Aspects of Self-harm - Cognition, Imaging and Treatability (NCT04905797) | Clinical Trial Compass
CompletedNot Applicable
Aspects of Self-harm - Cognition, Imaging and Treatability
Sweden316 participantsStarted 2021-04-30
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 psychiatri…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.