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临床试验/NCT04905797
NCT04905797已完成不适用

Aspects of Self-harm - Cognition, Imaging and Treatability

Region Skane2 个研究点 分布在 1 个国家目标入组 316 人开始时间: 2021年4月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Region Skane
入组人数
316
试验地点
2
主要终点
Volumetry

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Volumetry

时间窗: Up to 1 hour

Volumes of local cerebral white matter

Executive functioning

时间窗: Up to 1 hour

Scores on cognitive tests measuring executive functioning

Level of function in daily life

时间窗: 30 days

Scores on WHODAS 2.0

Personality traits

时间窗: More than 1 year (stable)

Scores on Personality Inventory for DSM-5

Blood flow

时间窗: Up to 1 hour

Blood flow in prefrontal cortex during neurocognitive tests

次要结局

未报告次要终点

研究者

发起方
Region Skane
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sofie Westling

MD, associate professor

Region Skane

研究点 (2)

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