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RECRUITING
NCT04905797

Aspects of Self-harm - Cognition, Imaging and Treatability

Sponsor: Region Skane

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2021-04-30

Completion Date

2025-12-31

Last Updated

2025-08-06

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Emotional Stop Signal Task

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

DIAGNOSTIC_TEST

Magnetic Resonance Imaging

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

OTHER

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.

DIAGNOSTIC_TEST

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

Stop Signal Task (CANTAB)

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

DIAGNOSTIC_TEST

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

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

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

Cambridge Gambling Task Test

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.

Locations (1)

Psykiatri och habilitering, Region Skåne

Lund, Skåne County, Sweden