[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"self-harm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:self-harm":84},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,46,71,98,139,165,192,219,248,282,305,330,359,380,421,450,484,516,541],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100637007","internet-delivered-emotion-regulation-individual-therapy-or-adolescents-ierita-with-self-injury-within-child-and-adolescent-mental-health-services-100637007",false,"NCT07573085","Internet-delivered Emotion Regulation Individual Therapy or Adolescents (IERITA) With Self-injury Within Child and Adolescent Mental Health Services","Inclusion Criteria:\n\n* 13-17 years old\n* At least one self-injury episode in the past three months\n* A parent willing to engage in the parent program\n\nExclusion Criteria:\n\n* Immediate suicide risk\n* Global functioning corresponding to a rating ≤40 of the Children's Global Assessment Scale (CGAS)\n* Social problems needing immediate intervention (e.g., violence within the family)\n* Ongoing dialectical behavior therapy for adolescents","ALL","13 Years","17 Years",{"count":19,"type":20},341,"ESTIMATED","INTERVENTIONAL",[23],"NA","The overall purpose of the study is to implement and evaluate IERITA (Internet-delivered Emotion Regulation Individual Therapy for Adolescents) within child and adolescent mental health services for adolescents engaging in nonsuicidal self-injury (NSSI) and optimize treatment outcomes for those adolescents at risk of non-remission (continued NSSI).",[26,27],"Nonsuicidal Self-Injury","Self-Harm",[29,30,31,32],"Nonsuicidal self-injury","Internet-delivered treatment","Self-harm","Adolescence","RECRUITING","2026-06-05",{"date":36,"type":37},"2026-06-08","ACTUAL",{"date":39,"type":37},"2026-05-22",{"date":41,"type":20},"2040-12",{"name":43,"class":44},"Karolinska Institutet","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":15,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":45},"100523735","intractable-self-harm-what-support-is-effective-100523735","NCT06099561","Intractable Self-harm-What Support is Effective?","Svårbehandlat självskadebeteende-Vilka Insatser är Effektiva?","Inclusion Criteria:\n\n* Having tried or made serious attempt to try at least two different interventions with evidence to reduce self-harm, without sufficient reduction in suffering or self-harm\n\nExclusion Criteria:\n\n* Need for translation services to complete measures or interviews\n* Not able to complete measures or interviews","18 Years",{"count":55,"type":20},30,"OBSERVATIONAL","The aim of this project is to evaluate a novel treatment program for individuals with intractable and lethal self-harm.\n\nThe main questions are:\n\n1: Is there, in individuals with intractable self-harm, a relevant improvement in daily functioning and is this improvement related to the provided interventions?\n\nThe secondary research questions are:\n\n2\\. Is there, in individuals with intractable self-harm, a relevant improvement in frequency and severity of self-harm?\n\n3\\. Is there, in individuals with intractable self-harm, a relevant improvement in voluntary hospital admissions?\n\n4\\. Is there, in individuals with intractable self-harm, a relevant improvement in compulsary hospital admissions?\n\n5\\. Is there, in individuals with intractable self-harm, a relevant improvement in the use of medication pro re nata?\n\n6\\. Is there, in individuals with intractable self-harm, a relevant improvement in cost-effectiveness related to the provided interventions?",[31],[60,61],"Deliberate self-harm","Suicide","2026-04-28",{"date":64,"type":37},"2026-04-29",{"date":66,"type":37},"2023-09-01",{"date":68,"type":20},"2026-12-31",{"name":70,"class":44},"Region Skane",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":15,"minAge":78,"maxAge":53,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":94,"leadSponsor":96,"locationsCount":45},"100621279","the-impact-of-a-nursing-care-program-based-on-human-caring-theory-on-adolescents-with-self-harm-100621279","NCT07368556","The Impact of a Nursing Care Program Based on Human Caring Theory on Adolescents With Self-harm","The Effect of a Nursing Care Program Based on Human Caring Theory on Self-Esteem, Coping, and Self-Compassion in Adolescents With Self-Harm","Inclusion Criteria:\n\nThe study will include adolescents who:\n\n* are aged 14-18 years,\n* volunteer to participate in the study, and\n* have self-harm according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria.\n\nExclusion Criteria:\n\n* Adolescents with speech, hearing, comprehension, or visual impairments, as well as those receiving psychosocial support during the research process, will not be included in the study.\n\nSampling Exclusion Criteria:\n\n* Adolescents who did not participate in all interviews\n* Were admitted to the Child and Adolescent Psychiatry clinic for treatment during the research process,\n* Did not wish to continue participating in the interviews will be excluded from the study.","14 Years",{"count":80,"type":20},48,[23],"The aim of this study is to examine the effect of a Nursing Care Program based on Human Caring Theory on self-esteem, coping, and self-compassion in adolescents exhibiting self-harming behavior.\n\nHypotheses of the research:\n\nH1-a: The self-esteem level of adolescents exhibiting self-harm in the intervention group that received the Human Caring Theory-Based Nursing Care Program differed significantly from the control group.\n\nH1-b: The self-compassion level of adolescents exhibiting self-harm in the intervention group that received the Human Caring Theory-Based Nursing Care Program differed significantly from the control group.\n\nH1-c: The coping level of adolescents exhibiting self-harm in the intervention group that received the Human Caring Theory-Based Nursing Care Program differed significantly from the control group.\n\nThis study is a randomized, controlled, single-blind experimental design. It will be conducted between March 2026 and March 2027 at the Child and Adolescent Mental Health and Diseases Outpatient Clinic of Antalya City Hospital with 48 adolescents (24 in the intervention group and 24 in the control group) who meet the inclusion criteria. The Human Caring Theory-Based Nursing Care Program will be applied individually and face-to-face to adolescents in the intervention group through structured therapeutic interviews. Data will be collected using a Personal Information Form, the Inventory of Statements About Self-injury, the Rosenberg Self-Esteem Scale, the Coping Scale for Adolescents, and the Short Form of the Self-Compassion Scale. Data analysis will be performed using the Statistical Package for Social Science (SPSS) 31.0 software package. It is believed that the Human Caring Theory-Based Nursing Care Program may be effective in improving self-esteem, self-compassion, and coping skills in adolescents exhibiting self-harm behavior.",[84],"Self Harm",[86,87,88,89],"self harm","adolescent","psychiatric nursing","randomized controlled trial","2026-03-18",{"date":92,"type":37},"2026-03-20",{"date":90,"type":37},{"date":95,"type":20},"2028-03",{"name":97,"class":44},"Akdeniz University",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":15,"minAge":53,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":108,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":45},"100533288","efficacy-effectiveness-and-implementation-of-jaspr-health-in-emergency-department--part-a-100533288","NCT06223867","Efficacy, Effectiveness, and Implementation of Jaspr Health in Emergency Department- Part A","Evaluation of Efficacy, Effectiveness, and Implementation of Jaspr Health's Digital Platform in Emergency Department for Patients With Suicidal Risk- Part A: Randomized Controlled Trial","Jaspr-PartA","Inclusion Criteria:\n\n* Positive for suicide risk on the Patient Safety Screener in the ED (active suicidal ideation int the past 2 weeks, or suicidal attempt in the past 6 months)\n* Cognitively and emotionally capable of consent and engaging in Jaspr app.\n* Reads English at 6th grade level.\n* Reliable telephone access.\n* Owns a smart phone\n* Lives in Massachusetts\n\nExclusion Criteria:\n\n* Prisoners or in state custody\n* Adults unable to consent\n* Patient \\\u003C18 yeas\n* Enrolled subjects during the 12 month follow-up period",{"count":107,"type":20},670,[23],"This Study will comprehensively evaluate a multi-component suicide prevention technology (Jaspr Health) that facilitates delivery of suicided-related evidence-based practices (EBPs) while replacing wasted waiting time with productive time in the Emergency Departments (EDs). The EBPs satisfy several key performance elements for systems adopting Zero Suicide.\n\nA Complementary Randomized Controlled Trial and Real-World Study for Efficacy, Effectiveness, and Implementation Study Design (CREID) will be used",[111,112,84],"Suicidal Ideation","Suicide Attempt",[61,27,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129],"Attempt","Ideation","Suicidal thought","Suicidal plan","Crisis intervention","Suicide prevention","Emotional support","Mental Health","Behavioral Health","Psychiatry","Emergency Department","Technology","Mobile Application","Implementation","Safety Plan","Lethal Means","2026-02-18",{"date":132,"type":37},"2026-02-20",{"date":134,"type":37},"2024-02-23",{"date":136,"type":20},"2028-03-31",{"name":138,"class":44},"University of Massachusetts, Worcester",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":15,"minAge":53,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":21,"phases":148,"briefSummary":149,"conditions":150,"keywords":153,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":45},"100622059","implementing-evidence-based-nursing-leadership-and-organizational-change-for-implementation-100622059","NCT07378696","Implementing Evidence-Based Nursing: Leadership and Organizational Change for Implementation","LOCI-FIN-P","Inclusion Criteria:\n\n* Nurse manager\n* Registered nurse\n* Practical nurse\n* Nurse director\n\nExclusion Criteria:\n\n• Other healtcare professionals",{"count":147,"type":20},300,[23],"This study aims to find out whether a leadership and organizational development program called the LOCI (Leadership and Organizational Change for Implementation) strategy can help nurses and their managers use the best available research in everyday care. Using evidence-based practice.\n\nPrevious work in the region showed that nurses and their managers want to use evidence-based practices but face challenges, such as unclear processes, limited support, and differences in skills. The LOCI strategy has helped leaders in other countries improve how new practices are introduced and supported. This study will test a version of LOCI adapted for Finnish healthcare settings.\n\nNurse managers and staff from selected hospital and elder care units will:\n\nTake part in leadership and training sessions. Receive individual and group mentoring. Work with their teams on plans that support introducing new, research-based ways of working.\n\nTwo evidence-based practices will be introduced:\n\nIn psychiatric units: A safety planning method to help prevent suicide among people receiving mental health care.\n\nIn elder care units: Better ways to identify and treat malnutrition among older adults.\n\nThe study involves:\n\nNurse managers Nursing staff Senior nurse leaders Specialist nurses who support the training\n\nThe study will run for one year. The LOCI program lasts nine months, followed by a three-month follow-up period.\n\nAssessment:\n\nHow well the adapted LOCI strategy works in practice (for example, whether participants find it useful).\n\nWhether leadership skills and workplace support for evidence-based practices improve.\n\nWhether the new care practices (suicide safety planning and malnutrition prevention) are used more often and more effectively.\n\nParticipants will complete questionnaires, take part in interviews or group discussions, and researchers will review documentation and care records to understand how the changes progress.\n\nThe study may help improve leadership skills, strengthen support for evidence-based practice, and improve care for patients in both mental health and elder care settings. The results may also help other healthcare organizations adopt similar approaches.\n\nThe study follows strict ethical and data protection rules. Survey participation is voluntary, and all personal information will be handled securely and confidentially. The care practices being introduced are already recommended in Finland and are part of normal care.",[151,27,152],"Leadership","Malnutrition Elderly",[127,154,155,151],"Evidence-based practice","Nursing","2026-02-02",{"date":158,"type":37},"2026-02-05",{"date":160,"type":37},"2026-01-15",{"date":162,"type":20},"2027-01",{"name":164,"class":44},"Jaakko Varpula",{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":53,"enrollmentInfo":172,"targetDuration":4,"studyType":21,"phases":174,"briefSummary":175,"conditions":176,"keywords":178,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":45},"100540302","dialectical-behavior-therapy-for-adolescents-with-self-harm-and-suicidal-behavior--an-open-trial-100540302","NCT06315075","Dialectical Behavior Therapy for Adolescents With Self-harm and Suicidal Behavior- an Open Trial","Dialectical Behavior Therapy for Adolescents With Self-harm and Suicidal Behavior- an Open","Inclusion Criteria:\n\n* Age 13-18 years\n* Ongoing or a history of self-harm the last six months; current suicidal behavior (suicidal thoughts or at least one suicide attempt within the previous six months); at least three criteria of Diagnostic and Statistical Manual -5 (DSM-5) Borderline personality disorder (BPD), or the self-destruction criterion of DSM-5 BPD in addition to minimum two subthreshold criteria as assessed by the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) (First et al., 2016)\n* Fluency in Norwegian\n* One parent\u002Ftrusted adult that can participate together with the adolescent.\n\nExclusion Criteria:\n\n* Intellectual disability\n* Significant learning or language impairments\n* Autism spectrum disorder\n* Anorexia Nervosa\n* Any psychotic disorder\n* Substance abuse disorder. These patients will be offered treatment as usual at their local outpatient clinic.",{"count":173,"type":20},140,[23],"The goal of this pre-post-follow-up study is to examine how well the treatment Dialectical behavior therapy for adolescents (DBT-A) with a duration of 20 weeks for adolescents with self-harm and suicidal behavior works in routine clinical practice. The main questions it aims to answer are:\n\n* to investigate how well DBT-A works after treatment and at 3-month follow-up, measured by episodes of self-harm, suicide attempts, depressive symptoms and quality of life, drop-out from treatment and number of possible participants who decline DBT-A.\n* to investigate how well DBT-A works at 12 months follow-up\n* to investigate whether pre-treatment factors can predict who will benefit from treatment",[31,111,177],"Suicide and Self-harm",[177,179,180,181,182],"Adolescents","Dialectical behavior therapy for adolescents","Routine clinical practice","Effectiveness study","2026-01-20",{"date":185,"type":37},"2026-01-22",{"date":187,"type":37},"2024-01-15",{"date":189,"type":20},"2029-12-31",{"name":191,"class":44},"Haukeland University Hospital",{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":200,"enrollmentInfo":201,"targetDuration":4,"studyType":21,"phases":203,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":216,"locationsCount":218},"100462622","phase-2-safe-treatment-for-emergency-presentation-for-suicidal-ideation-and-behavior-in-youth-100462622","NCT05304065","Safe Treatment for Emergency Presentation for Suicidal Ideation and Behavior in Youth","Youth Partners in Care for Suicide Prevention","SAFE STEPS","Inclusion Criteria:\n\n* age 13-24;\n* past-week suicidal behavior or ideation with plan or intent\n\nExclusion Criteria:\n\n* symptoms or illness that precludes informed consent or engagement in study procedures (e.g., active psychosis; drug dependence, no locator information);\n* youth not fluent in English\n* parent not fluent in English or Spanish.","24 Years",{"count":202,"type":20},1600,[204],"PHASE2","This randomized comparative effectiveness trial will compare two evidence-based approaches to emergency care for youth ages 13-24 who present to the Emergency Department (ED) with suicidal ideation or behavior. Outcomes will be monitored at baseline and at 3, 6 \\& 12 month follow-up assessments.",[61,207,27],"Suicidal",[209],"self-harm","2025-12-24",{"date":212,"type":37},"2025-12-31",{"date":214,"type":37},"2022-10-17",{"date":68,"type":20},{"name":217,"class":44},"University of California, Los Angeles",5,{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":15,"minAge":227,"maxAge":228,"enrollmentInfo":229,"targetDuration":4,"studyType":21,"phases":230,"briefSummary":232,"conditions":233,"keywords":234,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":45},"100577464","early-phase-1-psiloimagine-a-psychedelic-augmented-mental-imagery-based-intervention-for-young-people-with-self-harm-100577464","NCT06798636","PsiloIMAGINE: A Psychedelic-augmented Mental Imagery-based Intervention for Young People With Self-harm","Investigating the Effects of a Psychedelic-augmented Mental Imagery-based Intervention for Young People With Self-harm Behaviour: an Experimental Medicine Study","PsiloIMAGINE","Inclusion Criteria:\n\n* At least 2 lifetime episodes of self-harm measured using the Self-Injurious Thoughts and Behaviours Interview (Nock et al., 2007) and at least 1 self-harm episode in the past month\n* Self-harm-associated mental imagery in the past 6-weeks measured using the Self-harm Imagery Interview (Hales et al., 2011)\n* Any gender\n* Age: 16-25 years old\n* Good command of the English language\n* Mental capacity to provide written informed consent\n* Participant is willing to engage in tasks showing images of self-harm\n* Participant is willing to talk about mental health and self-harm behaviour\n* Normal ECG and blood pressure (determined by study medic)\n* Psychedelic naïve\n* No recreational drug use 7 days prior to the dosing visit\n* Comfortable using a computer and smartphone app for data collection, access to the internet from home and willing to have some of the study visits via video-link\n\nExclusion Criteria:\n\n* Current or past history of psychosis or mania in themselves or a first-degree relative\n* Current severe suicidal ideation that constitutes a risk for their participation\n* Have a medically significant condition which renders them unsuitable for the psychedelic component of the study (e.g., hypertension, diabetes, severe cardiovascular disease, hepatic or renal failure etc.)\n* Previous psychedelic use\n* Current or chronic history of kidney or liver disease\n* Have previously experienced a serious adverse response after psychedelic use\n* Intoxication on any of the visits, as assessed by difficulty in walking, the slurring of speech, difficulty concentrating or drowsiness\n* Clinically significant head injury (e.g., requiring medical or surgical intervention) that in the opinion of the investigators, contraindicates their participation\n* Severe learning disability (including dyslexia\u002Fdyspraxia) that needs support to perform daily work\u002Fschool tasks\n* Unwillingness or inability to follow the procedures outlined in the protocol\n* Are currently using a psychoactive medication\n* History of psychosurgery\n* In the opinion of the study team, they are unlikely to comply with the study protocol and lifestyle restrictions that it imposes\n* Unstable physical illness\n* Heavy smoker\n* Those needing regular specified medication that might interact adversely with psilocybin e.g., selective serotonin reuptake inhibitor, 5HT1 agonists, mirtazapine, trazodone, analgesics that have serotonergic effects (tramadol), MAOI's, antipsychotics with significant 5-HT2A receptor antagonist actions (risperidone, olanzapine, and quetiapine)\n* Those unwilling to allow their GP or involved mental health practitioners to be informed of their participation\n* Women of childbearing age who are not using reliable contraceptive methods\n* Women of childbearing age who are unable to comply with or produce a positive pregnancy urine test","16 Years","25 Years",{"count":55,"type":20},[231],"EARLY_PHASE1","Approximately 20% of young people experience self-harm behaviour in their lives. Self-harm can occur across different mental health disorders, and lead to negative outcomes and risk of suicide. Current treatments are long, costly and do not suit all young people, making it essential to research alternative treatments. Therapy combined with psychedelic drugs has recently been shown to be helpful in a variety of mental health disorders, including depression. This research project will explore the mechanisms by which combining a low dose of psychedelic psilocybin with a cognitive technique may target self-harm behaviour in young people (aged 16-25).\n\nPrevious research has shown that mental images of self-harm are common among individuals who self-harm and can increase the urge to self-harm. Imagery Re-Scripting (ImRS) is a cognitive technique that guides an individual to replace mental imagery driving self-harm with an alternative image that will instead discourage self-harm and promote alternative coping strategies. However, during ImRS individuals may fear bringing negative mental images and emotions to mind, hindering the process. Psychedelic substances can increase the ability to tolerate difficult emotions, make thinking styles more flexible and individuals more open to change. Based on this, the aim is to test if enhancing a cognitive technique with a low dose psychedelic can modify the cognitive mechanisms maintaining self- harm behaviour.\n\nThe aim is to examine the effect of a sub-hallucinogenic dose of psilocybin in combination with ImRS on cognitive processes, such as experiencing vivid mental images, and whether it can reduce these mental images and associated negative emotions in young people with recent self-harm behaviour above the effects of ImRS alone.\n\nThe hypothesis is that psilocybin could facilitate confronting the emotions that arise during ImRS and make it easier to generate new helpful mental imagery.\n\nThese experimental data could lay the foundation for future treatment development targeting self-harm in young people.",[84],[235,236,237,238],"Psilocybin","Psychedelic","Self injury","Self-Injurious Behaviour","2025-11-28",{"date":241,"type":37},"2025-12-05",{"date":243,"type":37},"2025-10-01",{"date":245,"type":20},"2026-10-31",{"name":247,"class":44},"Imperial College London",{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":15,"minAge":53,"maxAge":255,"enrollmentInfo":256,"targetDuration":4,"studyType":21,"phases":258,"briefSummary":259,"conditions":260,"keywords":266,"overallStatus":273,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":45},"100611344","culturally-adapted-dialectical-behavior-therapy-for-low-middle-income-countries-100611344","NCT07239362","CULTURALLY ADAPTED DIALECTICAL BEHAVIOR THERAPY FOR LOW-MIDDLE-INCOME COUNTRIES","Culturally Adapted Dialectical Behavior Therapy (DBT) for Mental Health in LMICs: A Randomized Controlled Trial (RCT)","Inclusion Criteria:\n\n* Adults aged 18-45 years\n* Adults who are diagnosed with or have significant traits of borderline personality disorder (BPD)\n* Adults who are willing to provide written informed consent\n\nExclusion Criteria:\n\n* Severe psychiatric comorbidity (e.g., active psychosis, substance use, etc.)\n* Acute medical conditions interfering with participation\n* Lack of basic reading and writing, or any learning disability","45 Years",{"count":257,"type":20},220,[23],"The study aims to assess the efficacy of culturally adapted dialectical behaviour therapy (DBT) for addressing emotional dysregulation in a low- and middle-income country, as well as to evaluate the impact of DBT on secondary outcomes such as borderline personality traits, self-harm or suicide, depression, anxiety, and individuals' functioning and disability.\n\nThrough a rigorous Randomised Controlled Trial (RCT), the research seeks to assess how cultural adaptations of dialectical behaviour therapy improve its applicability, engagement, and outcomes in diverse socio-cultural settings, contributing to more accessible and effective mental health interventions in resource-limited regions.",[261,262,263,84,264,265],"Borderline Personality Disorder (BPD)","Dialectical Behavior Therapy","Emotional Dysregulation","Suicidal and Self-injurious Behavior","Depression Anxiety Disorder",[267,268,269,61,270,271,272],"BPD","DBT","Self harm","Borderline personality","Dialectical behavior therapy","Emotional dysregulation","NOT_YET_RECRUITING","2025-11-22",{"date":239,"type":37},{"date":277,"type":20},"2025-11-20",{"date":279,"type":20},"2026-07-31",{"name":281,"class":44},"Pakistan Association of Cognitive Therapists",{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":15,"minAge":227,"maxAge":289,"enrollmentInfo":290,"targetDuration":4,"studyType":21,"phases":292,"briefSummary":293,"conditions":294,"keywords":295,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":45},"100570262","augmented-momentary-personal-ecological-risk-evaluation-100570262","NCT06704958","Augmented Momentary Personal Ecological Risk Evaluation","AMPERE","Inclusion Criteria:\n\n* Young adults (age 16-30 years)\n* Receiving care at University of Washington Primary Care for suicidal ideation as determined by Electronic Health Record problem list or PHQ-9 suicide risk item \\>0 in previous year and\u002For recent (past year) history of suicide attempt and\u002For active suicidal ideation.\n* Ability to consent to participate\n\nExclusion Criteria:\n\n* Age \\\u003C16 or \\>30,\n* Non-English speaking\n* No smart phone access\n* Any clinical medical\u002Fpsychiatric condition, severity of that condition, or life situation that would compromise safe and voluntary study participation.","30 Years",{"count":291,"type":20},50,[23],"The goal of this intervention study is to co-design and test an Ecological Momentary Assessment (EMA) prototype tool with young adults aged 16-30 experiencing suicidality to see if it is an acceptable and usable clinical tool for risk management.\n\nThe main study aims are:\n\n* To co-design a prototype EMA suicide risk monitoring system with patients and health care provider input using Human Centered Design (HCD) methods.\n* To test the developed EMA protype with providers and their young adult patients aged 16-30 experiencing suicidality to determine if the EMA prototype is an acceptable and usable clinical tool.\n\nYoung adult participants receiving care for active suicidal ideation will\n\n* Download and use the EMA prototype for a total of two months.\n* Complete 3 online surveys at 0, 1 and 2 months after enrolled in the study.",[111,84],[296,86],"suicidal ideation",{"date":298,"type":37},"2025-11-26",{"date":300,"type":37},"2025-09-25",{"date":302,"type":20},"2026-07-01",{"name":304,"class":44},"University of Washington",{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":15,"minAge":53,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":21,"phases":314,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":329},"100569860","impact-of-mindful-self-compassion-therapy-on-self-harm-behaviors-emotional-regulation-and-quality-of-life-among-patients-with-borderline-personality-disorder-100569860","NCT06699732","Impact of Mindful Self-Compassion Therapy on Self Harm Behaviors, Emotional Regulation and Quality of Life Among Patients With Borderline Personality Disorder","Impact of Mindful Self-Compassion Therapy on Self Harm Behaviors, Emotional Regulation and Quality of Life Among Patients With Borderline Personality Disorder: A Randomized Controlled Trial","Inclusion Criteria:\n\n* 1\\. First time diagnosed non-hospitalized patients of Borderline Personality Disorder.\n\n  2\\. Patients of Borderline Personality Disorder experiencing psychological distress,low level of quality of life, social support, emotional dysregulation would be included.\n\n  3\\. Borderline Personality Disorder patients with age 18 years and above (both gender) from outpatient department (OPD) 4. Borderline personality patients who would be able to understand Urdu language and can give the informed consent\n* Exclusion criteria\n\nThe study would have the following exclusion criteria:\n\n1. Hospitalized patients of Borderline Personality\n2. Patients with Borderline Personality having other chronic co-morbid diseases such as cancer, cognitive deficits, and other chronic psychological disorders.\n3. Patients with Borderline Personality younger than 18 years of age",{"count":313,"type":20},60,[23],"The primary purpose of the study is to investigate whether Mindful Self-Compassion (MSC) therapy can significantly reduce self-harm behaviors, improve emotional regulation, and enhance the quality of life in individuals diagnosed with Borderline Personality Disorder (BPD). The study aims to contribute to the existing literature by providing robust evidence on the efficacy of MSC therapy for BPD, which could inform clinical practices and improve treatment outcomes",[317,318,84,319,261],"Psychological Distress","Emotional Regulation","Quality of Life (QOL)","2025-08-29",{"date":322,"type":37},"2025-09-02",{"date":324,"type":37},"2024-09-21",{"date":326,"type":20},"2025-12-30",{"name":328,"class":44},"Fatima Jinnah Women University",2,{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":11,"sex":15,"minAge":53,"maxAge":336,"enrollmentInfo":337,"targetDuration":339,"studyType":56,"phases":4,"briefSummary":340,"conditions":341,"keywords":347,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":357,"locationsCount":358},"100547361","brief-admission-by-self-referral-for-individuals-with-self-harm-effects-on-compulsory-care-100547361","NCT06406972","Brief Admission by Self-referral for Individuals With Self-harm: Effects on Compulsory Care","Inclusion Criteria:\n\n* Living in the uptake area of Lund, Linköping, Helsingborg or Norrköping\n* Age 18-65 years at the time of inclusion\n* Admitted to hospital either diagnosed with ICD-10 diagnosis BPD F60.3, or admitted at least twice with Intentional self-harm X60-83 in combination with one of more of the following diagnoses ADHD (F90.0-F90.X), Bipolar disorder type 2, (F31.8W, F318A-F, F31.0, F31.8-9, F31.8W) or Autism, Atypical autism, Aspergers syndrome (F84.0, F84.1, F84.5) or Mild intellectual disability (F70.0-F70.9).\n\nExclusion Criteria:\n\n* not fulfilling inclusion criteria","65 Years",{"count":338,"type":20},7000,"5 Years","Brief Admission by self-referral (BA) is a standardized treatment model, providing patient-controlled and person-centered care. It was developed to reduce self-harm and compulsory care by promoting autonomy. Randomized clinical trials have not yielded significant between group differences with respect to inpatient care, including compulsory care. The major difficulty in evaluating BA is preventing the control group from cross-contamination, as in the implementation process of BA, all physicians, all inpatient and outpatient staff as well as managers need to be informed and undergo basic education regarding the intervention. As BA addresses a prevalent and frustrating issue in psychiatric health care, there is considerable risk that the approach leaks to the control group, reducing the possibility to detect between-group differences. In the current study this will be addressed through a register-based approach, comparing similar clinics, implementing BA at different timepoints over time. Individuals with traits of borderline personality disorder will be included and comparisons will be made with respect to compulsory care, voluntary inpatient care and mortality.",[342,61,343,31,344,345,346],"Self-injury","Suicide, Attempted","Borderline Personality Disorder","Emergency Psychiatric","Hospitalizations Psychiatric",[348,209,349,350],"Brief Admission by self-referral","traits of borderline personality disorder","compulsory care","2025-08-10",{"date":353,"type":37},"2025-08-14",{"date":355,"type":37},"2010-09-15",{"date":212,"type":20},{"name":70,"class":44},4,{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":15,"minAge":53,"maxAge":4,"enrollmentInfo":365,"targetDuration":367,"studyType":56,"phases":4,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":45},"100548708","effects-of-psychiatric-admissions-on-self-harm-and-suicide-in-people-with-borderline-personality-disorder-100548708","NCT06424509","Effects of Psychiatric Admissions on Self-harm and Suicide in People With Borderline Personality Disorder","Inclusion Criteria:\n\n* Psychiatric clinic in Sweden authorized to administer compulsory care for adults. Each clinic per specific calendar year will represent one participant, identified by the clinic's name and the respective year (e.g., Umeå2010, Linköping2013, Malmö2022).\n\nExclusion Criteria:\n\n* No authorization to administer compulsory care for adults",{"count":366,"type":20},390,"1 Year","The current study aims to evaluate the impact of long (\\>5 days) and\u002For compulsory psychiatric inpatient care on subsequent healthcare utilization for self-harm and suicide in people with borderline personality disorder, a condition characterized by frequent self-harm.\n\nThe basis for this study is the diversity of clinical practices across Swedish regions. By categorizing clinics based on their practices with respect to long and\u002For compulsory psychiatric inpatient care, it is possible to explore the impact of these practices on subsequent somatic and psychiatric healthcare, including emergency care due to self-harm as well as on completed suicides.\n\nAll psychiatric clinics across Sweden authorized to administer compulsory care for adults, totalling 78 clinics will be included. Each clinic per specific calendar year will represent one participant, identified by the clinic's name and the respective year (e.g., Umeå2010, Linköping2013, Malmö2022).\n\nData collection will involve the utilization of the national registers to capture outcome measures and account for confounding factors. The participants will be ranked based on a composite variable, which includes the average number of days spent in inpatient compulsory care and other psychiatric inpatient care exceeding 5 days, among individuals diagnosed with BPD. The top quartile of participants will be compared with the bottom quartile.",[344,31,370,61],"Non-suicidal Self-injury","2025-08-06",{"date":373,"type":37},"2025-08-12",{"date":375,"type":37},"2010-01-01",{"date":377,"type":20},"2027-01-01",{"name":379,"class":44},"Lund University",{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":387,"sex":15,"minAge":388,"maxAge":227,"enrollmentInfo":389,"targetDuration":4,"studyType":21,"phases":391,"briefSummary":392,"conditions":393,"keywords":397,"overallStatus":273,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":4},"100592640","effects-of-a-multifaceted-school-based-intervention-to-protect-mental-health-and-prevent-suicidal-behaviour-in-adolescents-in-spain-100592640","NCT06996054","Effects of a Multifaceted School-Based Intervention to Protect Mental Health and Prevent Suicidal Behaviour in Adolescents in Spain","DEVELOPMENT AND EVALUATION OF A MULTIFACETED SCHOOL-BASED INTERVENTION TO PROTECT MENTAL HEALTH AND PREVENT SUICIDAL BEHAVIOR AMONG ADOLESCENTS IN SPAIN","Inclusion Criteria:\n\n* Students enrolled in the 2nd or 3rd year of compulsory secondary education during the 2026-2027 academic year in the Balearic Islands, Spain.\n* Aged between 12 and 16 years at the time of recruitment.\n* Provision of written informed consent from both the student and at least one parent\u002Flegal guardian.\n* Attending school centres with a student population composed of no more than 75% of a single gender.\n* Enrollment in a participating classroom randomly selected for the study.\n\nExclusion Criteria:\n\n* Presence of cognitive, developmental, or language impairments that, in the judgment of school staff or study personnel, would prevent the student from understanding the intervention content or completing the study assessments reliably.\n* Students currently receiving intensive psychological or psychiatric treatment for acute suicidality or severe mental health conditions that require individualized clinical management beyond the scope of a school-based programme.\n* Students or parents who explicitly decline participation in specific intervention components, such as group discussions on suicide or mental health.\n* Participation in a concurrent school-based mental health programme that could confound the effects of the intervention.",true,"12 Years",{"count":390,"type":20},2280,[23],"What is this study about? This study aims to find out if a school-based program can help improve mental health and prevent suicidal thoughts and behaviors in teenagers in Spain. Suicide is one of the leading causes of death among young people. Many teens who think about or attempt suicide are also struggling with mental health problems like depression. Schools offer a unique opportunity to help because almost all adolescents attend school regularly.\n\nWhat will happen in the study?\n\nThe study will include about 2,280 students aged 12 to 16 years from 38 secondary schools in the Balearic Islands, Spain. Schools will be randomly assigned to one of two groups:\n\nIntervention group: Students will participate in four weekly classroom sessions led by trained psychologists. These sessions will help students learn about mental health, manage their emotions, recognize signs of distress in themselves or others, and ask for help when needed. At the same time, parents and teachers will follow a digital training program with videos and resources to help them support students' mental health and recognize warning signs.\n\nControl group: Students will receive a minimal intervention, which includes educational posters displayed in classrooms.\n\nWhat is the purpose of this program? The main goal is to reduce suicidal thoughts and behaviors. The program also aims to improve students' overall mental well-being, reduce depression symptoms, and encourage help-seeking behaviors. It also helps parents and teachers feel more confident in supporting teens who may be at risk.\n\nHow will the study be evaluated? Students will complete questionnaires at the start of the study and again after six months. These surveys will ask about mental health, suicidal thoughts, emotional well-being, self-harm, substance use, and experiences with bullying. Parents and teachers will also complete surveys about their knowledge and confidence in supporting students.\n\nWhy is this study important? There is an urgent need to find effective ways to prevent suicide and support young people's mental health. This program involves students, families, and schools in working together to create a safe and supportive environment. If the program works, it could be used in schools throughout Spain and possibly in other countries too.\n\nWho is funding this study? The study is funded by Fundación Mutua Madrileña.",[112,394,395,27,396],"Depression","Adolescent Mental Health","Suicidal Ideation and Behavior",[398,119,399,400,394,179,401,402,403,404,405,406,407,408,409,410,31],"School-based intervention","Suicidal ideation","Suicidal behavior","Mental health promotion","Psychoeducation","Gatekeeper training","Teachers","Parents","Digital health","Cluster randomized controlled trial","Spain","Secondary education","Emotional regulation","2025-05-21",{"date":413,"type":37},"2025-05-30",{"date":415,"type":20},"2025-10",{"date":417,"type":20},"2027-06",{"name":419,"class":420},"Fundació d'investigació Sanitària de les Illes Balears","OTHER_GOV",{"id":422,"slug":423,"hasResults":11,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":387,"sex":15,"minAge":16,"maxAge":428,"enrollmentInfo":429,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":431,"conditions":432,"keywords":433,"overallStatus":273,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":446,"leadSponsor":448,"locationsCount":4},"100590344","co-producing-lgbtq-affirmative-dbt-protocols-100590344","NCT06966193","Co-Producing LGBTQ-Affirmative DBT Protocols.","Co-Producing LGBTQ-Affirmative Intervention Protocols for LGBTQ+ People at Risk of Self-Harm and Suicide: A Co-Production Study","DBT Cohort Young Person Sample 1\n\nInclusion criteria will include that the young person:\n\n1. Is aged 13 to 21 years old;\n2. has completed at least four months of comprehensive DBT (i.e. inclusive of all four modes of intervention; Linehan, 1993; Miller et al., 2006; Rathus \\& Miller, 2015) in the past 24 months or have completed at least four months of DBT and are still in a comprehensive DBT programme;\n3. identifies as LGBTQ+ (including those questioning or unsure about their orientation\u002Fidentity);\n4. is willing and able to participate in the study. While no specific inclusion or exclusion criteria will be placed on other variables, typically to be eligible for a DBT programme, young people would need to have a history of self-harm and\u002For suicidal behaviours, difficulties with emotion regulation, and potentially difficulties with the remaining symptom list within borderline\u002Femotionally unstable personality disorder. Recruitment size is based on PPI recommendations regarding effective group sizes, with allowances for sample attrition.\n\nNon-DBT Cohort Young Person Sample 2\n\nInclusion criteria will follow similar to sample 1. The young person:\n\n1. Is aged 13 to 21 years old;\n2. has not accessed and is not currently enrolled in a comprehensive DBT programme;\n3. has experienced difficulties with LGBTQ-related identity confusion, managing stigma experiences, and connecting with similar others;\n4. identifies as LGBTQ+ (including those questioning or unsure about their orientation\u002Fidentity);\n5. is willing and able to participate in the study (i.e. are based in the UK and can attend the in-person and online groups).\n\nNo other inclusion or exclusion criteria will be systematically implemented for this group.\n\nDBT Therapist Sample\n\nInclusion criteria:\n\n1. Currently practicing or having completed (or recently finished, within the past 12 months) a comprehensive DBT programme as a DBT therapist. In order to practice as a DBT therapist, they must hold a professional qualification recognised by appropriate healthcare regulators.\n2. Having experience working with at least one LGBTQ+ client in DBT, who was aged between 13 and 21 years at the time.\n3. Being willing and able to participate in the study.","21 Years",{"count":430,"type":20},32,"Aims:\n\n1. To co-produce new intervention parts that meet the needs of LGBTQ+ people at risk of self-harm or suicidal thoughts, with LGBTQ+ people and DBT therapists. These intervention parts will be integrated into a Dialectical Behaviour Therapy (DBT) intervention, that is provided earlier in a persons mental health care journey, than DBT is usually targeted at.\n2. To assess how acceptable and feasible the co-production process was for participants, and how well it achieved co-production principles (e.g. participants feel supported, that the aims were transparent, etc).\n\nWhy is This Important? Young people who identify as lesbian, gay, bisexual, transgender, queer, and with other minoritised gender and sexual identities (LGBTQ+) are much more likely to self-harm and experience suicidal thoughts than cisgender-heterosexual (non-LGBTQ+) people. They also experience barriers when accessing mental health support. Some of these barriers come from a lack of support tailored towards their needs as an LGBTQ+ person. This often means that things get worse before they access the right support, and so are often seen in higher-intensity interventions (tier 4 or tertiary care), like DBT.\n\nWhat The Investigators Plan to Do:\n\nThe investigators plan to hold some focus groups with three different groups of people to co-produce the new intervention parts. The three groups include:\n\n1. A group of LGBTQ+ young people (13-21 years old) who have completed a at full DBT programme recently.\n2. A group of LGBTQ+ young people (13-21 years old) who have never been in a full DBT programme but experienced similar difficulties.\n3. A group of DBT therapists who have supported LGBTQ+ young people before.\n\nThe investigators will seek feedback from participants about how acceptable they found the study (e.g. how satisfied they were with the process), how feasible it was (e.g. were they able to attend and was it practice?), and how well they stuck to the coproduction principles (e.g. how supported they felt).",[27,207,263],[434,268,27,435,436,437,438,439,440,179,441],"LGBTQ+","Suicidal Behaviours","Emotion Dysregulation","Young People","Sexual Minorities","Gender Minorities","Co-Production","Therapists","2025-05-12",{"date":444,"type":37},"2025-05-15",{"date":243,"type":20},{"date":447,"type":20},"2026-07-30",{"name":449,"class":44},"King's College London",{"id":451,"slug":452,"hasResults":11,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":387,"sex":15,"minAge":16,"maxAge":53,"enrollmentInfo":458,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":460,"conditions":461,"keywords":467,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":482,"locationsCount":329},"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).",{"count":459,"type":20},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.",[31,462,463,464,465,466],"Personality Disorder, Borderline","Epigenetic Disorder","Non-Suicidal Self Injury","Change; Mental","Difference, Individual",[87,468,469,470,471,472,473,474,475],"deliberate self-harm","risk and protective factors","suicidal behavior","non-suicidal self-injury","risk assessment","attachment","genetics","epigenetics","2025-03-26",{"date":478,"type":37},"2025-03-28",{"date":480,"type":37},"2023-03-23",{"date":415,"type":20},{"name":483,"class":44},"University of Ljubljana, Faculty of Medicine",{"id":485,"slug":486,"hasResults":11,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":490,"eligibilityCriteria":491,"healthyVolunteers":387,"sex":15,"minAge":53,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":494,"conditions":495,"keywords":498,"overallStatus":273,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":4},"100584923","self-harm-and-the-prison-environment-mixed-methods-study-100584923","NCT06895668","Self-harm and the Prison Environment Mixed Methods Study","Self-harm and the Prison Environment (SHAPE): a Mixed Methods Study of the Role of Custody-specific Factors in Self-harm Behaviours Amongst Men and Women in Prison.","SHAPE","Inclusion Criteria:\n\n\\- New entrants to prison\n\nExclusion Criteria:\n\n* Expected release\u002Ftransfer date less than 12 weeks from date of entry\n* Lack capacity to give informed consent\n* Insufficient spoken English skills to participate\n* Assessed persistently as not safe to be seen face to face due to imminent high risk of violence.\n* Risk of psychological harm from participation more than minimal (based on risk assessment with prison's Safer Custody and mental health teams)",{"count":493,"type":20},458,"Self-harming behaviour is a major problem in UK prisons: the number of self-harm incidents has more than doubled over the past decade. People who self-harm in prison are at greater risk of subsequent death by suicide. Risk assessment processes for the prison population are rudimentary and critically under-informed. Research evidence shows that a person's life history and current mental health make some more vulnerable than others to such behaviour. However, the role of the prison environment in contributing to self-harm risk is poorly understood. A wide range of environmental factors might be important, such as the degree of contact with the outside world, stimulation in the daily regime and conflicts with peers and prison staff. In a pilot study that the investigators carried out in a male prison, prison environment characteristics such as placement in a single-occupancy cell and changing cell or cellmate more frequently were associated with self-harm. These environmental factors now require further study in larger-scale research in men and women's prisons. Understanding which environmental factors are relevant to self-harming behaviour will help prison and healthcare staff to make better informed assessments of self-harming risks and better management plans to reduce such behaviours.\n\nThis study aims to establish the impact of the prison environment on self-harming behaviour amongst both men and women in prison using a mixed methods approach. The investigators now want to establish the precise influence of such factors in both male and female prisoners to help to improve the management of such behaviour. This will be done by interviewing and following up groups of male and female prisoners for a 12 week period (the cohort study). The investigators will then use focus groups to explore prisoner, staff and other stakeholder views on the findings (the focus group study). Finally, female self-harming prisoners will be interviewed to explore the detailed perspectives of women (the interview study). The studies will take place at three prisons: HMP Wandsworth and HMP Pentonville (both medium security men's prisons) and HMP Bronzefield (a high security women's prison).\n\nCohort study: Adults entering either prison are eligible to participate. The investigators will recruit a random sample of 458 men and women (based on a power calculation informed by previous pilot work). Participants will complete two 1-hour baseline assessments before being followed up for 12 weeks. The researchers will conduct two further in-person assessments and examine the participant's health and custodial records at the prison and link this with local wing-level prison data. The results will establish which of a range of possible prison environmental factors are related to self-harming behaviour.\n\nThe following prison-related predictors of self-harm behaviour will be examined in the cohort study:\n\n* Placement in a single-occupancy cell\n* Frequency of cell changes\n* Placement in solitary confinement\n* Violence perpetration\n* Other disciplinary infractions\n* Violent\u002Fsexual victimisation\n* Work status in prison\n* Time in purposeful activities\n* Social visit status\n* Legal status\n* Time out of cell (cumulative exposure)\n* Staffing ratio (cumulative exposure)\n* Staff experience (cumulative exposure)\n* Staff responsivity to emergency bells (cumulative exposure)\n\nFocus group study: The researchers will then use focus groups to explore the perspectives of prisoners and staff on our research findings and their implications for day-to-day practice. Adult self-harming prisoners, peer support workers, supervising officers and healthcare staff at the same prisons, alongside other stakeholders working in the field - including carers - will be eligible to participate in audio-recorded focus groups.\n\nInterview study: The investigators will explore in more detail the impact of prison-related factors on self-harm behaviour amongst female prisoners (having already completed such interviews with male prisoners in our pilot work). 10 adult self-harming women at HMP Bronzefield will be recruited to take part in audio-recorded semi-structured interviews.\n\nAnswering these questions will help to inform prison-wide strategies for reducing self-harm in both male and female prisoners.",[27,496,497],"Self-harm Behavior","Self-Harm, Deliberate",[31,342,499,500,501,502,503,504,505,506,507,508],"Prospective cohort study","Qualitative","Focus groups","Semi-structured interviews","Environmental factors","Prison","Custody","Offenders","Prisoners","Incarceration","2025-03-25",{"date":476,"type":37},{"date":512,"type":20},"2025-07-01",{"date":514,"type":20},"2027-03-31",{"name":449,"class":44},{"id":517,"slug":518,"hasResults":11,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":11,"sex":15,"minAge":388,"maxAge":523,"enrollmentInfo":524,"targetDuration":4,"studyType":21,"phases":526,"briefSummary":527,"conditions":528,"keywords":529,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":539,"locationsCount":218},"100386989","predictors-of-clinical-course-and-treatment-response-in-dbt-programmes-100386989","NCT04318899","Predictors of Clinical Course and Treatment Response in DBT Programmes","Predictors of Clinical Course and Treatment Response in Patients Having Received Dialectical Behaviour Therapy Delivered by Clinical Units in the Norwegian Network for Clinical Evaluation and Quality in DBT Programmes","Inclusion Criteria:\n\n* History of repeated deliberate self harm\n* Satisfies criteria of Diagnostic and Statistical Manual (DSM-IV) Borderline Personality Disorder as measured by Structured Clinical Interview for the DSM (SCID-II) in addition to the self-destructive criterion.\n\nExclusion Criteria:\n\n* Psychotic disorders\n* Anorexia Nervosa\n* Substance dependence disorder\n* Mental retardation (IQ less than 70)\n* Asperger syndrome\u002Fautism","70 Years",{"count":525,"type":20},250,[23],"The project is a collaboration between The National Centre for Suicide Research and Prevention (NSSF) and clinical units with Dialectical Behaviour Therapy (DBT) programmes. A methodological and technological platform has been established that enables clinicians to deliver high quality treatments over extended periods of time, to evaluate their own performance and productivity and to report it in a uniform and systematic way that will enable comparison across clinical settings and programmes. The collected data constitute the basis for conducting the clinical study with the overall aim to study predictors of the clinical course and treatment response in patients admitted to DBT programmes in Norway.",[84,344],[86,530,531,532],"dialectical behaviour therapy","borderline personality disorder","emotional dysregulation","2025-03-18",{"date":535,"type":37},"2025-03-21",{"date":537,"type":37},"2018-01-01",{"date":212,"type":20},{"name":540,"class":44},"Oslo University Hospital",{"id":542,"slug":543,"hasResults":11,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":4,"eligibilityCriteria":547,"healthyVolunteers":387,"sex":15,"minAge":53,"maxAge":336,"enrollmentInfo":548,"targetDuration":4,"studyType":21,"phases":549,"briefSummary":550,"conditions":551,"keywords":553,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":45},"100350712","emotional-dysregulation-in-para-suicidal-behavior-100350712","NCT03846375","Emotional Dysregulation in Para-suicidal Behavior","Emotional Dysregulation in Para-suicidal Behavior: Effects of Dialectical Behavioral Therapy on Emotional Processing, a Triangulation Approach","Inclusion Criteria Patients:\n\n* Patients with non-suicidal self-injury and\u002For suicidal ideation that undergo standard clinical outpatient DBT treatment will be recruited.\n\nExclusion Criteria Patients:\n\n* Lack of informed consent\n\nExclusion Criteria Healthy Controls:\n\n* Lack of informed consent\n* former or current neurological conditions\n* severe psychiatric illness\n* cardiac conditions.",{"count":313,"type":20},[23],"This is a naturalistic cohort pre-post study investigating aspects of emotional processing and how possible changes in emotional processing is related to the successful treatment of non-suicidal self-injury and suicidal ideation in a program of Dialectical Behavior Therapy. In addition we wish to identify to what extent the intensity and frequency of non-suicidal self-injury and suicidal ideation is related to difficulty in emotion regulation, as indicated by self-report measures and psychophysiological measures.",[84,343,552,344],"Emotional Instability",[263,410,554,555],"Dialectical Behavioral Therapy","para-suicidal behavior","2019-08-26",{"date":558,"type":37},"2019-08-28",{"date":560,"type":37},"2019-01-15",{"date":562,"type":20},"2028-01-02",{"name":191,"class":44}]