Aspects of Self-harm - Cognition, Imaging and Treatability

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.

Study Overview

• Status: Recruiting
• Conditions: Personality Disorders; Self-Harm, Deliberate; Non-Suicidal Self Injury; Attempt Suicide
• Intervention / Treatment: 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

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:

1. individuals with psychiatric disorders and persistent DSH
2. individuals with psychiatric disorders who have ceased DSH
3. individuals with psychiatric disorders who never had DSH
4. 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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Sofie Westling, MD PhD; Phone Number: +46174901; Email: sofie.westling@med.lu.se
• Study Contact Backup: Name: Christina Thylander, MD; Email: Christina.thylander@med.lu.se

Study Locations

• Sweden
  • Skåne
    • Lund, Skåne, Sweden, 22185
      • Recruiting
      • Psykiatri och habilitering, Region Skåne
      • Contact: Sofie Westling, MD PhD; Email: sofie.westling@med.lu.se
      • Contact: Christina Thylander, MD; Email: Christina.thylander@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Deliberate self-harm; Individuals with psychiatric disorders and persistent DSH	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); 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.; Diagnostic test: Spatial Working Memory Test (CANTAB); 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.; Diagnostic test: Multitasking Test (CANTAB); 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.; Diagnostic test: Cambridge Gambling Task 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.
Clinical cases who ceased self-harm; Individuals with psychiatric disorders who have ceased DSH	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); 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.; Diagnostic test: Spatial Working Memory Test (CANTAB); 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.; Diagnostic test: Multitasking Test (CANTAB); 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.; Diagnostic test: Cambridge Gambling Task 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.
Clinical cases with no self-harm; Individuals with psychiatric disorders who never had DSH	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); 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.; Diagnostic test: Spatial Working Memory Test (CANTAB); 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.; Diagnostic test: Multitasking Test (CANTAB); 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.; Diagnostic test: Cambridge Gambling Task 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.
Healthy controls; Healthy controls who never had DSH	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); 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.; Diagnostic test: Spatial Working Memory Test (CANTAB); 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.; Diagnostic test: Multitasking Test (CANTAB); 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.; Diagnostic test: Cambridge Gambling Task 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Lund University
• Investigators: Principal Investigator: Sofie Westling, MD PhD, Region Skane

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: May 23, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Personality Disorders; Suicide; Self-Injurious Behavior
• Other Study ID Numbers: 2020-02732

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data not protected by Swedish law of patient secrecy can be shared after analyses has been completed and man scripts accepted for publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No