harm behaviour groupings measure (5S-HM)
Indirect and direct self-harming behaviour
Measured: Weekly from baseline to endpointat 24 months and at follow-up at 36 months.
The 5-level EQ-5D
Quality of life scale
Measured: Monthly from baseline to endpointat 24 months and at follow-up at 36 months.
Cost effectiveness
Quantities and costs related to healthcare, municipal, social and rescue services.
Measured: Monthly from baseline to endpointat 24 months and at follow-up at 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-harmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Psychology. Lund University., Department of Clinical Sciences, Malmö. Faculty of Medicine, Lund University.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099561
- Sponsor's protocol ID
- Dnr 2023-01650-01
- Status last verified
- Apr 2026
- First submitted
- 19 Oct 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Possible ot applicable due to Swedish data protection legislation.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Svårbehandlat självskadebeteende-Vilka Insatser är Effektiva?
- ClinicalTrials.gov ID
- NCT06099561
- Acronym / sponsor ID
- Dnr 2023-01650-01
- Conditions
- Self-harm
- Keywords
- Deliberate self-harm, Suicide
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Department of Psychology. Lund University., Department of Clinical Sciences, Malmö. Faculty of Medicine, Lund University.
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is there, in individuals with intractable self-harm, a relevant improvement in frequency and severity of self-harm?
- Is there, in individuals with intractable self-harm, a relevant improvement in voluntary hospital admissions?
- Is there, in individuals with intractable self-harm, a relevant improvement in compulsary hospital admissions?
- Is there, in individuals with intractable self-harm, a relevant improvement in the use of medication pro re nata?
- 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
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Behavioral: National specialized medical care unit for severe self-harm behaviour-Consultation modelIndividuals with current severe, imminent and lethal self-harm with a history of at least two interventions without sufficient reduction of self-harm or suffering. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A group of individuals with severe self-harm, commonly with comorbid psychiatric diagnoses and cognitive challanges.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Need for translation services to complete measures or interviews
- Not able to complete measures or interviews
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| National specialized medical care unit for severe self-harm behaviour-Consultation modelExtensive assessments. Consultation and training for existing treatment providers and caregivers. Network-meetings for providers and caregivers. | Behavioural | Study group |
Primary outcome
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.
3 secondary outcomes
Five Self-harm behaviour groupings measure (5S-HM)
Time frame: Weekly from baseline to endpointat 24 months and at follow-up at 36 months.
The 5-level EQ-5D
Time frame: Monthly from baseline to endpointat 24 months and at follow-up at 36 months.
Cost effectiveness
Time frame: Monthly from baseline to endpointat 24 months and at follow-up at 36 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided. Possible ot applicable due to Swedish data protection legislation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sofie Westling, MD/PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Self-harm, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magnus Nilsson, PhD (046-174925, magnus.per.nilsson@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.