Aspects of Self-harm - Cognition, Imaging and Treatability

Study Overview
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Brief Summary
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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
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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: individuals with psychiatric disorders and persistent DSH individuals with psychiatric disorders who have ceased DSH individuals with psychiatric disorders who never had DSH 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.

Official Title
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Aspects of Self-harm - Cognition, Imaging and Treatability

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

Intervention / Treatment
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* Diagnostic Test: Emotional Stop Signal Task
* Diagnostic Test: Magnetic Resonance Imaging
* Other: World Health Organizations Disability Assessment Schedule (WHODAS 2.0)
* Diagnostic Test: Personality Inventory for DSM-5 (PID-5)
* Diagnostic Test: Stop Signal Task (CANTAB)
* Diagnostic Test: Intra-Extra Dimensional Set Shift (CANTAB)
* Diagnostic Test: Spatial Working Memory Test (CANTAB)
* Diagnostic Test: Multitasking Test (CANTAB)
* Diagnostic Test: Cambridge Gambling Task Test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Deliberate self-harm<br>Individuals with psychiatric disorders and persistent DSH | Diagnostic Test: Emotional Stop Signal Task<br>* Emotional Stop Signal Task (modified version from CANTAB). Outcome Measure is commission and omission errors - higher score (percentage) indicate worse performance.<br>Diagnostic Test: Magnetic Resonance Imaging<br>* Functional Magnetic Resonance Imaging (fMRI) Diffusion Tensor Imaging (DTI) Volumetry<br>Other: World Health Organizations Disability Assessment Schedule (WHODAS 2.0)<br>* Self-reported data on World Health Organizations Disability Assessment Schedule - 36 items self-administered (WHODAS 2.0). Assessing six domains of functional disability in daily life. Each item is rated on a Likert scale ranging from 0-4. Total range 0 - 144. High scores scores indicate more severe disability.<br>Diagnostic Test: Personality Inventory for DSM-5 (PID-5)<br>* Self-rated personality traits through Personality Inventory for DSM-5 (PID-5). Self-reported scores on domains of personality traits. Higher scores in one domain indicate more pronounced traits in this domain.<br>Diagnostic Test: Stop Signal Task (CANTAB)<br>* The estimate of time where an individual can successfully inhibit their responses 50% of the time.<br>Diagnostic Test: Intra-Extra Dimensional Set Shift (CANTAB)<br>* The number of trials for which the outcome was an incorrect response (subject pressed the incorrect button within the response window), calculated across all assessed trials. The total number of times that the subject chose a wrong stimulus - i.e. one incompatible with the current rule, adjustment for every stage that was not reached.<br>Diagnostic Test: Spatial Working Memory Test (CANTAB)<br>* The number of times the subject incorrectly revisits a box in which a token has previously been found. Calculated across all assessed four, six and eight token trials. The number of times a subject begins a new search pattem from the same box they started with previously. If they always begin a search from the same starting point, we infer that the subject is employing a planned strategy for finding the tokens. Therefore, a low score indicates high strategy use (1 = they always begin the search from the same box), a high score indicates that they are beginning their searches from many different boxes. Calculated across assessed trials with 6 tokens or more.<br>Diagnostic Test: Multitasking Test (CANTAB)<br>* The number of trials for which the outcome was an incorrect response. The median latency of response (from stimulus appearance to button press). Calculated across all correct, assessed trials. The difference between the median latency of response on the trials that were congruent versus the trials that were incongruent. A positive score indicates that the subject is faster on congruent trials and a negative score indicates that the subject is faster on incongruent trials. A higher incongruency cost indicates that the subjects take longer to process conflicting information. The difference between the median latency of response during assessed blocks in which both rules are used versus assessed blocks in which only a single rule is used. A positive score indicates that the subject responds more slowly during multitasking blocks and indicates a higher cost of managing multiple sources of information.<br>Diagnostic Test: Cambridge Gambling Task Test<br>* The proportion (0 - 1) of all trials where the subject chose the majority box color. Calculated over all assessed trials from both the ascending and descending conditions in which the number of boxes of each color differed. Risk adjustment is a measure of sensitivity to risk, based on the ability to modify choices in the light of information about the probability of different outcomes and to track the optimal outcome on eaeh trial. The measure is calculated from the average proportion of points that the subject ehose to bet with, taking into aeeount the number of colored boxes in the majority. Allows for the dissociation between risk taking and impulsivity by determining whether subjects simply just place a bet at the first opportunity. Calculated as CGT Risk Taking for all trials from the descending condition minus CGT Risk Taking for all trials from the ascending condition.<br>|
| Clinical cases who ceased self-harm<br>Individuals with psychiatric disorders who have ceased DSH | Diagnostic Test: Emotional Stop Signal Task<br>* Emotional Stop Signal Task (modified version from CANTAB). Outcome Measure is commission and omission errors - higher score (percentage) indicate worse performance.<br>Diagnostic Test: Magnetic Resonance Imaging<br>* Functional Magnetic Resonance Imaging (fMRI) Diffusion Tensor Imaging (DTI) Volumetry<br>Other: World Health Organizations Disability Assessment Schedule (WHODAS 2.0)<br>* Self-reported data on World Health Organizations Disability Assessment Schedule - 36 items self-administered (WHODAS 2.0). Assessing six domains of functional disability in daily life. Each item is rated on a Likert scale ranging from 0-4. Total range 0 - 144. High scores scores indicate more severe disability.<br>Diagnostic Test: Personality Inventory for DSM-5 (PID-5)<br>* Self-rated personality traits through Personality Inventory for DSM-5 (PID-5). Self-reported scores on domains of personality traits. Higher scores in one domain indicate more pronounced traits in this domain.<br>Diagnostic Test: Stop Signal Task (CANTAB)<br>* The estimate of time where an individual can successfully inhibit their responses 50% of the time.<br>Diagnostic Test: Intra-Extra Dimensional Set Shift (CANTAB)<br>* The number of trials for which the outcome was an incorrect response (subject pressed the incorrect button within the response window), calculated across all assessed trials. The total number of times that the subject chose a wrong stimulus - i.e. one incompatible with the current rule, adjustment for every stage that was not reached.<br>Diagnostic Test: Spatial Working Memory Test (CANTAB)<br>* The number of times the subject incorrectly revisits a box in which a token has previously been found. Calculated across all assessed four, six and eight token trials. The number of times a subject begins a new search pattem from the same box they started with previously. If they always begin a search from the same starting point, we infer that the subject is employing a planned strategy for finding the tokens. Therefore, a low score indicates high strategy use (1 = they always begin the search from the same box), a high score indicates that they are beginning their searches from many different boxes. Calculated across assessed trials with 6 tokens or more.<br>Diagnostic Test: Multitasking Test (CANTAB)<br>* The number of trials for which the outcome was an incorrect response. The median latency of response (from stimulus appearance to button press). Calculated across all correct, assessed trials. The difference between the median latency of response on the trials that were congruent versus the trials that were incongruent. A positive score indicates that the subject is faster on congruent trials and a negative score indicates that the subject is faster on incongruent trials. A higher incongruency cost indicates that the subjects take longer to process conflicting information. The difference between the median latency of response during assessed blocks in which both rules are used versus assessed blocks in which only a single rule is used. A positive score indicates that the subject responds more slowly during multitasking blocks and indicates a higher cost of managing multiple sources of information.<br>Diagnostic Test: Cambridge Gambling Task Test<br>* The proportion (0 - 1) of all trials where the subject chose the majority box color. Calculated over all assessed trials from both the ascending and descending conditions in which the number of boxes of each color differed. Risk adjustment is a measure of sensitivity to risk, based on the ability to modify choices in the light of information about the probability of different outcomes and to track the optimal outcome on eaeh trial. The measure is calculated from the average proportion of points that the subject ehose to bet with, taking into aeeount the number of colored boxes in the majority. Allows for the dissociation between risk taking and impulsivity by determining whether subjects simply just place a bet at the first opportunity. Calculated as CGT Risk Taking for all trials from the descending condition minus CGT Risk Taking for all trials from the ascending condition.<br>|
| Clinical cases with no self-harm<br>Individuals with psychiatric disorders who never had DSH | Diagnostic Test: Emotional Stop Signal Task<br>* Emotional Stop Signal Task (modified version from CANTAB). Outcome Measure is commission and omission errors - higher score (percentage) indicate worse performance.<br>Diagnostic Test: Magnetic Resonance Imaging<br>* Functional Magnetic Resonance Imaging (fMRI) Diffusion Tensor Imaging (DTI) Volumetry<br>Other: World Health Organizations Disability Assessment Schedule (WHODAS 2.0)<br>* Self-reported data on World Health Organizations Disability Assessment Schedule - 36 items self-administered (WHODAS 2.0). Assessing six domains of functional disability in daily life. Each item is rated on a Likert scale ranging from 0-4. Total range 0 - 144. High scores scores indicate more severe disability.<br>Diagnostic Test: Personality Inventory for DSM-5 (PID-5)<br>* Self-rated personality traits through Personality Inventory for DSM-5 (PID-5). Self-reported scores on domains of personality traits. Higher scores in one domain indicate more pronounced traits in this domain.<br>Diagnostic Test: Stop Signal Task (CANTAB)<br>* The estimate of time where an individual can successfully inhibit their responses 50% of the time.<br>Diagnostic Test: Intra-Extra Dimensional Set Shift (CANTAB)<br>* The number of trials for which the outcome was an incorrect response (subject pressed the incorrect button within the response window), calculated across all assessed trials. The total number of times that the subject chose a wrong stimulus - i.e. one incompatible with the current rule, adjustment for every stage that was not reached.<br>Diagnostic Test: Spatial Working Memory Test (CANTAB)<br>* The number of times the subject incorrectly revisits a box in which a token has previously been found. Calculated across all assessed four, six and eight token trials. The number of times a subject begins a new search pattem from the same box they started with previously. If they always begin a search from the same starting point, we infer that the subject is employing a planned strategy for finding the tokens. Therefore, a low score indicates high strategy use (1 = they always begin the search from the same box), a high score indicates that they are beginning their searches from many different boxes. Calculated across assessed trials with 6 tokens or more.<br>Diagnostic Test: Multitasking Test (CANTAB)<br>* The number of trials for which the outcome was an incorrect response. The median latency of response (from stimulus appearance to button press). Calculated across all correct, assessed trials. The difference between the median latency of response on the trials that were congruent versus the trials that were incongruent. A positive score indicates that the subject is faster on congruent trials and a negative score indicates that the subject is faster on incongruent trials. A higher incongruency cost indicates that the subjects take longer to process conflicting information. The difference between the median latency of response during assessed blocks in which both rules are used versus assessed blocks in which only a single rule is used. A positive score indicates that the subject responds more slowly during multitasking blocks and indicates a higher cost of managing multiple sources of information.<br>Diagnostic Test: Cambridge Gambling Task Test<br>* The proportion (0 - 1) of all trials where the subject chose the majority box color. Calculated over all assessed trials from both the ascending and descending conditions in which the number of boxes of each color differed. Risk adjustment is a measure of sensitivity to risk, based on the ability to modify choices in the light of information about the probability of different outcomes and to track the optimal outcome on eaeh trial. The measure is calculated from the average proportion of points that the subject ehose to bet with, taking into aeeount the number of colored boxes in the majority. Allows for the dissociation between risk taking and impulsivity by determining whether subjects simply just place a bet at the first opportunity. Calculated as CGT Risk Taking for all trials from the descending condition minus CGT Risk Taking for all trials from the ascending condition.<br>|
| Healthy controls<br>Healthy controls who never had DSH | Diagnostic Test: Emotional Stop Signal Task<br>* Emotional Stop Signal Task (modified version from CANTAB). Outcome Measure is commission and omission errors - higher score (percentage) indicate worse performance.<br>Diagnostic Test: Magnetic Resonance Imaging<br>* Functional Magnetic Resonance Imaging (fMRI) Diffusion Tensor Imaging (DTI) Volumetry<br>Other: World Health Organizations Disability Assessment Schedule (WHODAS 2.0)<br>* Self-reported data on World Health Organizations Disability Assessment Schedule - 36 items self-administered (WHODAS 2.0). Assessing six domains of functional disability in daily life. Each item is rated on a Likert scale ranging from 0-4. Total range 0 - 144. High scores scores indicate more severe disability.<br>Diagnostic Test: Personality Inventory for DSM-5 (PID-5)<br>* Self-rated personality traits through Personality Inventory for DSM-5 (PID-5). Self-reported scores on domains of personality traits. Higher scores in one domain indicate more pronounced traits in this domain.<br>Diagnostic Test: Stop Signal Task (CANTAB)<br>* The estimate of time where an individual can successfully inhibit their responses 50% of the time.<br>Diagnostic Test: Intra-Extra Dimensional Set Shift (CANTAB)<br>* The number of trials for which the outcome was an incorrect response (subject pressed the incorrect button within the response window), calculated across all assessed trials. The total number of times that the subject chose a wrong stimulus - i.e. one incompatible with the current rule, adjustment for every stage that was not reached.<br>Diagnostic Test: Spatial Working Memory Test (CANTAB)<br>* The number of times the subject incorrectly revisits a box in which a token has previously been found. Calculated across all assessed four, six and eight token trials. The number of times a subject begins a new search pattem from the same box they started with previously. If they always begin a search from the same starting point, we infer that the subject is employing a planned strategy for finding the tokens. Therefore, a low score indicates high strategy use (1 = they always begin the search from the same box), a high score indicates that they are beginning their searches from many different boxes. Calculated across assessed trials with 6 tokens or more.<br>Diagnostic Test: Multitasking Test (CANTAB)<br>* The number of trials for which the outcome was an incorrect response. The median latency of response (from stimulus appearance to button press). Calculated across all correct, assessed trials. The difference between the median latency of response on the trials that were congruent versus the trials that were incongruent. A positive score indicates that the subject is faster on congruent trials and a negative score indicates that the subject is faster on incongruent trials. A higher incongruency cost indicates that the subjects take longer to process conflicting information. The difference between the median latency of response during assessed blocks in which both rules are used versus assessed blocks in which only a single rule is used. A positive score indicates that the subject responds more slowly during multitasking blocks and indicates a higher cost of managing multiple sources of information.<br>Diagnostic Test: Cambridge Gambling Task Test<br>* The proportion (0 - 1) of all trials where the subject chose the majority box color. Calculated over all assessed trials from both the ascending and descending conditions in which the number of boxes of each color differed. Risk adjustment is a measure of sensitivity to risk, based on the ability to modify choices in the light of information about the probability of different outcomes and to track the optimal outcome on eaeh trial. The measure is calculated from the average proportion of points that the subject ehose to bet with, taking into aeeount the number of colored boxes in the majority. Allows for the dissociation between risk taking and impulsivity by determining whether subjects simply just place a bet at the first opportunity. Calculated as CGT Risk Taking for all trials from the descending condition minus CGT Risk Taking for all trials from the ascending condition.<br>|

What is the study measuring?
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Primary Outcome Measures

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