Aspects of Self-harm - Cognition, Imaging and Treatability

Recruiting

• Conditions: Non-Suicidal Self Injury; Personality Disorders; Self-Harm, Deliberate; Attempt Suicide

• Registration Number: NCT04905797
• Lead Sponsor: Region Skane

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.

Study Timeline

• Study First Submitted: 2021-04-29
• Study Start: 2021-04-30
• Study First Submitted QC: 2021-05-23
• Study First Posted: 2021-05-28
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Executive functioning	Up to 1 hour	Scores on cognitive tests measuring executive functioning
Volumetry	Up to 1 hour	Volumes of local cerebral white matter
Level of function in daily life	30 days	Scores on WHODAS 2.0
Personality traits	More than 1 year (stable)	Scores on Personality Inventory for DSM-5
Blood flow	Up to 1 hour	Blood flow in prefrontal cortex during neurocognitive tests

Trial Locations

Locations (1)

Psykiatri och habilitering, Region Skåne; 🇸🇪 Lund, Skåne, Sweden