NCT04905797

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

April 30, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

4.7 years

First QC Date

April 29, 2021

Last Update Submit

August 1, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (4)

Deliberate self-harm

Individuals with psychiatric disorders and persistent DSH

Diagnostic Test: Emotional Stop Signal TaskDiagnostic Test: Magnetic Resonance ImagingOther: 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

Diagnostic Test: Emotional Stop Signal TaskDiagnostic Test: Magnetic Resonance ImagingOther: 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

Diagnostic Test: Emotional Stop Signal TaskDiagnostic Test: Magnetic Resonance ImagingOther: 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

Diagnostic Test: Emotional Stop Signal TaskDiagnostic Test: Magnetic Resonance ImagingOther: 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

Interventions

Emotional Stop Signal Task (modified version from CANTAB). Outcome Measure is commission and omission errors - higher score (percentage) indicate worse performance.

Clinical cases who ceased self-harmClinical cases with no self-harmDeliberate self-harmHealthy controls

Functional Magnetic Resonance Imaging (fMRI) Diffusion Tensor Imaging (DTI) Volumetry

Clinical cases who ceased self-harmClinical cases with no self-harmDeliberate self-harmHealthy controls

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.

Clinical cases who ceased self-harmClinical cases with no self-harmDeliberate self-harmHealthy controls

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.

Clinical cases who ceased self-harmClinical cases with no self-harmDeliberate self-harmHealthy controls

The estimate of time where an individual can successfully inhibit their responses 50% of the time.

Clinical cases who ceased self-harmClinical cases with no self-harmDeliberate self-harmHealthy controls

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.

Clinical cases who ceased self-harmClinical cases with no self-harmDeliberate self-harmHealthy controls

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.

Clinical cases who ceased self-harmClinical cases with no self-harmDeliberate self-harmHealthy controls

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.

Clinical cases who ceased self-harmClinical cases with no self-harmDeliberate self-harmHealthy controls

1. 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.

Clinical cases who ceased self-harmClinical cases with no self-harmDeliberate self-harmHealthy controls

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.
  • 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
  • Adults 18-65 years.
  • Ability to leave informed consent.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psykiatri och habilitering, Region SkĂ¥ne

Lund, SkĂ¥ne County, 22185, Sweden

RECRUITING

Related Publications (10)

  • 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.

    PMID: 25510907BACKGROUND
  • Allen 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.

    PMID: 27888700BACKGROUND
  • Allen 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.

    PMID: 31422848BACKGROUND
  • McHugh 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.

    PMID: 31195164BACKGROUND
  • Ackerman 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.

    PMID: 25265242BACKGROUND
  • Oldershaw 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.

    PMID: 18570698BACKGROUND
  • Chamberlain 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.

    PMID: 23357208BACKGROUND
  • Fikke 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.

    PMID: 20482935BACKGROUND
  • Gvirts 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.

    PMID: 26647872BACKGROUND
  • Thompson 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.

    PMID: 29593586BACKGROUND

MeSH Terms

Conditions

Self-Injurious BehaviorSuicide, AttemptedPersonality Disorders

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSuicideMental Disorders

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Sofie Westling, MD PhD

    Region SkĂ¥ne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofie Westling, MD PhD

CONTACT

Christina Thylander, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, associate professor

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 28, 2021

Study Start

April 30, 2021

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

August 6, 2025

Record last verified: 2025-08

Locations