Clinical trial NCT04905797: Aspects of Self-harm - Cognition, Imaging and Treatability
Official title: Aspects of Self-harm - Cognition, Imaging and Treatability
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Self-Harm, Deliberate
Non-Suicidal Self Injury
Attempt Suicide
Personality Disorders
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2021-05-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical participants will be recruited though a cohort listed on an out-patient psychiatric clinic in Lund.

Healthy controls will be recruited through through fliers placed on public advertisement boards.

Brief summary: Deliberate self-harm (DSH) is a common symptom in psychiatric disorders. This study aim at increased understanding of parameters associated with DSH with the long term goal to potentially improve and possibly personalise its treatment.

In short, the study will characterise cognitive, psychiatric and demographic factors with focus on executive function and will compare results from individuals with DSH, individuals who have ceased DSH as well as psychiatric patients without DSH and individuals who never engaged in DSH. Adequate statistical tests will be used to compare groups.

Participants will be interviewed by a trained physician for basic medical history, history of self-harm and treatment for that, demographic data and diagnostic evaluation. Thereafter the participants will undergo standardised neuropsychological testing focusing on emotional response inhibition, decision making and risk taking, attention set shifting, working memory, inhibition and planning. Some participants will redo parts of this testing during fMRI, as well as undergo DTI and volumetry.

Detailed description: Deliberate self-harm (DSH) is a common symptom in psychiatric disorders. Today, there is not sufficient knowledge as to why an individual continues to suffer from DSH, DSH is reduced or even ceased - regardless given treatment or not. The overall aim of this project is to characterise cognitive, psychiatric and demographic factors as well as perform brain imaging in individuals currently suffering from DSH, individuals with a prior history of DSH, individuals with psychiatric disease but no DSH and healthy individuals. The intention is to gain more knowledge on factors associated with DSH and thereby potentially improve and possibly personalize treatment.

The following hypotheses will be tested:

Individuals currently suffering from DSH have lower scores on executive function than individuals with a prior history of DSH, individuals with psychiatric disease but no DSH and healthy individuals.

Individuals currently suffering from DSH have lower level daily life functioning and more severe psychiatric symptoms than individuals with a prior history of DSH, individuals with psychiatric disease but no DSH and healthy individuals.

Individuals currently suffering from DSH have higher scores of negative affectivity, lower scores of antagonism and lower scores of disinhibition measured with Personality Inventory for DSM-5 than individuals with a prior history of DSH, individuals with psychiatric disease but no DSH and healthy individuals.

Individuals currently suffering from DSH have, when executing the neurocognitive tests in hypothesis 1, a significant lower blood flow in the prefrontal network, than individuals with a prior history of DSH, individuals with psychiatric disease but no DSH and healthy individuals.

Individuals currently suffering from DSH have a decrease in local cerebral white matter compared to individuals with a prior history of DSH, individuals with psychiatric disease but no DSH and healthy individuals.

Material:

The aim is to recruit 300 participants in total, 75 participants to each group:

1. individuals with psychiatric disorders and persistent DSH
2. individuals with psychiatric disorders who have ceased DSH
3. individuals with psychiatric disorders who never had DSH
4. healthy controls who never had DSH

Participants will be interviewed by a trained physician for basic medical history, history of self-harm and treatment for that, demographic data and diagnostic evaluation. Thereafter the participants will undergo standardised neuropsychological testing focusing on emotional response inhibition, decision making and risk taking, attention set shifting, working memory, inhibition and planning. Some participants will redo parts of this testing during fMRI, as well as undergo DTI and volumetry.

Eligibility criteria: Inclusion criteria for persistent DSH group:

* Adults 18-65 years.
* Ability to leave informed consent.
* Understands and uses the Swedish language without significant difficulties.
* Psychiatric disorder and ongoing treatment at an adult psychiatric clinic.
* DSH at least five times during the last three months, and DSH at least ten times during at least one year.

Exclusion criteria for persistent DSH group:

* No history of DSH, and/or DSH fewer than five times during the last three months and fewer than ten times during at least one year
* Diagnosis of Intellectual disability
* Diagnosis of chronic psychotic disorder
* Hearing disability, visual impairment or motor disorder that rules out the ability to complete neurocognitive tasks

Inclusion criteria for those who have ceased DSH group:

* Adults 18-65 years.
* Ability to leave informed consent.
* Understands and uses the Swedish language without significant difficulties.
* Psychiatric disorder and ongoing treatment at an adult psychiatric clinic.
* No DSH during the last three months, but DSH at least ten times during at least one year.

Exclusion criteria for those who have ceased DSH group:

* Any DSH during the last three months, and/or fewer than ten times during the at least one year
* Diagnosis of Intellectual disability
* Diagnosis of chronic psychotic disorder
* Hearing disability, visual impairment or motor disorder that rules out the ability to complete neurocognitive tasks

Inclusion criteria for psychiatric disorder with no history of DSH group:

* Adults 18-65 years.
* Ability to leave informed consent.
* Understands and uses the Swedish language without significant difficulties.
* Psychiatric disorder and ongoing treatment at an adult psychiatric clinic.

Exclusion criteria for psychiatric disorder with no history of DSH group:

* Any DSH during the last three months, and more than two times during lifetime
* Diagnosis of Intellectual disability
* Diagnosis of chronic psychotic disorder
* Hearing disability, visual impairment or motor disorder that rules out the ability to complete neurocognitive tasks

Inclusion criteria for healthy control group:

* Adults 18-65 years.
* Ability to leave informed consent.
* Understands and uses the Swedish language without significant difficulties.

Exclusion criteria for healthy control group:

* Diagnosed with any psychiatric disorder
* Any DSH during the last three months, and more than two times during lifetime
* Hearing disability, visual impairment or motor disorder that rules out the ability to complete neurocognitive tasks

Primary outcomes:
measure: Executive functioning
timeFrame: Up to 1 hour
measure: Level of function in daily life
timeFrame: 30 days
measure: Personality traits
timeFrame: More than 1 year (stable)
measure: Blood flow
timeFrame: Up to 1 hour
measure: Volumetry
timeFrame: Up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Psykiatri och habilitering, Region Skåne
state: Skåne
Study officials:
affiliation: Region Skåne
name: Sofie Westling, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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