Self-Harm, DeliberateNCT04905797
Aspects of Self-harm - Cognition, Imaging and Treatability
An observational study of Self-Harm, Deliberate and Non-Suicidal Self Injury, run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Self-Harm, Deliberate, Non-Suicidal Self Injury, Attempt Suicide
- What is being tested?
- Emotional Stop Signal Task, Magnetic Resonance Imaging and World Health Organizations Disability Assessment Schedule (WHODAS 2.0)
- How many people
- 316 participants
- Where
- 1 siteSweden
- Study dates
- 30 Apr 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
- Adults 18-65 years.
Show all 13Show fewer
- 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.
- Adults 18-65 years.
- Ability to leave informed consent.
- Understands and uses the Swedish language without significant difficulties.
Who cannot join
- 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
- Any DSH during the last three months, and/or fewer than ten times during the at least one year
- Diagnosis of Intellectual disability
Show all 21Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Psykiatri och habilitering, Region Skåne
Lund, Skåne County, 22185
About this study
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.
Read the 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:
- 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.
- Being tested
- Emotional Stop Signal Task, Magnetic Resonance Imaging, World Health Organizations Disability Assessment Schedule (WHODAS 2.0), Personality Inventory for DSM-5 (PID-5), Stop Signal Task (CANTAB)
- Medical subject headings
- Self-Injurious Behavior, Suicide, Attempted, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Stop Signal TaskDiagnostic test
Emotional Stop Signal Task (modified version from CANTAB). Outcome Measure is commission and omission errors - higher score (percentage) indicate worse performance.
Magnetic Resonance ImagingDiagnostic test
Functional Magnetic Resonance Imaging (fMRI) Diffusion Tensor Imaging (DTI) Volumetry
World Health Organizations Disability Assessment Schedule (WHODAS 2.0)Other
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.
Personality Inventory for DSM-5 (PID-5)Diagnostic test
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.
Stop Signal Task (CANTAB)Diagnostic test
The estimate of time where an individual can successfully inhibit their responses 50% of the time.
Intra-Extra Dimensional Set Shift (CANTAB)Diagnostic test
- 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.
Spatial Working Memory Test (CANTAB)Diagnostic test
- 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.
Multitasking Test (CANTAB)Diagnostic test
- 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.
Cambridge Gambling Task TestDiagnostic test
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Deliberate self-harm | Individuals with psychiatric disorders and persistent DSH Receives: 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 | |
| Clinical cases who ceased self-harm | Individuals with psychiatric disorders who have ceased DSH Receives: 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 | |
| Clinical cases with no self-harm | Individuals with psychiatric disorders who never had DSH Receives: 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 | |
| Healthy controls | Healthy controls who never had DSH Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive functioning
Scores on cognitive tests measuring executive functioning
Measured: Up to 1 hour
Level of function in daily life
Scores on WHODAS 2.0
Measured: 30 days
Personality traits
Scores on Personality Inventory for DSM-5
Measured: More than 1 year (stable)
Blood flow
Blood flow in prefrontal cortex during neurocognitive tests
Measured: Up to 1 hour
Volumetry
Volumes of local cerebral white matter
Measured: Up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start30 Apr 2021
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Self-Harm, DeliberateStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Principal investigator, Sofie Westling, Region Skane
- Investigators
- Sofie Westling, MD PhD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905797
- Sponsor's protocol ID
- 2020-02732
- Status last verified
- May 2026
- First submitted
- 29 Apr 2021
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data not protected by Swedish law of patient secrecy can be shared after analyses has been completed and man scripts accepted for publication
Publications
Allen KJ, Hooley JM. Inhibitory control in people who self-injure: evidence for impairment and enhancement. Psychiatry Res. 2015 Feb 28;225(3):631-7. doi: 10.1016/j.psychres.2014.11.033. Epub 2014 Dec 2.
PubMed 25510907Allen KJ, Hooley JM. Negative mood and interference control in nonsuicidal self-injury. Compr Psychiatry. 2017 Feb;73:35-42. doi: 10.1016/j.comppsych.2016.10.011. Epub 2016 Nov 4.
PubMed 27888700Allen KJD, Hooley JM. Negative Emotional Action Termination (NEAT): Support for a Cognitive Mechanism Underlying Negative Urgency in Nonsuicidal Self-Injury. Behav Ther. 2019 Sep;50(5):924-937. doi: 10.1016/j.beth.2019.02.001. Epub 2019 Feb 14.
PubMed 31422848McHugh CM, Chun Lee RS, Hermens DF, Corderoy A, Large M, Hickie IB. Impulsivity in the self-harm and suicidal behavior of young people: A systematic review and meta-analysis. J Psychiatr Res. 2019 Sep;116:51-60. doi: 10.1016/j.jpsychires.2019.05.012. Epub 2019 May 17.
PubMed 31195164Ackerman JP, McBee-Strayer SM, Mendoza K, Stevens J, Sheftall AH, Campo JV, Bridge JA. Risk-sensitive decision-making deficit in adolescent suicide attempters. J Child Adolesc Psychopharmacol. 2015 Mar;25(2):109-13. doi: 10.1089/cap.2014.0041. Epub 2014 Sep 29.
PubMed 25265242Oldershaw A, Grima E, Jollant F, Richards C, Simic M, Taylor L, Schmidt U. Decision making and problem solving in adolescents who deliberately self-harm. Psychol Med. 2009 Jan;39(1):95-104. doi: 10.1017/S0033291708003693. Epub 2008 Jun 23.
PubMed 18570698Chamberlain SR, Odlaug BL, Schreiber LR, Grant JE. Clinical and neurocognitive markers of suicidality in young adults. J Psychiatr Res. 2013 May;47(5):586-91. doi: 10.1016/j.jpsychires.2012.12.016. Epub 2013 Jan 26.
PubMed 23357208Fikke LT, Melinder A, Landro NI. Executive functions are impaired in adolescents engaging in non-suicidal self-injury. Psychol Med. 2011 Mar;41(3):601-10. doi: 10.1017/S0033291710001030. Epub 2010 May 19.
PubMed 20482935Gvirts HZ, Braw Y, Harari H, Lozin M, Bloch Y, Fefer K, Levkovitz Y. Executive dysfunction in bipolar disorder and borderline personality disorder. Eur Psychiatry. 2015 Nov;30(8):959-64. doi: 10.1016/j.eurpsy.2014.12.009. Epub 2015 Oct 21.
PubMed 26647872Thompson C, Ong ELC. The Association Between Suicidal Behavior, Attentional Control, and Frontal Asymmetry. Front Psychiatry. 2018 Mar 14;9:79. doi: 10.3389/fpsyt.2018.00079. eCollection 2018.
PubMed 29593586Thylander C, Nilsson M, van Westen D, Bjorkstrand J, Westling S. Elevated Negative Affectivity and Psychoticism in individuals with active Nonsuicidal Self-Injury (NSSI) compared with individuals with previous or no NSSI. Borderline Personal Disord Emot Dysregul. 2026 Sep 22;13(1):28. doi: 10.1186/s40479-026-00373-z.
PubMed 42773477
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspects of Self-harm - Cognition, Imaging and Treatability
- ClinicalTrials.gov ID
- NCT04905797
- Acronym / sponsor ID
- 2020-02732
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 28 May 2021 (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.
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:
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Deliberate self-harm | – | 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 TestIndividuals with psychiatric disorders and persistent DSH |
| Clinical cases who ceased self-harm | – | 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 TestIndividuals with psychiatric disorders who have ceased DSH |
| Clinical cases with no self-harm | – | 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 TestIndividuals with psychiatric disorders who never had DSH |
| Healthy controls | – | 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 TestHealthy controls who never had DSH |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
- Any DSH during the last three months, and/or fewer than ten times during the at least one year
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 |
|---|---|---|
| Emotional Stop Signal TaskEmotional Stop Signal Task (modified version from CANTAB). Outcome Measure is commission and omission errors - higher score (percentage) indicate worse performance. | Diagnostic test | Clinical cases who ceased self-harm, Clinical cases with no self-harm, Deliberate self-harm, Healthy controls |
| Magnetic Resonance ImagingFunctional Magnetic Resonance Imaging (fMRI) Diffusion Tensor Imaging (DTI) Volumetry | Diagnostic test | Clinical cases who ceased self-harm, Clinical cases with no self-harm, Deliberate self-harm, Healthy controls |
| World Health Organizations Disability Assessment Schedule (WHODAS 2.0)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. | Other | Clinical cases who ceased self-harm, Clinical cases with no self-harm, Deliberate self-harm, Healthy controls |
| Personality Inventory for DSM-5 (PID-5)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. | Diagnostic test | Clinical cases who ceased self-harm, Clinical cases with no self-harm, Deliberate self-harm, Healthy controls |
| Stop Signal Task (CANTAB)The estimate of time where an individual can successfully inhibit their responses 50% of the time. | Diagnostic test | Clinical cases who ceased self-harm, Clinical cases with no self-harm, Deliberate self-harm, Healthy controls |
| Intra-Extra Dimensional Set Shift (CANTAB)1. 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. 2. 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. | Diagnostic test | Clinical cases who ceased self-harm, Clinical cases with no self-harm, Deliberate self-harm, Healthy controls |
| Spatial Working Memory Test (CANTAB)1. 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. 2. 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. | Diagnostic test | Clinical cases who ceased self-harm, Clinical cases with no self-harm, Deliberate self-harm, Healthy controls |
| Multitasking Test (CANTAB)1. The number of trials for which the outcome was an incorrect response. 2. The median latency of response (from stimulus appearance to button press). Calculated across all correct, assessed trials. 3. 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. 4. 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. | Diagnostic test | Clinical cases who ceased self-harm, Clinical cases with no self-harm, Deliberate self-harm, Healthy controls |
| Cambridge Gambling Task Test1. 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. 2. 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. 3. 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. | Diagnostic test | Clinical cases who ceased self-harm, Clinical cases with no self-harm, Deliberate self-harm, Healthy controls |
Primary outcome
Executive functioning
Time frame: Up to 1 hour
Scores on cognitive tests measuring executive functioning
Level of function in daily life
Time frame: 30 days
Scores on WHODAS 2.0
Personality traits
Time frame: More than 1 year (stable)
Scores on Personality Inventory for DSM-5
Blood flow
Time frame: Up to 1 hour
Blood flow in prefrontal cortex during neurocognitive tests
Volumetry
Time frame: Up to 1 hour
Volumes of local cerebral white matter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 25510907Allen KJ, Hooley JM. Inhibitory control in people who self-injure: evidence for impairment and enhancement. Psychiatry Res. 2015 Feb 28;225(3):631-7. doi: 10.1016/j.psychres.2014.11.033. Epub 2014 Dec 2.
- Background: PubMed 27888700Allen KJ, Hooley JM. Negative mood and interference control in nonsuicidal self-injury. Compr Psychiatry. 2017 Feb;73:35-42. doi: 10.1016/j.comppsych.2016.10.011. Epub 2016 Nov 4.
- Background: PubMed 31422848Allen KJD, Hooley JM. Negative Emotional Action Termination (NEAT): Support for a Cognitive Mechanism Underlying Negative Urgency in Nonsuicidal Self-Injury. Behav Ther. 2019 Sep;50(5):924-937. doi: 10.1016/j.beth.2019.02.001. Epub 2019 Feb 14.
- Background: PubMed 31195164McHugh CM, Chun Lee RS, Hermens DF, Corderoy A, Large M, Hickie IB. Impulsivity in the self-harm and suicidal behavior of young people: A systematic review and meta-analysis. J Psychiatr Res. 2019 Sep;116:51-60. doi: 10.1016/j.jpsychires.2019.05.012. Epub 2019 May 17.
- Background: PubMed 25265242Ackerman JP, McBee-Strayer SM, Mendoza K, Stevens J, Sheftall AH, Campo JV, Bridge JA. Risk-sensitive decision-making deficit in adolescent suicide attempters. J Child Adolesc Psychopharmacol. 2015 Mar;25(2):109-13. doi: 10.1089/cap.2014.0041. Epub 2014 Sep 29.
- Background: PubMed 18570698Oldershaw A, Grima E, Jollant F, Richards C, Simic M, Taylor L, Schmidt U. Decision making and problem solving in adolescents who deliberately self-harm. Psychol Med. 2009 Jan;39(1):95-104. doi: 10.1017/S0033291708003693. Epub 2008 Jun 23.
- Background: PubMed 23357208Chamberlain SR, Odlaug BL, Schreiber LR, Grant JE. Clinical and neurocognitive markers of suicidality in young adults. J Psychiatr Res. 2013 May;47(5):586-91. doi: 10.1016/j.jpsychires.2012.12.016. Epub 2013 Jan 26.
- Background: PubMed 20482935Fikke LT, Melinder A, Landro NI. Executive functions are impaired in adolescents engaging in non-suicidal self-injury. Psychol Med. 2011 Mar;41(3):601-10. doi: 10.1017/S0033291710001030. Epub 2010 May 19.
- Background: PubMed 26647872Gvirts HZ, Braw Y, Harari H, Lozin M, Bloch Y, Fefer K, Levkovitz Y. Executive dysfunction in bipolar disorder and borderline personality disorder. Eur Psychiatry. 2015 Nov;30(8):959-64. doi: 10.1016/j.eurpsy.2014.12.009. Epub 2015 Oct 21.
- Background: PubMed 29593586Thompson C, Ong ELC. The Association Between Suicidal Behavior, Attentional Control, and Frontal Asymmetry. Front Psychiatry. 2018 Mar 14;9:79. doi: 10.3389/fpsyt.2018.00079. eCollection 2018.
- Derived from this study: PubMed 42773477Thylander C, Nilsson M, van Westen D, Bjorkstrand J, Westling S. Elevated Negative Affectivity and Psychoticism in individuals with active Nonsuicidal Self-Injury (NSSI) compared with individuals with previous or no NSSI. Borderline Personal Disord Emot Dysregul. 2026 Sep 22;13(1):28. doi: 10.1186/s40479-026-00373-z.
- Individual participant dataSharing planned: Undecided. Data not protected by Swedish law of patient secrecy can be shared after analyses has been completed and man scripts accepted for publication
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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. This study is not recruiting at the moment.
Sofie Westling, MD PhD principal investigator
Region Skane
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, Deliberate and Non-Suicidal Self Injury, 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 13 inclusion and 21 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: finished, as of the sponsor's last update on 14 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive functioning (time frame: Up to 1 hour). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04905797, which also lists 11 linked publications.
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 14 May 2026.