[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-suicidal-self-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-suicidal-self-injury":62},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,48,74,110,135,161,184,204,231,268],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100648201","group-treatment-for-self-harming-adolescents-and-their-parents-a-randomized-controlled-trial-100648201",false,"NCT07720063","Group Treatment for Self-harming Adolescents and Their Parents: a Randomized Controlled Trial","A Randomised Controlled Trial of Group Emotion Regulation for Adolescent Self-harm (the ERA-study)","ERA","Inclusion Criteria:\n\n* Age: 13 - 17 years\n* At least 5 instances of NSSI in the past year, and at least one during the past month\n* ≥5 episodes of NSSI in the past year, including ≥1 in the past month\n* If receiving antidepressant, central stimulants or neuroleptic medication, dose must be stable for least 6 weeks prior to inclusion\n* At least one participating caregiver\n* Sufficient Swedish language proficiency (adolescent and caregiver)\n* Regular access to a smartphone for SMS-based assessment\n\nExclusion Criteria:\n\n* Intellectual disability or a severe psychiatric disorder requiring immediate treatment (e.g., psychosis, bipolar disorder type 1, anorexia nervosa, alcohol\u002Fsubstance dependence) or conditions that prevent participation (e.g., severe social anxiety, selective mutism)\n* Acute suicide risk (i.e., current suicide plans) or recent suicide attempt\n* Previous or ongoing structured emotion regulation treatment involving at least 3 sessions during the past 12 months\n* Previous or ongoing structured emotion regulation treatment (≥3 sessions within past 12 months)\n* Social circumstances preventing participation or require immediate action (e.g., domestic violence, abuse and\u002For neglect in the family, inpatient care)\n* Ongoing structured psychological treatment targeting NSSI","ALL","13 Years","17 Years",{"count":21,"type":22},180,"ESTIMATED","INTERVENTIONAL",[25],"NA","Adolescent non-suicidal self-injury (NSSI) is common, strongly associated with psychiatric comorbidity and an increased risk of future suicide attempt. Although interventions targeting emotion regulation have been shown to reduce NSSI in both adults and adolescents few, are available within routine child and adolescent mental health services (CAMHS). Emotion Regulation for Adolescents (ERA), adapted from an evidence-based adult intervention is a brief group-based treatment designed to increase access to effective, evidence-based care for adolescents with NSSI. A large-scale randomised controlled trial (RCT) is needed to establish its efficacy and strengthen the evidence base for emotion regulation interventions for adolescent NSSI.\n\nThe overall aim of this project is to increase the availability of evidence-based psychological treatments for adolescent NSSI by developing and evaluating Emotion Regulation for Adolescents (ERA), a novel behavioural and acceptance-based intervention. The main objectives are to establish the efficacy, cost-effectiveness, and long-term outcomes of ERA for adolesent NSSI in two arm RCT comparing ERA with an active control condition (FUNK) as well as to investigate potential mediators such as emotion regulation and self-criticism.",[28,29,30,31,32],"Self-Harm","Self-Harm, Deliberate","Self-harm Behavior","Non-Suicidal Self Injury","Non-suicidal Self-injury (NSSI)",[34,35,36],"emotion regulation group therapy","non-suicidal self-injury (NSSI)","randomized controlled trial","NOT_YET_RECRUITING","2026-08-17",{"date":40,"type":41},"2026-08-18","ACTUAL",{"date":38,"type":22},{"date":44,"type":22},"2034-12-31",{"name":46,"class":47},"Karolinska Institutet","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100525847","intervention-effect-of-high-definition-transcranial-alternating-current-stimulation-hd-tacs-on-non-suicidal-self-injury-nssi-100525847","NCT06127056","Intervention Effect of High-Definition Transcranial Alternating Current Stimulation (HD-tACS) on Non-suicidal Self-injury (NSSI)","Inclusion Criteria:\n\nThe patients were diagnosed by 2 or more senior clinical psychiatrists, meeting DSM-V criteria, and having 1 or more non-suicidal self-injurious behaviors in the last 6 months.\n\n12-18 years of age.\n\nThe medicine has not changed in the 4 weeks prior to or after this study, and if it has to be changed, the treatment medication is required to be at a subtherapeutic dosage level.\n\nExclusion Criteria:\n\nThe patient has suicidal ideation or has committed suicidal behavior\n\nT1 or T2 weighted phase magnetic resonance images show focal brain lesions\n\npatients had neurological disorders such as epilepsy, or serious physical illnesses\n\npatients had a history of substance abuse and drug dependence in the last 6 months or use of anticonvulsant drugs in the last 3 months\n\npatients had received radial cranial electrical stimulation or magnetic stimulation treatment in the last 3 months or received electroconvulsive therapy in the last 6 months\n\npatients had previous significant head trauma or EEG abnormality in the last 1 month\n\nbody-mounted devices unsuitable for treatment, such as pacemakers, artificial valves, and other metal implants.","12 Years","18 Years",{"count":57,"type":22},40,[25],"To investigate the intervention effect of high-definition transcranial alternating current stimulation (HD-tACS) on patients with Non-suicidal Self-injury (NSSI) and its underlying neural mechanism by magnetic resonance imaging (MRI).",[61,62],"Transcranial Alternating Current Stimulation","Non-suicidal Self-injury","RECRUITING","2026-07-20",{"date":66,"type":41},"2026-07-22",{"date":68,"type":41},"2023-05-01",{"date":70,"type":22},"2026-08-30",{"name":72,"class":47},"Anhui Medical University",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":54,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":73},"100639512","integrated-motivational-interviewing-and-rational-emotive-behavior-therapy-intervention-for-non-suicidal-self-injury-among-malaysian-primary-school-students-a-feasibility-trial-protocol-100639512","NCT07627061","Integrated Motivational Interviewing and Rational Emotive Behavior Therapy Intervention for Non-Suicidal Self-Injury Among Malaysian Primary School Students: A Feasibility Trial Protocol","The Feasibility and Preliminary Effects of an Integrated Motivational Interviewing and Rational Emotive Behavior Therapy (MI-REBT) Intervention on Non-Suicidal Self-Injury, Emotional Dysregulation, and Readiness for Change Among Malaysian Primary School Students: A Trial Protocol","MIND-SET","Inclusion Criteria:\n\n* Primary school students aged 12 years old.\n* Students identified with Non-Suicidal Self-Injury (NSSI) behaviour through school mental health screening and assessment procedures.\n* Able to understand and participate in group counselling sessions.\n* Written informed consent obtained from parents or guardians.\n* Assent obtained from participating students.\n\nExclusion Criteria:\n\n* Students currently receiving intensive psychiatric treatment or psychological -intervention for severe mental health conditions.\n* Students identified with active suicidal intent requiring immediate clinical intervention.\n* Students with severe cognitive or developmental impairments that may interfere with participation in group intervention activities.\n* Students who are unable to attend the scheduled intervention sessions consistently.",{"count":83,"type":22},105,[25],"This study aims to evaluate the feasibility and preliminary effects of the MIND-SET Intervention Module, an integrated Motivational Interviewing and Rational Emotive Behavior Therapy (MI-REBT) intervention, among Malaysian primary school students involved in Non-Suicidal Self-Injury (NSSI) behaviour. The module is designed to reduce self-injurious behaviour, improve emotional regulation, and enhance readiness for change among 12-year-old students in school settings. This study will use a quasi-experimental design involving three groups: a MIND-SET intervention group, a PRISMA Mental Health Module group, and a treatment-as-usual group. Data will be collected at pre-intervention, post-intervention, and follow-up stages using validated psychological instruments. The findings are expected to support the development of culturally responsive, school-based mental health interventions for children involved in NSSI behaviour in Malaysia.",[87,88],"Non-Suicidal Self-Injury","Emotional Dysregulation",[90,91,92,93,94,95,96,97,98,99,100],"Non-suicidal self-injury","NSSI","Primary school students","Children","Emotional dysregulation","Readiness for change","Motivational Interviewing","Rational Emotive Behavior Therapy","School counselling","Malaysia","MIND-SET Intervention Module","2026-05-31",{"date":103,"type":41},"2026-06-04",{"date":105,"type":22},"2026-08",{"date":107,"type":22},"2026-12",{"name":109,"class":47},"Universiti Utara Malaysia",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":73},"100635597","tis-for-nssi-in-adolescent-depression-100635597","NCT07554755","TIS for NSSI in Adolescent Depression","Efficacy and Safety of Temporal Interference Stimulation on Non-suicidal Self-injury Behaviors in Adolescents With Depression","Inclusion Criteria:\n\n1. Meet the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders 5th Edition) diagnostic criteria for major depressive disorder.\n2. Patients aged 12-22 years with at least one guardian to monitor them for 3 months\n3. HAMD-17 Total score ≥18\n4. Patients who had two or more non-suicidal self-injury behaviors meeting the 5.DSM-5 diagnostic criteria in the 2 weeks before admission (NSSI behavior of more than 5 days in the past year)\n\n6.Obtain informed consent from patients and guardians\n\n\\-\n\nExclusion Criteria:\n\n1. Substance abusers such as psychoactive drugs or alcohol.\n2. Severe physical disability and unable to complete follow-up.\n3. Comorbid other major mental illnesses that meet the DSM-5 criteria, such as bipolar disorder, schizophrenia, mental retardation, dementia, severe cognitive impairment, attention deficit hyperactivity disorder, etc.\n4. Suffering from any severe physical disease, neurological disease, traumatic brain injury, etc, that affects the structure or function of the brain in the lifetime.\n\n   Unable to read, understand and complete the assessment or to cooperate with the investigators.\n5. Any implants covering a pacemaker, metallic or magnetic objects in the body, or other conditions not suitable for TIS.\n6. Those who have received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) or TMS within 3 months before baseline.\n7. Other examination abnormalities considered to be inappropriate by investigators.\n\n   \\-","22 Years",{"count":119,"type":22},60,[25],"Temporal Interference Stimulation (TIS) has been successfully used to help patients with depression. However, its role in alleviating self injuries remained uncertain. This trial will compare the effectiveness of TIS to a placebo control on non-suicidal self injury (NSSI) in patients with major depressive disorder(MDD).",[123,124,125],"Temporal Interference Stimulation","Non Suicidal Self Injury","Major Depressive Disorder","2026-04-23",{"date":128,"type":41},"2026-04-28",{"date":130,"type":22},"2026-04-30",{"date":132,"type":22},"2027-01-31",{"name":134,"class":47},"The Second Hospital of Anhui Medical University",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":117,"enrollmentInfo":142,"targetDuration":4,"studyType":23,"phases":144,"briefSummary":145,"conditions":146,"keywords":147,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":73},"100630371","effects-of-tavns-combined-with-tacs-on-adolescents-with-non-suicidal-self-injury-100630371","NCT07486804","Effects of taVNS Combined With tACS on Adolescents With Non-Suicidal Self-Injury","Effects of Combined taVNS and tACS on Adolescents With Non-Suicidal Self-Injury: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Meet the proposed diagnostic criteria for non-suicidal self-injury (NSSI) in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with ≥5 documented self-injury episodes and at least one incident within the past month as assessed by the Adolescent Non-Suicidal Self-Injury Assessment Questionnaire (ANSAQ)\n* Aged 12-18 years\n* Right-handed\n* Possess formal education experience sufficient to comprehend experimental protocols\n* Normal or corrected-to-normal binocular visual acuity\n* Voluntarily participate with legal guardians providing written informed consent\n\nExclusion Criteria:\n\n* Montreal Cognitive Assessment (MoCA) score \\\u003C 26\n* History of suicide attempts\n* History of epilepsy, brain surgery, tumors, or clinically significant head trauma\n* History of substance abuse or severe physical diseases\n* Received physical or psychological interventions within the past three months",{"count":143,"type":22},90,[25],"NSSI behavior is highly prevalent among adolescents, and its mechanisms are closely associated with attentional bias toward self-injury-related information and impulsivity, both of which may be related to reduced dlPFC activation levels. Introducing taVNS as a priming stimulus to pre-regulate brain state and optimize subsequent tACS treatment response provides a novel approach to addressing inconsistent intervention effects. Simultaneously, this facilitates a shift in the brain from passive stimulus reception to active state regulation, offering important theoretical foundations for developing more precise and efficient cross-modal neuromodulation therapies.This study aims to systematically validate the efficacy of a combined protocol using taVNS as a priming modality followed by tACS over the left dlPFC through a randomized controlled trial (RCT). The investigators hypothesize that:\n\n① Compared to tACS intervention alone, this combined approach will not only demonstrate non-inferiority in overall therapeutic efficacy but, more importantly, significantly reduce inter-individual variability in treatment response to tACS. This would mitigate the issue of high clinical response heterogeneity and enhance the stability and predictability of treatment outcomes.\n\n② Early behavioral biomarkers of intervention response are anticipated: Immediate improvements in attentional bias following a single combined intervention session will significantly predict reductions in the frequency and intensity of Non-Suicidal Self-Injury (NSSI) after a full course (14 sessions) of treatment. This suggests that early positive changes in cognitive function could serve as valid indicators predicting long-term clinical efficacy, offering a critical time window for implementing individualized treatment adjustments.\n\n③ The study will elucidate the effects of the taVNS-primed combined tACS treatment on neuroimaging mechanisms in adolescents with NSSI.",[62],[148,149,150,151,152],"non-suicidal self-injury","transcranial alternating current stimulation","taVNS","tACS","state-dependant","2026-03-19",{"date":155,"type":41},"2026-03-23",{"date":157,"type":41},"2025-10-16",{"date":159,"type":22},"2027-10-01",{"name":72,"class":47},{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":23,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":4},"100618888","evidence-based-digital-cbt-for-nonsuicidal-self-injury-100618888","NCT07337473","Evidence-based Digital CBT for Nonsuicidal Self-Injury","Effect of Evidence-based Digital Cognitive Behavior Therapy for Adolescents With Nonsuicidal Self-Injury Disorder: A Randomized Clinical Trial","Inclusion Criteria:\n\n* 5 nonsuicidal self-injury episodes past year\n* 1 nonsuicidal self-injury episodes past month having at least one parent who committed to participate in the program\n\nExclusion Criteria:\n\nSevere suicidal ideation a diagnosis of psychotic or ongoing (past month) substance dependence the presence of co-occurring psychological disorders that required immediate treatment (i.e., severe anorexia nervosa)","25 Years",{"count":170,"type":22},100,[25],"To evaluate if evidence-based digital cognitive behaviour therapy for adolescents is an efficacious treatment when delivered as an adjunctive treatment to treatment as usual, compared to a control group consisting of treatment as usual.",[124,174],"Cognitive Behavior Therapy","2026-01-04",{"date":177,"type":41},"2026-01-13",{"date":179,"type":22},"2026-01-31",{"date":181,"type":22},"2027-01-30",{"name":183,"class":47},"Peking University Sixth Hospital",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":117,"enrollmentInfo":190,"targetDuration":4,"studyType":23,"phases":191,"briefSummary":192,"conditions":193,"keywords":195,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":203,"locationsCount":73},"100604700","the-impact-of-beta-band-transcranial-alternating-current-stimulation-tacs-on-impulse-inhibition-in-adolescents-with-non-suicidal-self-injury-100604700","NCT07152925","The Impact of Beta-band Transcranial Alternating Current Stimulation (tACS) on Impulse Inhibition in Adolescents With Non-suicidal Self-injury","Inclusion Criteria:\n\n* 1\\) Meet the proposed diagnostic criteria for non-suicidal self-injury (NSSI) in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with ≥5 documented self-injury episodes and at least one incident within the past month as assessed by the Adolescent Non-Suicidal Self-Injury Assessment Questionnaire (ANSAQ); 2) Aged 12-18 years; 3) Right-handed; 4) Possess formal education experience sufficient to comprehend experimental protocols; 5) Normal or corrected-to-normal binocular visual acuity; 6) Voluntarily participate with legal guardians providing written informed consent.\n\nExclusion Criteria:\n\n* 1\\) Montreal Cognitive Assessment (MoCA) score \\\u003C 26; 2) History of suicide attempt(s); 3) Medical history of epilepsy, brain surgery, intracranial tumors, metal implants in the skull, or clinically significant head trauma; 4) History of substance use disorder, brain injury, severe somatic diseases, psychiatric disorders, or comorbid DSM-5 psychiatric conditions; 5) Prior receipt of transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or repetitive transcranial magnetic stimulation (rTMS) within the past 3 months",{"count":119,"type":22},[25],"This clinical trial aims to determine whether beta-band transcranial alternating current stimulation (tACS) can improve impulse inhibition in adolescents with non-suicidal self-injury (NSSI) and to evaluate its safety. The primary questions it seeks to answer are:\n\n* Can beta-band tACS significantly reduce the frequency of self-injury and scores on impulsivity scales in adolescents with NSSI?\n* What discomfort or medical issues may participants experience during tACS intervention?\n\nResearchers will compare beta-band tACS with sham stimulation (a procedure that mimics the real stimulation without delivering effective current) to verify its efficacy.\n\nParticipants will:\n\n* Receive two sessions of either tACS or sham stimulation daily, spaced 4 hours apart, for 7 consecutive days (14 sessions in total).\n* Undergo scale assessments, behavioral tasks, and eye-tracking tests before and after the intervention.\n* Record any self-injury episodes and adverse reactions, with continuous monitoring and psychological support provided by a professional team.",[194,62],"Depression Disorders",[196,148,149],"Depression","2025-08-26",{"date":199,"type":41},"2025-09-03",{"date":201,"type":41},"2025-03-01",{"date":101,"type":22},{"name":72,"class":47},{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":213,"conditions":214,"keywords":217,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":73},"100524271","which-factors-are-relevant-for-treatment-outcome-in-dialectical-behaviour-therapy-for-borderline-personality-disorder-100524271","NCT06106555","Which Factors Are Relevant for Treatment Outcome in Dialectical Behaviour Therapy for Borderline Personality Disorder?","Vilka Faktorer påverkar Behandlingsutfall Vid Dialektisk Beteendeterapi för Borderline Personlighetssyndrom?","Inclusion Criteria:\n\n* Borderline personality disorder as defined by the DSM-V (assessed with SCID or uquivalent).\n* Self-harm over the past 12 months\n* Offered DBT at the Lund adult psychiatric clinic\n\nExclusion Criteria:\n\n* Unable to read or communicate in Swedish",{"count":170,"type":22},"OBSERVATIONAL","The objective of this project is to investigate factors that contribute to the success and lack of success in DBT among individuals with BPD and a history of self-harm in a clinical psychiatric setting.\n\n1. Do certain personality factors and identity disturbance predict the treatment outcome of DBT in individuals with BPD?\n2. Do changes in identity disturbance, self-hate, or emotion regulation mediate the treatment outcome of DBT in individuals with BPD?\n3. Do specific personality profiles moderate the treatment outcomes of DBT for individuals with BPD?\n4. When does the primary treatment effect occur, and does this effect persist after a 12-month follow-up period?",[215,62,216],"Borderline Personality Disorder","Deliberate Self Harm",[215,218,219,62,220,221],"Dialectical Behavior Therapy","Deliberate Self-Harm","Self-concept","Personality","2025-06-24",{"date":224,"type":41},"2025-06-25",{"date":226,"type":41},"2023-09-01",{"date":228,"type":22},"2027-08-31",{"name":230,"class":47},"Region Skane",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":239,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":240,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":242,"conditions":243,"keywords":249,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":267},"100498100","self-harm-behaviour-among-the-most-at-risk-adolescents-100498100","NCT05765864","Self-harm Behaviour Among the Most At-risk Adolescents","Influences on and Prevention of Self-harm Behaviour Among the Most At-risk Adolescents","SH-MARA","CLINICAL GROUP:\n\nInclusion Criteria:\n\n* Suicidality\n* Self-harming with no intention to die\n\nExclusion Criteria:\n\n* Confirmed acute psychotic disorder\n* Intellectual disability\n* Severe physical illness (e.g. cardiovascular or renal disease)\n* Disease of the central nervous system (e.g. encephalitis, brain injury or haemorrhage, epilepsy)\n* Acute poisoning (including with psychoactive substances)\n\nCONTROL GROUP:\n\nInclusion Criteria:\n\n\\- Age 13-19\n\nExclusion criteria:\n\n* Suicidality\n* Self-harming with no intention to die\n* Known mental disorder (e.g. depression, bipolar disorder, schizophrenia, intellectual disability)\n* Severe physical illness (e.g. cardiovascular or renal disease)\n* Disease of the central nervous system (e.g. encephalitis, brain injury or haemorrhage, epilepsy)\n* Acute poisoning (including with psychoactive substances)\n* Mental disorder, history of suicidality or self-injurious behaviour in a first-degree relative (a parent or a sibling).",true,{"count":241,"type":22},400,"In the proposed study, three objectives will be pursued:\n\n1. To develop a method to identify more effectively the acute and long-term risk of adolescents with the most threatening self-harm behaviours.\n2. To identify the factors that influence the risk of self-harm behaviours and the success of treatment\u002Ftreatment of these behaviours in the most at-risk adolescents (changes in these factors).\n3. Develop guidelines for more effective treatment of the most at-risk adolescents.\n\nFor this purpose, a sample of approximately 200 young people who will be hospitalised for suicide risk (the most at risk in Slovenia) and an approximately equal number of healthy adolescents will be included. At inclusion, the presence of several factors will be assessed by reviewing demographic data, clinical diagnosis, self-assessment questionnaires and clinical psychological tests (CSSRS, B-NSSI-AT, ISAS, LPFS-BF2.0, BPFSC-11, TSCC, PAI, ECR-RS, DASA-YV, ASHRS), social assessment, and blood sampling for genetic analyses (DNA isolation, sequencing, nucleotide sequence recognition, quantification and evaluation of short tandem repeats, identification of methylation sites). Longitudinal tracking of autoaggressive events and heteroaggressive events during hospitalisation will be performed and recorded on an ongoing basis. The risk and protective factors of the adolescents most at risk will be compared with a control group of adolescents. The same factors will be reassessed in the most at-risk adolescents after 6 and 18 months of treatment as usual. The data will be collected in a data entry and storage system that will ensure the privacy of the data entered in accordance with the GDPR.\n\nThis will allow the investigators to identify young people at particular risk of severe self-harm behaviour more reliably, to target them for more intensive and effective treatment, and thus to improve their safety, quality of life and prognosis in the short and long term.",[244,245,246,31,247,248],"Self-harm","Personality Disorder, Borderline","Epigenetic Disorder","Change; Mental","Difference, Individual",[250,251,252,253,148,254,255,256,257],"adolescent","deliberate self-harm","risk and protective factors","suicidal behavior","risk assessment","attachment","genetics","epigenetics","2025-03-26",{"date":260,"type":41},"2025-03-28",{"date":262,"type":41},"2023-03-23",{"date":264,"type":22},"2025-10",{"name":266,"class":47},"University of Ljubljana, Faculty of Medicine",2,{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":275,"targetDuration":4,"studyType":23,"phases":276,"briefSummary":277,"conditions":278,"keywords":281,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":267},"100532230","aitbs-for-nssi-and-suicide-in-adolescent-depression-100532230","NCT06210100","aiTBS for NSSI and Suicide in Adolescent Depression","Efficacy and Safety of Accelerated Intermittent Theta Burst Stimulation on Non-suicidal Self-injury and Suicide Behaviors in Adolescents With Unipolar or Bipolar Depression","Inclusion Criteria:\n\n1. Meet the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders 5th Edition) diagnostic criteria for major depressive disorder.\n2. Patients aged 12-18 years with at least one guardian to monitor them for 3 months\n3. HAMD-17 Total score ≥18\n4. Hospitalized patients who had two or more non-suicidal self-injury behaviors meeting the DSM-5 diagnostic criteria in the week before admission (NSSI behavior of more than 5 days in the past year, and a baseline DSHI score ≥2 )\n5. Obtain informed consent from patients and guardians\n\nExclusion Criteria:\n\n1. Substance abusers such as psychoactive drugs or alcohol.\n2. Severe physical disability and unable to complete follow-up.\n3. Comorbid other major mental illnesses that meet the DSM-5 criteria, such as bipolar disorder, schizophrenia, mental retardation, dementia, severe cognitive impairment, attention deficit hyperactivity disorder, etc.\n4. Suffering from any severe physical disease, neurological disease, traumatic brain injury, etc, that affects the structure or function of the brain in the lifetime.\n5. Unable to read, understand and complete the assessment or to cooperate with the investigators.\n6. Any implants covering a pacemaker, metallic or magnetic objects in the body, or other conditions not suitable for rTMS.\n7. A history or family history of epilepsy and other contraindications to TMS.\n8. Daily use of benzodiazepines (more than 2mg\u002Fd), theophylline, stimulants such as methylphenidate, anticonvulsants, etc.\n9. Those who have received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) or TMS within 3 months before baseline.\n10. Other examination abnormalities considered to be inappropriate by investigators.",{"count":119,"type":22},[25],"Repetitive transcranial magnetic stimulation (rTMS) has been successfully used to help patients with treatment resistant depression. However, its role in alleviating self injuries with and without suicidal ideation remained uncertain. This trial will compare the effectiveness of active accelerated intermittent theta burst stimulation (aiTBS) rTMS to a placebo control on non-suicidal self injury (NSSI) and suicidal attempts in patients with major depressive disorder.",[124,279,280],"Suicidal Ideation","Suicide and Self-harm",[91,282,283],"MDD","TMS","2024-08-15",{"date":286,"type":41},"2024-08-16",{"date":288,"type":41},"2024-01-18",{"date":290,"type":22},"2025-02-01",{"name":292,"class":47},"Central South University"]