[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mental-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mental-disorders":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,50,95,126,148,179,211,237,274,298,330,364,397,427,464,492,539,566,593,630,663,688,710,741,768],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100504886","stimulation-induced-changes-in-fronto-limbic-network-100504886",false,"NCT05854160","Stimulation-Induced Changes in Fronto-Limbic Network","Stimulation-Induced Changes in Fronto-Limbic Connectivity Control Regulation of the Emotional Response to Threat","Stim_Con","Inclusion Criteria:\n\n* 1\\) implantation of sEEG electrodes for SOC epilepsy surgery evaluation\n* 2\\) cognitive ability to perform simple tasks and to understand instructions\n* 3\\) implanted electrodes in the amygdala and medial PFC regions\n* 4\\) competency to understand and sign a written informed consent.\n\nExclusion Criteria:\n\n* 1\\) an inability to complete the task","ALL","18 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"NA","The purpose of this research is to better understand how emotion processing unfolds in the brain using stereoelectroencephalography (sEEG) and direct brain stimulation. This study will use standard behavioral emotion processing tasks combined with neural recording and direct brain stimulation to assess different aspects of emotion processing. Stimulation pulses during pre and post-test periods will assess the effects of stimulation before and after conditioning, the results of which will be combined with results from the activity of each electrode during the emotion tasks to inform us of the nature of emotion processing in the brain and allow us to devise brain modulation protocols in the future.",[28,29],"Epilepsy","Mental Disorders",[31,32,33,34,35,36],"epilepsy","comorbid mental health disorders","sEEG","Anxiety","Fronto-limbic network","Pavlovian fear conditioning paradigm","RECRUITING","2026-06-18",{"date":40,"type":41},"2026-06-23","ACTUAL",{"date":43,"type":41},"2023-03-01",{"date":45,"type":22},"2027-02-24",{"name":47,"class":48},"University of Alabama at Birmingham","OTHER",1,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":76,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":49},"100555424","phase-2-investigation-of-the-antidepressant-effects-of-2r6r-hnk-an-enhancer-of-synaptic-glutamate-release-in-treatment-resistant-depression-100555424","NCT06511908","Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression","An Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Ability of participant to understand and willingness to sign a written informed consent document. To verify this, participants must score \\>= 80% on the consent quiz.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. 18 to 70 years of age.\n4. All participants must have undergone a screening assessment under protocol 01-M-0254.\n5. Participants must fulfill DSM-IV or DSM-5 criteria for MDD, single episode or recurrent without psychotic features, based on clinical assessment and confirmed by a structured diagnostic interview (SCID-P). Participants must be experiencing a current major depressive episode lasting at least two weeks.\n6. Participants must have an initial score of \\>= 20 on the MADRS and a YMRS score of \\\u003C12 within one week of study entry and upon entry into Phase II.\n7. Ability to take intravenous medication and be willing to adhere to the (2R,6R)-HNK regimen.\n8. Participants must have a current or past history of lack of response to at least one adequate antidepressant trial (may be from the same chemical class), with at least one in the current major depressive episode, operationally defined using the modified Antidepressant Treatment History Form (ATHF); non-response to an adequate trial of ECT or TMS would count as an adequate antidepressant trial.\n9. For individuals of reproductive potential: use of highly effective contraception starting at the time of enrollment and agreement to use such a method during study participation and for an additional four weeks after the end of Study Phase II.\n10. For males of reproductive potential: use of condoms or other methods from the time of enrollment to ensure effective contraception with partner, and for an additional 90 days after the end of Phase II.\n11. Agreement to adhere to Lifestyle Considerations throughout study duration.\n12. Medically healthy, or with stable, treated, chronic medical conditions (provided any medications are not excluded)\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Current use of disallowed concomitant medications or transcranial magnetic stimulation (TMS) two weeks prior to the start of Phase II.\n2. Treatment with a reversible monoamine oxidase inhibitor (MAOI) four weeks prior to the start of Phase II.\n3. Treatment with fluoxetine, aripiprazole, or brexpiprazole five weeks prior to the start of Phase II.\n4. Treatment with clozapine or electroconvulsive therapy (ECT) four weeks prior to the start of Phase II.\n5. Ongoing treatment with moderate or strong CYP3A4\u002F5 inhibitors or inducers\n6. Lifetime history of deep brain stimulation.\n7. Previous antidepressant non-response to ketamine or esketamine (full course).\n8. No structured psychotherapy will be permitted during the total duration of the study. Participants unable or unwilling to stop psychotherapy will be unable to participate in the study.\n9. Pregnancy or lactation.\n10. Current psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-5.\n11. Participants with a history of DSM-IV substance or alcohol abuse or dependence, or DSM-5 substance use disorder (except for caffeine, nicotine, or cannabis), or moderate to severe alcohol use disorder, within the preceding three months. In addition, participants who are currently using drugs (except for caffeine, nicotine, or cannabis) must not have used illicit substances or known drugs of abuse in the two weeks prior to screen and must have a negative drug urine test (except for prescribed benzodiazepines or stimulants) prior to starting Phase II. Cannabis use is exclusionary if the use is daily, or if participants are unable to abstain during the study, or if function of daily life is impaired by use as determined by a clinician. Due to the interactions between cannabis and SSRIs, frequent cannabis use during previous antidepressant treatment will result in that treatment being considered a failed trial for eligibility purposes.\n12. Participants with a DSM-IV or DSM-5 Axis II diagnosis of borderline or antisocial personality disorder.\n13. Participants with a history of head injury that resulted in loss of consciousness exceeding five minutes (for the imaging component of the study).\n14. No serious, unstable medical illnesses including but not limited to the following body systems and organs or those that in the judgment of the Principal Investigator pose a risk to the participant's ability to safely participate in the study: Hepatic diseases (e.g. active viral hepatitis infection or cirrhosis of the liver, any liver disease with Child-Pugh score \\>=5), cardiovascular disease (including ischemic heart disease, coronary artery disease, congestive heart failure, poorly controlled hypertension due to risk of further blood pressure elevation and increase in demand on cardiac function from study drug), renal\u002Furologic (e.g chronic kidney disease or acute kidney injury, history of bladder dysfunction due to theoretical risk of ketamine-induced cystitis, moderate to severe renal impairment of any etiology), endocrinologic (including uncontrolled diabetes due to association with progressive abnormality of the microvasculature and nervous system), or neurologic disease (e.g. elevated intraocular pressure or history of or presence of diseases that are associated with elevated intracranial pressure).\n15. Participants with unstable clinical hyperthyroidism or hypothyroidism.\n16. Participants with one or more seizures without a clear and resolved etiology.\n17. Clinically significant abnormal laboratory tests specifically defined by:\n\n    * Alkaline phosphatase (Alk Phos) \\> 150 U\u002FL\n    * Alanine aminotransferase (ALT) \\> 55 U\u002FL\n    * Aspartate aminotransferase (AST) \\> 34 U\u002FL\n    * Total bilirubin (TB) \\> 1.2 mg\u002FdL\n    * Direct bilirubin (DB) \\> 0.5 mg\u002FdL\n    * 25-hydroxyvitamin D \\\u003C 20 ng\u002FmL\n    * Folate \\\u003C 2ng\u002FmL\n    * Vitamin B12 \\\u003C 200 pg\u002FmL\n18. Moderate to severe renal impairment with body surface area corrected eGFR \\\u003C60mL\u002Fmin.\n19. Participants who, in the Principal Investigator's judgment, pose a current serious suicidal or homicidal risk.\n20. Positive HIV test.\n21. Contraindications to MRS (metal in body, claustrophobia, etc. for imaging)\n22. Participants with COVID-19 or suspected COVID-19\n23. Inability to read and understand English. Non- English speakers will not be eligible as most of the required monitoring and rating instruments are not validated in languages other than English.","70 Years",{"count":59,"type":22},50,[61],"PHASE2","Background:\n\nMajor depressive disorder (MDD) is a serious mental illness that can put people at risk of self-harm and death. Many drugs are used to treat MDD, but it can take a long time for them to be effective. Researchers want to know if a faster-acting drug, (2R,6R)-hydroxynorketamine (HNK), can better treat the symptoms of MDD.\n\nObjective:\n\nTo test a study drug (HNK) in people with MDD.\n\nEligibility:\n\nPeople aged 18 to 70 years with MDD. They must have had a screening assessment under protocol 01-M-0254.\n\nDesign:\n\nParticipants will be tapered off their current MDD drugs over 2 to 5 weeks. They will stay off of the drugs for up to 2 weeks prior to starting the study medication and procedures. They will have a physical exam with blood tests. They will have tests of their heart function, mood, and thinking. They will answer questions about their symptoms. They may choose to have imaging scans and scans of their brain activity.\n\nHNK is given through a tube attached to a needle inserted into a vein. Participants will receive infusions on this schedule:\n\nThey will receive 4 infusions over 2 weeks. They will stay in the clinical center overnight after each infusion or for the duration of the study.\n\nThey will receive no drugs for 2 to 3 weeks.\n\nThey will have 4 more infusions over 2 weeks, with overnight stays after each or for the duration of the study.\n\nOne set of 4 infusions will be the HNK. The other set of 4 infusions will be a placebo. A placebo looks just like the real drug but contains no medicine. Participants will not know when they are getting the HNK or placebo.\n\n...",[64,65,66,67,68,69,70,71,72,73,29,74,75],"Suicide","Depressive Disorder, Treatment-Resistant","Ketamine","Molecular Mechanisms of Pharmacological Action","Neurotransmitter Agents","Excitatory Amino Acid Agents","Physiological Effects of Drugs","Depressive Disorder, Major","Depressive Disorder","Depression","Mood Disorders","Behavioral Symptoms",[77,66,78,79,80,81,82,83,84],"Major Depressive Disorder","Biomarkers","Neuropharmacology","Magnetic Resonance Imaging","Magnetoencephalography","Neurobiology","Glutamate","Hydroxynorketamine","2026-06-13",{"date":87,"type":41},"2026-06-16",{"date":89,"type":41},"2024-11-06",{"date":91,"type":22},"2027-07-01",{"name":93,"class":94},"National Institute of Mental Health (NIMH)","NIH",{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":23,"phases":105,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":49},"100641660","the-green-room-virtual-nature-for-mental-well-being-in-the-acute-psychiatry-ward-100641660","NCT07655063","The Green Room: Virtual Nature for Mental Well-being in the Acute Psychiatry Ward","The Green Room: A Mixed-Methods Randomized Controlled Trial Evaluating Virtual Reality-Based Nature Exposure in an Acute Psychiatry Ward","GREEN ROOM","Inclusion Criteria:\n\nAdults aged 18 to 65 years. Admitted to the Acute Psychiatry Ward (regardless of voluntary or involuntary legal status).\n\nSufficient cognitive and clinical stability to provide informed consent and engage with the VR equipment, as determined by the clinical team.\n\nAbility to communicate effectively in Spanish.\n\nExclusion Criteria:\n\nHistory of photosensitive epilepsy or severe seizure disorders. Presence of active facial injuries, infections, or skin conditions that prevent the hygienic use of the VR headset.\n\nPre-existing severe vertigo, balance disorders, or high susceptibility to motion sickness.\n\nAcute clinical state involving high risk of agitation or behavioral dysregulation that could compromise participant or equipment safety.\n\nSevere visual or hearing impairments that cannot be corrected and would hinder the VR experience.\n\nPatients who have previously participated in the study during a prior admission are not eligible for re-enrolment.",{"count":104,"type":22},120,[25],"This study evaluates the feasibility, acceptability and clinical impact of a virtual reality (VR)- based nature intervention in an acute psychiatric inpatient unit. Participants are randomly assigned to recieve VR nature sessions (using Nature Treks VR on Meta Quest 3) in addition to standard care, or standard care alone. The primary outcome is change in percieved stress (PSS-19) from admission to discharge. The study uses a mixed-methods design combining randomized controlled trial with a qualitative phase.",[29,108,109],"Psychiatric Hospitalization","Stress (Psychology)",[111,112,113,114,115],"virtual reality","nature exposure","Acute psychiatry","Inpatient","Mental health","NOT_YET_RECRUITING","2026-06-12",{"date":119,"type":41},"2026-06-17",{"date":121,"type":22},"2026-06-10",{"date":123,"type":22},"2026-12",{"name":125,"class":48},"Hospital Clinic of Barcelona",{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":18,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":49},"100502590","implementation-of-refocus-training-program-in-mental-health-services-100502590","NCT05824234","Implementation of REFOCUS Training Program in Mental Health Services","Multicenter Study on the Implementation of a Training Program in the Orientation of Care Towards Recovery (REFOCUS) in Mental Health Services","RETAFORM","Inclusion Criteria:\n\n* Age from 15 to 65 years old.\n* Diagnosis of schizophrenia, schizoaffective disorder, schizotypal disorder and schizophreniform disorder or bipolar disorder, borderline personality disorder, disabling anxiety or depressive disorder (DSM-V criteria; APA, 2013).\n* Patients cared for by the team or unit benefiting from REFOCUS training\n* French mother tongue.\n* Patient affiliated or entitled to a social security scheme\n* Patient having received information about the study and having confirmed their participation in the study by signing the consent form\n* For minors (\\\u003C 18 years), information given to holders of parental authority and signature of consent.\n* For patients under curatorship, form signed by the patient and information given to the curator\n\nExclusion Criteria:\n\n* Age less than 15 years old\n* Patients under guardianship\n* Presence of an associated intellectual disability\n* Neurological disorders of vascular, infectious or neurodegenerative origin.\n* Taking somatic drugs with a cerebral or psychic impact (eg corticosteroids).","15 Years","65 Years",{"count":137,"type":22},760,[25],"Training of mental health service teams in the orientation of care towards recovery through a 3-day training course: REFOCUS. This training aims to orient care towards recovery. Following this training, evaluation of the effectiveness of the implementation of REFOCUS training in mental health services.",[29],{"date":117,"type":41},{"date":143,"type":41},"2023-06-19",{"date":145,"type":22},"2027-06-30",{"name":147,"class":48},"Hôpital le Vinatier",{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":18,"minAge":154,"maxAge":19,"enrollmentInfo":155,"targetDuration":4,"studyType":23,"phases":157,"briefSummary":158,"conditions":159,"keywords":165,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":49},"100642279","experimental-evidence-of-the-impact-of-parental-income-on-child-mental-health-and-neuroimmune-function-100642279","NCT07641244","Experimental Evidence of the Impact of Parental Income on Child Mental Health and Neuroimmune Function","Inclusion Criteria:\n\n* Child of a participant enrolled in the Every Dollar Counts intervention. Youth were between ages 5 and 14 at the start of the intervention (followed up when ages 10 to 18)\n* Biological parent who lives with the child must be part of the original income study\n* For the in-person neuroimaging subsample: family must live within a 2-hour drive of downtown Chicago\n\nExclusion Criteria:\n\n* Youth not between ages 5 and 14 at the start of the intervention\n* Parent not enrolled in the Every Dollar Counts program","10 Years",{"count":156,"type":22},500,[25],"Growing up in a lower-income family robustly predicts worse mental health in adolescence and early adulthood. How does variability in family income \"get under the skin\" of the developing child and via what mechanisms does it increase risk for mental illness? Moreover, could supplements to family income at critical developmental periods help to prevent later youth mental illness? To address these questions, we leverage an innovative existing double blind randomized controlled trial of 3-years of substantial income supplements to parents.\n\nBy experimentally studying the impacts of these income supplements on families and subsequent youth development, we can examine causal pathways from family income to risk for mental illness via family stress and neuroimmune mechanisms in ways never done before. Moreover, by measuring the longer-term impact of 3 years of income supplements to parents on their child's neuroimmune signaling and risk for mental illness, we can examine the policy implications for child development of unconditional cash transfers to parents and identify how and for whom these supplements help. We will test these basic and translational questions in a sample of 1,200 youth with lower-income parents randomly assigned to receive either a substantial monthly income supplement or a minimal monthly supplement for 3 years, starting when youth were between age 5 - 14 years old. We will follow up with youth and their parent 1 - 2 and 3 - 4 years after the intervention and examine whether income supplements predict better youth mental health during adolescence, as well as whether factors like child age and neighborhood quality modulate intervention effects. Additionally, we explore family stress mechanisms through which the intervention may impact child mental health. Finally, we will measure peripheral inflammation (inflammatory biomarkers and classical monocytes) and use MRI to assess threat, reward, and regulatory neural activity and connectivity among 500 of these youth. Our central hypothesis is that income supplements will decrease family and youth stress and improve parenting, which will improve neuroimmune signaling and decrease risk for psychopathology. Moreover, these effects will remain years after termination of the transfers and be strongest among families who received the intervention earlier in the child's life. This research will provide timely, relevant public health knowledge that will help policy makers understand the longer-term brain, immune, and mental health impacts of cash transfers to parents, while also advancing the science of the sociocontextual and neuroimmune pathways through which variability in family income impacts risk for psychopathology.",[160,161,162,29,163,164],"Psychopathology","Child Mental Health","Anxiety Disorders","Inflamation","Poverty",[73,34,166,167,168,164,161,160,169],"Internalizing Disorders","Externalizing Disorders","Inflammation","Stress","2026-06-08",{"date":172,"type":41},"2026-06-11",{"date":174,"type":41},"2026-04-04",{"date":176,"type":22},"2029-08-31",{"name":178,"class":48},"Northwestern University",{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":186,"minAge":19,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":23,"phases":190,"briefSummary":191,"conditions":192,"keywords":195,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":49},"100639374","understanding-and-targeting-self-regulatory-control-in-bulimia-nervosa-100639374","NCT07581158","Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa","Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa Via a Combined Real-Time Neurofeedback and Smartphone Intervention","Inclusion criteria:\n\n* Female\n* Aged 18 to 55 years\n* Meet diagnostic criteria for bulimia nervosa (BN) or BN of low frequency and\u002For limited duration\n* Current body mass index greater than or equal to 18.5kg\u002Fm2 but under 40kg\u002Fm2\n* English-speaking\n\nExclusion criteria:\n\n* Ongoing medical treatment or planned\u002Frecent change in medical treatment, major medical condition, or psychiatric disorder that may interfere with study variables or participation\n* Current psychotherapy focused primarily on eating disorder symptoms\n* Pregnancy or planned pregnancy, or lactation during the study period\n* Allergy to ingredients in the shake","FEMALE","55 Years",{"count":189,"type":22},40,[25],"The purpose of this study is to examine the effects of noninvasive prefrontal cortex (PFC) neurofeedback during eating in women with bulimia nervosa (BN) using wearable brain imaging, functional near-infrared spectroscopy (fNIRS), together with a brain-based 4-week text-messaging intervention. The investigators will examine how these interventions may influence inhibitory control and eating disorder symptoms in women with bulimia nervosa.",[193,194,29],"Bulimia Nervosa","Feeding and Eating Disorders",[196,197,198,199,200,201],"fNIRS","fNIRS neurofeedback","smartphone intervention","eating disorders","bulimia nervosa","bulimia","2026-05-06",{"date":204,"type":41},"2026-05-12",{"date":206,"type":22},"2026-04-25",{"date":208,"type":22},"2028-12-14",{"name":210,"class":48},"Icahn School of Medicine at Mount Sinai",{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":23,"phases":221,"briefSummary":222,"conditions":223,"keywords":226,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":49},"100353874","group-based-stabilization-and-skill-training-for-patients-with-lasting-posttraumatic-reactions-in-mental-health-care-100353874","NCT03887559","Group-based Stabilization and Skill Training for Patients With Lasting Posttraumatic Reactions in Mental Health Care","Adding a Group Based Stabilization and Skill Training Intervention for Patients With Long Lasting Posttraumatic Reactions Receiving Outpatient Treatment in Specialized Mental Health Care - A Randomized Controlled Trial","Inclusion Criteria:\n\n* Receiving treatment in ordinary out-patient clinics\n* Having been exposed to or witnessing to traumatic event(s) defined as \"one or several extremely threatening or horrific events or series of events or situations being of such a character which is likely to overwhelming distress in almost anyone in a similar situation\", measured by Stressful Life Events Screening Questionnaire\n* Presenting with posttraumatic reactions such as hyperarousal, avoidance, intrusions, emotional dysregulation or interpersonal difficulties.\n* Symptom duration for a minimum of six months.\n* Understand and speak Norwegian to an extent that is required to participate in a stabilization- and skill-training group.\n\nExclusion Criteria:\n\n* Active psychotic symptoms.\n* Substance or drug addiction or abuse.\n* High suicidal risk considered by the individual therapist.\n* Having participated in the course previously.","75 Years",{"count":220,"type":22},160,[25],"This study evaluates the addition of a group based stabilization and skill-training intervention to individual out-patient treatment for long lasting post-traumatic reactions. Half of the participants will receive the combined treatment while the other half will receive individual treatment as usual.",[224,29,225],"Stress Disorders, Post-Traumatic","Trauma and Stressor Related Disorders",[227],"Psychotherapy","2026-04-24",{"date":230,"type":41},"2026-04-30",{"date":232,"type":41},"2019-03-25",{"date":234,"type":22},"2027-12",{"name":236,"class":48},"St. Olavs Hospital",{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":244,"sex":18,"minAge":245,"maxAge":246,"enrollmentInfo":247,"targetDuration":4,"studyType":23,"phases":249,"briefSummary":250,"conditions":251,"keywords":260,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":271,"locationsCount":273},"100515295","brain-activity-among-children-with-overactive-bladder-and-daytime-urinary-incontinence-and-healthy-children-100515295","NCT05989646","Brain Activity Among Children With Overactive Bladder and Daytime Urinary Incontinence and Healthy Children","Brain Activity Among Children With Overactive Bladder and Daytime Urinary Incontinence and Healthy Children, and Modulation of Brain Activity by Transcutaneous Electrical Nerve Stimulation - a Functional Magnetic Resonance Imaging Study","Inclusion Criteria:\n\n* Overactive Bladder as per International Children's Continence Society criteria (cases only).\n* At least 2 incontinence episodes per week (cases only).\n* No urinary tract symptoms (healthy participants only).\n* More than 3 daily urinations.\n* Normal clinical examination.\n\nExclusion Criteria:\n\n* Known urogenital abnormality affecting the lower urinary tract function.\n* Prior surgery in the urinary tract (except circumcision).\n* Known neurological diseases or prior cerebral surgery.\n* Known neuropsychiatric disorders or suspicion of those by screening.\n* Treatment with pharmacological agents affecting the brain function.\n* Prior treatment with Enuresis Alarm or Transcutaneous Electrical Nerve Stimulation.\n* Prior or current treatment with mirabegron or oxybutynin.\n* Current urinary tract infection.\n* Current constipation according to Rome IV-criteria or faecal incontinence.\n* Claustrophobia.\n* Metallic items in the body contraindicating MRI-scans.\n* Abnormal uroflowmetry (healthy participants only).",true,"6 Years","14 Years",{"count":248,"type":22},65,[25],"The aim of this study is to investigate whether the activity in brain areas controlling the bladder is different among children suffering from Overactive Bladder (OAB) and Daytime Urinary Incontinence (DUI) compared to age- and gender-matched healthy children without bladder symptoms. Moreover, the aim is to investigate if sacral transcutaneous electric nerve stimulation (TENS) has a central mechanism of action. Children with OAB and DUI will be recruited from involved pediatric departments, and functional magnetic resonance imaging (fMRI) will be performed before and after 10 weeks of sacral TENS. In healthy children without bladder symptoms, only the baseline fMRI will be performed.",[252,253,254,255,256,257,258,75,29,259],"Urinary Incontinence","Daytime Wetting","Urination Disorders","Urination Involuntary","Urologic Diseases","Lower Urinary Tract Symptoms","Urological Manifestations","Elimination Disorders",[261,262,263,264],"Transcutaneous Electrical Nerve Stimulation","TENS","Functional Magnetic Resonance Imaging","fMRI","2026-04-15",{"date":267,"type":41},"2026-04-20",{"date":269,"type":41},"2021-05-05",{"date":234,"type":22},{"name":272,"class":48},"Aalborg University Hospital",4,{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":135,"enrollmentInfo":281,"targetDuration":4,"studyType":23,"phases":283,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":49},"100628840","auricular-stimulation-for-nicotine-withdrawal-in-psychiatric-inpatients-100628840","NCT07466875","Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients","The Efficacy of Auricular Acupressure Combined With Nicotine Replacement Therapy on Nicotine Craving, Withdrawal Symptoms and Anxiety Levels in Psychiatric Inpatients: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Psychiatric inpatients aged 18 to 65 years.\n* Diagnosed with a mental disorder according to ICD-10-CM criteria.\n* History of daily smoking within the past six months (Fagerström Test for Nicotine Dependence \\[FTND\\] score ≥ 2).\n* Experiencing nicotine withdrawal symptoms due to mandatory smoking cessation upon admission (Minnesota Tobacco Withdrawal Scale \\[MNWS\\] baseline score ≥ 5).\n* Agree to and comply with the standard-of-care Nicotine Replacement Therapy (NRT) provided by the hospital.\n* Capable of understanding the study procedures and providing written informed consent\n\nExclusion Criteria:\n\n* Presence of severe skin infection, open wounds, or lesions on the auricle (outer ear).\n* Severe coagulation disorders or currently taking high-dose anticoagulants (due to potential risk of bleeding or irritation).\n* Pregnant or breastfeeding women.\n* Significant language barriers or cognitive impairment that prevents completion of assessment scales or adherence to study protocols.\n* History of receiving auricular therapy for smoking cessation within the past three months.",{"count":282,"type":22},60,[25],"The goal of this clinical trial is to evaluate the feasibility and preliminary effectiveness of auricular acupressure (ear seeds) combined with nicotine replacement therapy (NRT) in psychiatric inpatients (both male and female, aged 18-65) who are forced to abstain from smoking due to the smoke-free environment of the inpatient ward. The main questions it aims to answer are:\n\n* Does auricular acupressure significantly reduce the severity of nicotine withdrawal symptoms compared to standard care?\n* Can auricular acupressure effectively lower nicotine craving and anxiety levels in patients during their mandatory abstinence? Researchers will compare the experimental group (NRT plus active auricular acupressure) to a control group (NRT plus sham auricular acupressure) to see if the addition of ear point stimulation provides better relief for withdrawal distress.\n\nParticipants will:\n\n* Receive standard nicotine replacement therapy (NRT) as prescribed by their physician.\n* Be randomly assigned to receive either Vaccaria segetalis seeds or sham materials on specific ear acupuncture points.\n* Be instructed to press the beads 3 times daily to stimulate the points for a period of 4 weeks.\n* Complete standardized assessments (MNWS, HAMA, and craving scales) at baseline and multiple time points during the intervention.",[286,287,288,34,29],"Nicotine Dependence","Nicotine Withdrawal","Tobacco Use Disorder","2026-04-06",{"date":291,"type":41},"2026-04-13",{"date":293,"type":41},"2026-03-23",{"date":295,"type":22},"2027-12-31",{"name":297,"class":48},"Chiao-Chiao Liao",{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":244,"sex":18,"minAge":306,"maxAge":307,"enrollmentInfo":308,"targetDuration":4,"studyType":310,"phases":4,"briefSummary":311,"conditions":312,"keywords":314,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":49},"100560723","psychiatric-multi-omics-and-neuroimaging-project-100560723","NCT06580860","Psychiatric Multi-omics and Neuroimaging Project","Psychiatric Multi-omics and Neuroimaging Project Database","PMNP","Inclusion Criteria:\n\n* Age: 13-35 years old(Patients with healthy siblings can be extended to 14-35 years of age)\n* Course of disease: \\\u003C24 months\n* Priority is given to patients who have never taken medicine or duration of drug use \\\u003C 2 weeks\n* No nuclear magnetic contraindications.\n\nExclusion Criteria:\n\n* Family history of psychotic disorders, history of psychoactive substances abuse, alcohol dependence, or nicotine dependence\n* Have a major physical disease or infectious disease\n* History of coma and serious neurological disease 4.MRI contraindications.","13 Years","35 Years",{"count":309,"type":22},1899,"OBSERVATIONAL","This study focuses on the structure and function of the brain and gene expression in peripheral blood of patients with schizophrenia, to explore the interaction and influence between the three. Patients with mental disorders who have been recruited will take their medication regularly for 1 year and participate in baseline and follow-up assessments.",[29,313],"Healthy Control",[315,316,317,318,319,320],"schizophrenia","major depressive disorder","autism spectrum disorder","bipolar disorder","magnetic resonance imaging","multi-omics","2026-03-11",{"date":323,"type":41},"2026-03-13",{"date":325,"type":41},"2016-01",{"date":327,"type":22},"2027-01",{"name":329,"class":48},"mingjun Zhong",{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":337,"enrollmentInfo":338,"targetDuration":4,"studyType":23,"phases":340,"briefSummary":341,"conditions":342,"keywords":344,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":363},"100627252","pharmacist-led-interventions-in-psychiatric-patients-100627252","NCT07446218","Pharmacist-led Interventions in Psychiatric Patients","Impact of Pharmacist-Led Interventions in Psychiatric Patients on Second Generation Antipsychotics","Inclusion Criteria:\n\n* Adults aged 18-60 years.\n* Diagnosed with schizophrenia, bipolar disorder, or major depressive disorder.\n* Currently prescribed a second-generation antipsychotic for \\\u003C 2 months.\n* Willing to participate in lifestyle and counseling sessions.\n\nExclusion Criteria:\n\n* Patients with severe medical comorbidities.\n* Pregnant or breastfeeding women.\n* Patients receiving only first-generation antipsychotics.\n* Patients taking more than three antipsychotics.\n* Patients using combination of first and second generation antipsychotics.\n* Individuals with cognitive impairment.\n* Patients with type 2 diabetes mellitus.","60 Years",{"count":339,"type":22},148,[25],"The goal of this intervention study is to examine the impact of pharmacist-led interventions in psychiatric patients initiating second-generation antipsychotic treatment. The primary purpose is to assess the impact of intervention on antipsychotic induced metabolic outcomes, such as weight gain and other cardiometabolic risk markers, in patients aged 18 to 60 years who have been diagnosed with chronic mental disorder. Participants will be assigned to either the intervention or the control group. The intervention group will receive educational interventions from the pharmacist at baseline, after 4 weeks, 8 weeks, and 12 weeks along with the standard therapy prescribed by the psychiatrist. On the other hand, the control group will receive only the standard therapy with no intervention from the pharmacist.",[29,343],"Metabolic Syndrome",[345,346,347,348,349,350,351,352,353],"severe mental illness","chronic mental disorder","atypical antipsychotics","intervention study","RCT","Pakistan","metabolic syndrome","second generation antipsychotics","educational intervention","2026-02-25",{"date":356,"type":41},"2026-03-03",{"date":358,"type":22},"2026-03-01",{"date":360,"type":22},"2026-05-31",{"name":362,"class":48},"University of Lahore",2,{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":310,"phases":4,"briefSummary":374,"conditions":375,"keywords":378,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":392,"leadSponsor":394,"locationsCount":49},"100627007","psychosocial-factors-in-dual-diagnosis-in-a-general-hospital-100627007","NCT07443033","Psychosocial Factors in Dual Diagnosis in a General Hospital","Psychosocial Protective Factors and Clinical-Functional Outcomes in Hospitalized Patients With Dual Diagnosis: An Observational, Cross-Sectional, Single-Center Study","DUAL-HVP","Inclusion Criteria:\n\n* Adults (≥18 years).\n* Hospitalized patients with a clinical diagnosis of dual diagnosis.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Severe cognitive impairment or acute clinical condition preventing assessment.\n* Refusal or inability to provide informed consent.",{"count":373,"type":22},125,"Dual diagnosis, defined as the co-occurrence of a mental disorder and a substance use disorder, is frequently associated with increased clinical severity, functional impairment, and poorer health outcomes. Identifying psychosocial protective factors related to better clinical and functional outcomes is essential to improve patient care and treatment planning.\n\nThe aim of this observational, cross-sectional, single-center study is to analyze psychosocial protective factors and their association with clinical-functional outcomes in hospitalized patients with dual diagnosis. The study will be conducted in a general hospital setting and will include adult inpatients diagnosed with dual diagnosis according to clinical criteria.\n\nSociodemographic, clinical, and psychosocial variables will be collected using standardized assessment tools and clinical records. The results of this study are expected to contribute to a better understanding of psychosocial factors associated with clinical severity and functional outcomes in patients with dual diagnosis, supporting more comprehensive and patient-centered care approaches.",[376,377,29],"Dual Diagnosis","Substance Use Disorder",[379,115,380,381,382,383,384,385,386,387],"Addiction psychiatry","Cross-sectional study","Observational study","Hospitalized patients","Functional outcomes","Clinical outcomes","Protective factors","Psychosocial factors","Dual diagnosis","2026-02-24",{"date":390,"type":41},"2026-03-02",{"date":358,"type":22},{"date":393,"type":22},"2027-04-30",{"name":395,"class":396},"Hospital Virgen del Puerto","OTHER_GOV",{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":23,"phases":405,"briefSummary":407,"conditions":408,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":426},"100545851","phase-3-optimizing-chronic-pain-care-with-mindfulness-and-chronic-pain-management-visits-100545851","NCT06387290","Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits","Inclusion Criteria:\n\n* Age 18 +\n* Current chronic pain diagnosis (pain for ≥3 months) determined by physician assessment\n* Prescribed long-term opioid therapy (≥3 months)\n* Score \\>=3 on the Pain Enjoyment General Activity scale\n* Score \\>=9 on the Current Opioid Misuse Measure OR lifetime psychiatric or substance use disorder diagnosis OR benzodiazepine use OR history of overdose OR patient or physician determination that risks of opioid use may outweigh the benefits of opioid use\n\nExclusion Criteria:\n\n* Chronic pain due to a cancer diagnosis\n* Active suicidal intent, schizophrenia, psychotic disorder\n* Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, Mindfulness-Based Relapse Prevention, or Mindfulness-Oriented Recovery Enhancement",{"count":404,"type":22},300,[406],"PHASE3","The primary aim of this implementation-effectiveness trial is to examine the effectiveness of Mindfulness-Oriented Recovery Enhancement (MORE) and patient-centered chronic pain management visits in primary care as interventions to reduce chronic pain, improve quality of life, and reduce opioid-related harms among chronic pain patients on long-term opioid therapy.",[409,410,411,412,413,414,29,415,416],"Chronic Pain","Prescription Opioid Misuse","Substance-Related Disorders","Pain","Narcotic-Related Disorders","Chemically-Induced Disorders","Opioid-Related Disorders","Neurologic Manifestations","2026-01-30",{"date":419,"type":41},"2026-02-03",{"date":421,"type":41},"2025-02-25",{"date":423,"type":22},"2028-05-01",{"name":425,"class":48},"University of Utah",3,{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":18,"minAge":337,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":23,"phases":437,"briefSummary":439,"conditions":440,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":463},"100384702","phase-4-cognitive-outcomes-after-dexmedetomidine-sedation-in-cardiac-surgery-patients-100384702","NCT04289142","Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients","Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients: CODEX Trial","CODEX","Inclusion Criteria:\n\n* Planned CABG (+\u002F- valve, including off-pump) or valve replacement via sternotomy\u002Fthoracotomy, with initial recovery in the Cardiovascular Intensive Care Unit (CVICU)\n* Age ≥60\n\nExclusion Criteria:\n\n* Lack of patient consent\n* Pre-operative major cognitive dysfunction (CogState Brief Battery score \\\u003C 80) at screening\n* Aortic arch replacement\u002Fre-implantation (surgery requiring hypothermic circulatory arrest, e.g. Bentall procedure)\n* Allergy\u002Fcontraindication to dexmedetomidine (untreated 2nd degree type 2 or 3rd degree heart block (pacemaker), cirrhosis, HR \\\u003C 50 , grade 4 LV, renal failure or on renal replacement therapy)\n* Unlikely to comply with study assessments (e.g. no fixed address, cannot complete cognitive tests at the 3, 6, and 12 month time points)",{"count":436,"type":22},2400,[438],"PHASE4","Anesthesia is a drug induced, reversible, comatose state that facilitates surgery and it is widely assumed that cognition returns to baseline after anesthetics have been eliminated. However, many patients have persistent memory impairment for weeks to months after surgery. Cardiac surgery appears to carry the highest risk of postoperative cognitive dysfunction (POCD). These cognitive deficits are associated with increased mortality, prolonged hospital stay and loss of independence. The investigators propose to investigate the role of Dexmedetomidine (DEX) in preventing long-term POCD after cardiac surgery and enhancing early postoperative recovery. It is anticipated that DEX will be the first effective preventative therapy for POCD, improve patient outcomes, and reduce length of stay and healthcare costs.",[441,442,443,444,29,445,446,416,447,448,449,450,451,70,452,453,67],"Delirium","Cognitive Dysfunction","Cognition Disorder","Neurocognitive Disorders","Confusion","Neurobehavioral Manifestations","Nervous System Diseases","Signs and Symptoms","Dexmedetomidine","Hypnotics and Sedatives","Central Nervous System Depressants","Analgesics, Non-Narcotic","Analgesics","2025-11-27",{"date":456,"type":41},"2025-12-01",{"date":458,"type":41},"2019-12-01",{"date":460,"type":22},"2029-03",{"name":462,"class":48},"Sunnybrook Health Sciences Centre",8,{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":23,"phases":474,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":4},"100603377","online-access-to-clinical-treatment-notes-for-outpatients-100603377","NCT07135726","Online Access to Clinical Treatment Notes for Outpatients","OpenNOTES: Online Access to Clinical Treatment Notes for Outpatients - an Interventional, Prospective, Controlled Mixed-methods Study","OpenNOTES","Inclusion Criteria:\n\nPatients (General, Module A \\& D):\n\n* Aged 18 years or older\n* Outpatient treatment at one of the four study centers\n* For intervention group: access to an internet-enabled device (e.g. smartphone, tablet, computer) and ability to receive text messages\n\nFor Module D:\n\n* Experience with the respective disease or medical field (e.g. via prior treatment experience or basic medical understanding)\n* At least one documented clinical treatment in the internal system of a participating center within the 12 months prior to intervention start\n* Availability of clinically relevant treatment notes (e.g. physician letters, progress notes, discharge summaries, consultation notes) suitable for anonymized analysis\n\nPatients (Control Group - Module A):\n\n•No requirement for access to an internet-enabled device\n\nHealthcare Practitioners (Modules A \\& D):\n\n* Aged 18 years or older\n* Employed at one of the study centers\n* Ability to give informed consent\n* For Module D: experience in relevant clinical field and familiarity with medical terminology and treatment standards\n\nRelatives (Module B):\n\n* Aged 18 years or older\n* Ability to give informed consent\n* Identified as family member, friend, or legal representative of a participating patient\n\nExperts (Module E):\n\n* Demonstrated expertise or professional experience in digital health Relevant experience with telematics infrastructure (TI), HL7 FHIR®, ePA, KIM, TIM, or affiliation with relevant institutions (e.g. gematik GmbH, HL7 Deutschland e.V., mio42 GmbH)\n* Participation in or co-design of health IT interoperability projects\n\nPatients and Physicians (Module E):\n\n* Good proficiency in German (workshops conducted in German)\n* Basic digital literacy and experience with digital technologies in healthcare\n\nExclusion Criteria:\n\nGeneral:\n\n* Insufficient German language skills\n* Severe organic brain disorders with cognitive impairment\n* Intellectual disability\n* Acute self-endangerment or danger to others at time of inclusion\n* Lack of capacity to provide informed consent\n* Lack of access to an internet-enabled device and inability to receive text messages (except in control group of Module A)\n\nModule D:\n\n* Clinical notes that cannot be anonymized due to legal, ethical, or technical restrictions\n* Presence of rare diagnoses or unique treatment histories that hinder effective anonymization",{"count":473,"type":22},1092,[25],"This study investigates the feasibility and impact of patient access to clinical notes written by their healthcare providers-a concept known as Open Notes. While international research has already demonstrated positive effects of Open Notes on patient empowerment and treatment outcomes, there is a lack of corresponding evidence for the German healthcare context. The quasi-experimental study therefore combines quantitative and qualitative methods to evaluate the effects of Open Notes on patient-reported outcomes as well as clinical practice.\n\nThe study is structured into five modules, each addressing specific research questions:\n\nModule A - Summative Outcome Evaluation in Patients: Does the use of Open Notes lead to a significant increase in patient-reported outcomes such as empowerment and self-efficacy? Module B - Formative Process Evaluation with Stakeholders: What experiences do patients, relatives and clinicians have with Open Notes and what challenges and barriers arise in their use? Module C - Changes in Clinical Documentation: How do language style and content of clinical notes change when they are shared with patients as Open Notes? Module D - Optimization through Artificial Intelligence: Can clinical notes be processed using artificial intelligence in a way that makes them easier for patients to understand compared to conventional medical documentation? Module E - Integration into National Data Infrastructure: What technical, organizational and legal requirements must be met to successfully integrate Open Notes into the national telematics infrastructure and the electronic health record or routine care? The overall goal is to identify both patient-related outcomes and structural conditions for the sustainable implementation of Open Notes in the German healthcare system. The use of artificial intelligence is intended to further enhance patient-centeredness while reducing the burden on clinical staff.",[29,477,478,479,480,481,482],"Chronic Disease","Primary Health Care","Outpatients","Internal Medicine","Aged","Comorbidity","2025-08-20",{"date":485,"type":41},"2025-08-22",{"date":487,"type":22},"2025-09-01",{"date":489,"type":22},"2028-02-29",{"name":491,"class":48},"Julian Schwarz",{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":498,"eligibilityCriteria":499,"healthyVolunteers":244,"sex":18,"minAge":187,"maxAge":500,"enrollmentInfo":501,"targetDuration":503,"studyType":310,"phases":4,"briefSummary":504,"conditions":505,"keywords":516,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":49},"100464026","biobank-and-brain-health-in-bordeaux-100464026","NCT05322343","Biobank and Brain Health in Bordeaux.","Biobank and Brain Health in Bordeaux. A Population-based Cohort to Study the Biology of Brain and Cognitive Aging in Young Seniors","B-cube","Inclusion Criteria:\n\nFor the main study:\n\n1. live in Bordeaux metropolitan area,\n2. be between 55 and 80 years old (included),\n3. selected in terms of socioeconomic level, according to a sampling strategy by age groups and income categories representative of the general population between 55 and 80 years of age\n4. be affiliated with the social security system,\n5. agree to take a blood sample for the biobank.\n\nFor the MRI sub-study: be between 55 and 75 years old (included). Inclusion criteria for the immune response substudy: be 70 years of age or older or participate in the MRI study; agree to take a supplemental blood sample for this substudy.\n\nExclusion Criteria:\n\nFor the main study: persons under guardianship (or more generally under protection), unable to give consent to participate.\n\nFor the MRI sub-study: have a contraindication to MRI examination (pacemaker, a valve prosthesis or any other internal electrical\u002Fmagnetic device; history of neurosurgery or aneurysm; claustrophobia; presence of metal fragments in the eyes, brain or spinal cord).","80 Years",{"count":502,"type":22},2050,"12 Months","B cube is a new generation cohort to study the determinants and natural history of brain aging, using molecular epidemiology, in a representative sample (N=2000) of the general population from the age of 55 (the approximate age of onset of the first cognitive disorders and a target population particularly receptive to prevention messages). Special interest will be given to nutrition, a promising environmental exposure for prevention.",[506,507,508,509,510,29,444,511,512,513,514,515,75,73,34],"Brain","Aging","Cognitive Aging","Immunosenescence","Mental Processes","Cognition","Brain Diseases","Dementia","Alzheimer Disease","Mental Health",[517,518,519,520,521,522,523,524,525,526,527,528,529],"Epidemiologic Methods","Risk factors","Public Health","Environmental Exposure","Exposome","Dietary Exposure","Diet","Food and Nutrition","Nutritional Status","Metabolomics","Systems biology","Environmental Biomarkers","Inflammation Mediators","2025-08-08",{"date":532,"type":41},"2025-08-11",{"date":534,"type":41},"2022-03-22",{"date":536,"type":22},"2030-03-22",{"name":538,"class":48},"University Hospital, Bordeaux",{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":4,"eligibilityCriteria":545,"healthyVolunteers":244,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":546,"targetDuration":4,"studyType":23,"phases":548,"briefSummary":549,"conditions":550,"keywords":551,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":49},"100599687","improving-patient-mental-health-with-psychotherapist-virtual-training-100599687","NCT07087730","Improving Patient Mental Health With Psychotherapist Virtual Training","Improving Patient Mental Health With Psychotherapist Virtual Training: A Practice- Research Network Study","Inclusion Criteria:\n\n* Therapist participants: The investigators will recruit mental health professionals who deliver psychotherapy in North American community settings; inclusion criteria: therapists are in good standing with their provincial or state regulatory college, their scope of practice includes individual psychotherapy for adults in North America; they are able to accept a minimum of 3 new participating patients into their current practice to conduct 6 consecutive therapy sessions via a secure, PHIPA compliant virtual meeting platform.\n* Patient Participants: Adults (\\> 18 years) residing in Canada or the United States who want to engage in therapy with a study therapist or who have recently sought services from a study therapist; inclusion criteria: have participated in fewer than 3 sessions with their study therapist and anticipate being able to see their study therapist for 6 sessions over the next 6 months.\n\nExclusion Criteria:\n\n* Therapist participants: The investigators will exclude therapists who are employed by an organization if the investigators cannot obtain organizational approval from their employer or coordinate data collection from an alternate virtual platform in instances where the employing organization does not permit the use of the study platform. Therapists will also be excluded if they have completed professional development workshop after 2017 with PPRNet.\n* Patient participants: The investigators will exclude patients if they: (a) have a psychotic or neurocognitive disorder that may preclude engagement in psychotherapy, (b) are in concurrent psychological treatment with another practitioner, (c) are at high risk of suicide or suicidal behaviors as assessed by their therapist (e.g., suicide attempt or hospitalization for suicidal behaviors in the past 6 months), or (d) for whom the therapist judge that approaching them with information about the study will be harmful.",{"count":547,"type":22},489,[25],"Several types of psychotherapy are equally effective to treat mental disorders. However, many patients remain symptomatic after treatment. The investigators demonstrated that a professional development training program to improve psychotherapists' skills at identifying and repairing therapeutic alliance tensions resulted in improved therapeutic alliance (an important therapeutic ingredient) and patient mental health outcomes. However, the investigators delivered this training program by conventional in-person workshops which limited access by psychotherapists living outside large urban centres. Further, post-study interviews with therapists suggested that cultural\u002Fdiversity factors complicated the therapeutic alliance.\n\nIn the current study, the investigators will test the effectiveness and acceptability of a virtually-delivered training program to psychotherapists in North America to improve their capacity to identify and repair problems in the therapeutic alliance, including tensions related to patient diversity. The investigators will also examine how acceptable the virtually-delivered training is to psychotherapists and whether they would use such training in their practice. Participants in the study will be community-based licensed psychotherapists and their patients engaging in therapy in North America. Patient mental health outcomes, therapeutic alliance, and diversity issues will be assessed by comparing outcome measures between three groups: 1) therapists complete a self-paced virtual course + consultation, 2) therapists complete synchronous workshop + consultation, 3) control: therapists do not complete training.\n\nThe team of investigators developed Canada's largest psychotherapy practice-research network and has expertise in clinical trials, diversity, and education research of virtual training. State of the art training is often out of the reach of therapists who live outside of urban centres, and the effectiveness and acceptability of providing training virtually is not well-studied in mental health care. This study will improve psychotherapists' effectiveness at managing the therapeutic alliance and issues related to diversity, and will improve patient mental health outcomes thus promising to reduce the burden of mental illness.",[29],[552,227,553,554,555,29,556],"Psychotherapists","Outcome Assessment, Healthcare","Cultural Diversity","Humans","Telemedicine","2025-07-18",{"date":559,"type":41},"2025-07-28",{"date":561,"type":41},"2023-08-02",{"date":563,"type":22},"2027-05-01",{"name":565,"class":48},"University of Ottawa",{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":572,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":310,"phases":4,"briefSummary":576,"conditions":577,"keywords":578,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":49},"100554793","obstacles-and-facilitators-to-the-treatment-of-police-officers-with-mental-health-disorders-100554793","NCT06503705","Obstacles and Facilitators to the Treatment of Police Officers With Mental Health Disorders","Qualitative Investigation Into the Obstacles and Facilitators to the Treatment of Police Officers With Mental Health Disorders","BASP","Inclusion Criteria:\n\n* Be an active, administrative police officer, or scientific and technical police officer of the national police in France for more than a year,\n* Or work for the Ministry of the Interior as support staff, or medical staff,\n* Agree to participate in the study,\n* Agree to talk about the problem without managerial or union preconceptions.\n\nExclusion Criteria:\n\n* Be in post for the Ministry of the Interior for less than a year.\n* Be stationed in the Bas Rhin department (France), where the principal investigator works.",{"count":575,"type":22},20,"Police officers are subject to various professional risk factors that can contribute to the occurrence of mental health difficulties such as depression, anxiety, and post-traumatic stress disorder. In previous work, low use of specialized care structures was noted. Added to this is the carrying of a weapon which represents an element facilitating the passage to self-aggressive action.\n\nThe objective of the study is to identify and describe the barriers and facilitators to the treatment of police officers facing mental health difficulties.",[29],[29,579,580,581,582,583],"Behavior Disorders","Anxiety Syndrome","Depression Syndrome","Mental health difficulties","Policmen","2025-05-23",{"date":586,"type":41},"2025-05-25",{"date":588,"type":41},"2024-07-08",{"date":590,"type":22},"2026-07-08",{"name":592,"class":48},"University Hospital, Strasbourg, France",{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":599,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":601,"enrollmentInfo":602,"targetDuration":4,"studyType":310,"phases":4,"briefSummary":604,"conditions":605,"keywords":615,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":363},"100590434","multimodal-imaging-and-biospecimen-collection-for-low-back-pain-lbpb-100590434","NCT06967363","Multimodal Imaging and Biospecimen Collection for Low Back Pain (LBPB)","Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Brain Function in Low Back Pain Patients: a Longitudinal Cohort Study","LBPB","Inclusion Criteria:\n\n1. Adults aged 18 to 80 years.\n2. Diagnosis of low back pain, defined as pain located between the lower costal margins and the gluteal folds, with or without leg pain.\n3. Eligible for surgical or non-surgical treatments.\n4. Willingness to undergo neuroimaging (fMRI), microbiota sampling, psychological assessments, and other related study procedures. Ability to provide written informed consent.\n\nExclusion Criteria:\n\n1. Severe neurological deficits requiring emergency surgery.\n2. Antibiotic or probiotic use within the past 4 weeks. Suffering from digestive diseases such as irritable bowel syndrome, gastric ulcer, duodenal ulcer, etc.;\n3. Diagnosed spinal infections, tumors, fractures, or inflammatory diseases (e.g., ankylosing spondylitis).\n4. Known severe psychiatric disorders (e.g., schizophrenia, bipolar disorder) that would interfere with study participation.Head trauma; history of substance abuse.\n5. Contraindications to MRI scanning (e.g., pacemaker, metallic implants, severe claustrophobia).\n6. Pregnant or breastfeeding women.\n7. Participation in another interventional clinical trial within the past 3 months.\n8. Working at night shifts or travelling across time zones in the past 6 months.\n9. Excessive consumption of coffee, tea.","85 Years",{"count":603,"type":22},360,"This prospective cohort study investigates the neurobiological, genetic, and psychosocial mechanisms underlying acute and chronic low back pain (LBP). Core objectives include establishing a high-quality biobank to support future research in connectomics, genomics, and biomarker discovery, and identifying predictors of pain progression and treatment response.\n\nThe study will also assess the impact of comorbid conditions such as anxiety, depression, and sleep disturbances on pain perception and clinical outcomes. Longitudinal analyses will explore the dynamic interplay between emotion, cognition, sleep, and pain to inform precision, mechanism-based interventions.\n\nFunctional imaging will be used to examine brain responses to nociceptive modulation, aiming to identify neural circuits involved in pain chronification. By integrating multimodal data-including neuroimaging, neurophysiology, microbiota profiling, polysomnography, and molecular assays-the study will define LBP subtypes, with a particular focus on nociceptive, neuropathic, and nociplastic mechanisms. The ultimate goal is to establish prognostic biomarkers and advance personalized strategies for LBP prevention and treatment.",[606,607,608,409,609,29,610,611,612,613,614],"Chronic Low Back Pain (CLBP)","Acute Low Back Pain","Low Back Pain","Acute Pain","Sleep Disorder","Fibromyalgia (FM)","Nociplastic Pain","Neuropathic Pain","Nonspecific Low Back Pain",[616,264,617,618,619,620],"chronic low pack pain","brain function","microbiota","nociplastic pain","treatment","2025-05-02",{"date":623,"type":41},"2025-05-13",{"date":625,"type":22},"2025-05-15",{"date":627,"type":22},"2028-12-31",{"name":629,"class":48},"Peking University Third Hospital",{"id":631,"slug":632,"hasResults":12,"nctId":633,"briefTitle":634,"officialTitle":635,"acronym":636,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":18,"minAge":638,"maxAge":135,"enrollmentInfo":639,"targetDuration":4,"studyType":23,"phases":640,"briefSummary":641,"conditions":642,"keywords":645,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":654,"lastUpdatePostDateStruct":655,"startDateStruct":657,"completionDateStruct":659,"leadSponsor":661,"locationsCount":49},"100590212","a-trial-of-extended-reality-activities-to-enhance-leisure-participation-among-inpatients-with-persistent-mental-health-conditions-100590212","NCT06964477","A Trial of Extended Reality Activities to Enhance Leisure Participation Among Inpatients With Persistent Mental Health Conditions","A Randomized Controlled Trial of an Extended Reality-Based Occupational Therapy Intervention to Improve Leisure Participation in Inpatients With Persistent Mental Health Conditions","XR-MHLP","Inclusion Criteria:\n\n* Adults aged 20 to 65 years\n* Diagnosed with chronic schizophrenia or schizoaffective disorder (ICD-10 F20.x or F25.x)\n* Hospitalized continuously for at least 6 months\n* Clinically stable with no acute psychiatric symptoms\n* Able to walk independently and communicate verbally\n* Mini-Mental State Examination (MMSE) score ≥ 24\n\nExclusion Criteria:\n\n* History of epilepsy, severe motion sickness, or other seizure-related conditions\n* Significant visual or auditory impairments that may interfere with XR experience\n* Physical conditions that limit participation in leisure activities\n* Current diagnosis of substance abuse or major organic brain disorder\n* Inability to distinguish between reality and virtual environments","20 Years",{"count":7,"type":22},[25],"The goal of this clinical trial is to evaluate the effects of an extended reality (XR)-enhanced occupational therapy leisure intervention on motivation, emotional engagement, and therapeutic participation among inpatients with chronic psychiatric conditions. The main questions it aims to answer are:\n\nCan the XR intervention improve leisure motivation, leisure-related attitudes, and emotional coping strategies in long-term hospitalized individuals with mental illness?\n\nDoes the XR intervention promote improvements in psychological health, volition, and occupational performance?\n\nResearchers will compare an XR-based leisure therapy group to a usual care group engaged in standard hospital leisure activities such as art, music, or reading. Participants will take part in weekly 40-minute sessions for 6 weeks. The XR group will use a custom-designed mobile VR program featuring immersive 360° leisure scenarios aligned with participants' interests and functional goals. Data collection includes standardized assessments (e.g., Interest Checklist, Volitional Questionnaire, COPM, PANSS) and semi-structured interviews to explore changes in motivation, coping, and perceived benefits.",[643,29,644],"Schizophrenia and Related Disorders","Inpatients",[646,647,648,649,650,651,652,653],"Leisure Activities","Virtual Reality Exposure Therapy","Augmented reality","Extend reality","Schizoaffective Disorder","Volition","Motivation","Emotional Regulation","2025-05-01",{"date":656,"type":41},"2025-05-09",{"date":658,"type":22},"2025-07-01",{"date":660,"type":22},"2025-10-31",{"name":662,"class":48},"Chia-Hui Hung",{"id":664,"slug":665,"hasResults":12,"nctId":666,"briefTitle":667,"officialTitle":667,"acronym":668,"eligibilityCriteria":669,"healthyVolunteers":244,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":670,"targetDuration":672,"studyType":310,"phases":4,"briefSummary":673,"conditions":674,"keywords":677,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":680,"lastUpdatePostDateStruct":681,"startDateStruct":683,"completionDateStruct":685,"leadSponsor":686,"locationsCount":49},"100567882","immunoinflammatory-state-detection-and-multimodal-brain-imaging-and-electrophysiologic-changes-in-schizophrenia-100567882","NCT06673966","Immunoinflammatory State Detection and Multimodal Brain Imaging and Electrophysiologic Changes in Schizophrenia","SZIM","Inclusion Criteria:\n\n1. Clinical diagnosis that meets ICD-11 criteria for schizophrenia.\n2. Confirmation of the diagnosis of schizophrenia using the SCID-5-RV.\n\nExclusion Criteria:\n\n1. Clinical diagnosis or SCID-5-RV assessment confirming neurodevelopmental disorders, bipolar and related disorders, substance use disorders (excluding alcohol and tobacco).\n2. Presence of severe or acute physical illnesses, including traumatic brain injury, intracranial space-occupying or infectious diseases, acute cardiovascular diseases, acute respiratory system diseases, acute hematological disorders, autoimmune disease, etc.\n3. Presence of clearly defined genetic diseases, including tuberous sclerosis, multiple sclerosis, Kleefstra syndrome, 22q11.2 deletion syndrome, Prader-Willi syndrome, Klinefelter syndrome (47, XXY), etc.",{"count":671,"type":22},200,"3 Months","Schizophrenia is a severe mental illness that seriously affects the health and functioning of patients. Previous studies have found immunoinflammatory abnormalities in the blood, cerebrospinal fluid, central nervous system, and neuroimaging of people with schizophrenia, along with therapeutic effects of anti-inflammatory drugs on schizophrenia. These evidences suggest a close relationship between schizophrenia and immunity and inflammation. Therefore, we consider that the state of immune inflammation is a potential subtype classification basis for schizophrenia, and hypothesize that immune classification based on peripheral-central multidimensional data is related to patient's response to medication and cognition.",[675,676,29],"Schizophrenia","Schizophrenia Spectrum and Other Psychotic Disorders",[675,678,679],"immunity","inflammation","2025-04-22",{"date":682,"type":41},"2025-04-24",{"date":684,"type":41},"2025-01-10",{"date":627,"type":22},{"name":687,"class":48},"Central South University",{"id":689,"slug":690,"hasResults":12,"nctId":691,"briefTitle":692,"officialTitle":693,"acronym":4,"eligibilityCriteria":694,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":695,"targetDuration":4,"studyType":23,"phases":696,"briefSummary":697,"conditions":698,"keywords":700,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":701,"lastUpdatePostDateStruct":702,"startDateStruct":704,"completionDateStruct":706,"leadSponsor":708,"locationsCount":49},"100587604","effectiveness-of-smoking-cessation-education-100587604","NCT06930547","Effectiveness of Smoking Cessation Education","Investigation of the Effectiveness of Smoking Cessation Education in Patients Registered at a Community Mental Health Center: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Being registered with TRSM (Community Mental Health Center)\n* Being in the remission phase (the period after the patient's treatment is completed, with no observed active symptoms and improved insight)\n* Smoking at least one cigarette per day regularly\n* Being open to communication and collaboration\n* Being over the age of 18\n* Volunteering to participate in the study.\n\nExclusion Criteria:\n\n* Not being registered with TRSM (Community Mental Health Center)\n* Not being in the remission phase (presence of active symptoms or lack of improved insight)\n* Smoking less than one cigarette per day\n* Being unwilling or unable to communicate and collaborate effectively\n* Being under the age of 18\n* Not volunteering or unwilling to participate in the study.",{"count":282,"type":22},[25],"Smoking is an important psychosocial problem that concerns society. It is reported that 1.3 billion people use tobacco products in the world and approximately 6 million people lose their lives due to smoking every year. Despite the high mortality rate, smoking addiction is shown as one of the biggest preventable diseases and causes of death. Individuals with mental health problems have a much higher smoking rate than the general population. Studies show that people with severe mental disorders such as schizophrenia, bipolar disorder and major depression have a smoking rate three to four times higher than the general population. It has been reported that this high smoking rate is associated with more morbidity, mortality and increased healthcare costs in individuals with severe mental disorders.\n\nIt is reported that nurses, who spend the most time with patients and constitute the largest group of healthcare personnel, have an effective role in smoking cessation initiatives. The importance of nurses in tobacco control is emphasized in the publication titled \"Nurses for a Tobacco-Free Life\" by the International Council of Nursing (ICN). Although both national and international literature demonstrates that smoking is a serious problem in individuals with severe mental illness through descriptive research results, it is seen that smoking cessation intervention studies are quite limited. Randomized controlled intervention studies examining the effectiveness of smoking cessation interventions applied by nurses to individuals with severe mental illnesses could not be found in the literature. This study will be conducted to examine the effectiveness of smoking cessation education in patients registered in a community mental health center.\n\nIn light of this information, this study was planned as a randomized controlled study to examine the effectiveness of smoking cessation education in patients registered in a community mental health center. The data obtained from this study will reveal the effectiveness of smoking cessation education in individuals with severe mental illnesses and contribute to filling the gap in the literature in this area. In addition, a method for using smoking cessation education in individuals with severe mental illnesses will be presented with a high level of evidence study.",[288,29,699],"Smoking Cessation",[288,29,699],"2025-04-09",{"date":703,"type":41},"2025-04-16",{"date":705,"type":41},"2024-12-05",{"date":707,"type":22},"2025-08-15",{"name":709,"class":48},"Erzurum Technical University",{"id":711,"slug":712,"hasResults":12,"nctId":713,"briefTitle":714,"officialTitle":715,"acronym":716,"eligibilityCriteria":717,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":718,"targetDuration":4,"studyType":23,"phases":720,"briefSummary":721,"conditions":722,"keywords":725,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":732,"lastUpdatePostDateStruct":733,"startDateStruct":735,"completionDateStruct":737,"leadSponsor":739,"locationsCount":49},"100559669","a-group-based-treatment-for-self-stigma-in-people-with-mental-disorders-in-north-east-italy-100559669","NCT06567145","A Group-based Treatment for Self-stigma in People With Mental Disorders in North-east Italy","Assessing the Effectiveness and Feasibility of Group-based Treatment for Self-stigma in People With Mental Disorders: a Pragmatic Multisite Randomized Controlled Trial in Routine Mental Health Services in North-east Italy","NECT-ITA","Inclusion Criteria:\n\n1. Participants must be 18 years or older.\n2. Individuals must have a diagnosis of schizophrenia, schizoaffective disorder, schizoid disorder, schizophreniform disorder, bipolar I or II disorder, or major depressive disorder, according to DSM-5 criteria.\n3. Participants must be outpatients with clinical stability for at least 3 months, with no changes in pharmacological treatment during this period.\n4. Participants must have sufficient knowledge of written and spoken Italian.\n5. Participants must score above 1 on the ISMI (Internalized Stigma of Mental Illness) scale, indicating at least moderate levels of self-stigma.\n\nExclusion Criteria:\n\n1. Individuals unable to provide informed consent are excluded.\n2. Participants with intellectual disabilities are excluded.\n3. Individuals with primary diagnosis of personality disorder or substance dependence condition are excluded.\n4. Participants engaged in other programs that could influence self-stigma (e.g., social cognitive rehabilitation, social skills training) during the study are excluded.",{"count":719,"type":22},416,[25],"Self-stigma refers to the internalization of negative stereotypes by individuals with mental disorders, leading to beliefs that they are dangerous, aggressive, or incapable of working. This phenomenon has harmful effects on various aspects of life, such as adherence to treatment, self-esteem, quality of life, and can increase feelings of despair and suicide risk. To address these issues, the Narrative Enhancement and Cognitive Therapy (NECT) was developed. NECT is a group-based intervention consisting of 20 sessions designed to reduce self-stigma in individuals with mental disorders.\n\nThis study aims to evaluate the efficacy and feasibility of NECT in 416 patients from 26 mental health centers in Northeast Italy. It is structured as a pragmatic, multicenter, randomized controlled trial with two parallel arms. The study will assess the impact of NECT on several psychological dimensions, including levels of self-stigma, self-esteem, hope, empowerment, perception of recovery, mental well-being, and stigma-related stress. The findings of this research are expected to contribute to the understanding of effective treatments for patients with mental disorders, particularly those burdened by high levels of self-stigma, and to improve their recovery outcomes.",[723,29,724],"Stigma","Self-stigma",[726,727,728,729,730,731],"stigma","narrative enhancement cognitive therapy","narrative therapy","cognitive therapy","mental disorders","self-stigma","2024-11-21",{"date":734,"type":41},"2024-11-26",{"date":736,"type":41},"2024-10-01",{"date":738,"type":22},"2025-10-01",{"name":740,"class":48},"Universita di Verona",{"id":742,"slug":743,"hasResults":12,"nctId":744,"briefTitle":745,"officialTitle":745,"acronym":746,"eligibilityCriteria":747,"healthyVolunteers":244,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":748,"targetDuration":4,"studyType":310,"phases":4,"briefSummary":750,"conditions":751,"keywords":753,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":759,"lastUpdatePostDateStruct":760,"startDateStruct":762,"completionDateStruct":764,"leadSponsor":766,"locationsCount":49},"100498718","contribution-of-psychological-autopsy-to-the-understanding-of-suicidal-behaviors-in-french-overseas-territories-100498718","NCT05773898","Contribution of Psychological Autopsy to the Understanding of Suicidal Behaviors in French Overseas Territories","AUTOPSOM","Inclusion Criteria:\n\n* Persons close of the deceased\n* Persons who knew about his\u002Fher childhood\n* Age 18 or over\n* Interviewed for the study between 2 and 11 months after the suicide\n\nExclusion Criteria:\n\n* People with neuropsychiatric disorders that may affect the quality of the information collected, cognitive (memory and expression) and judgmental functions\n* People who refuses to participate\n* Persons referred to articles L.1121-6, L.1121-7, L. 1121-8 L.1121-1-2 of the French Public Health Code.",{"count":749,"type":22},150,"The mains objectives of our project are to coordinate the monitoring of suicides and to identify common or specific suicide risk factors in four overseas DROM-COM (French Polynesia, La Reunion, French Guiana and Martinique) by comparing to a site in mainland France (Amiens). A mixed approach (quantitative and qualitative) will be used, based on semi-directed interviews of the psychological autopsy type.",[64,29,752],"Prognostic Factors",[64,754,755,756,757,758],"Psychological autopsies","epidemiology","risk factors","psycholinguistic approach","French overseas territories","2024-09-24",{"date":761,"type":41},"2024-09-26",{"date":763,"type":41},"2024-01-25",{"date":765,"type":22},"2025-04",{"name":767,"class":48},"University Hospital Center of Martinique",{"id":769,"slug":770,"hasResults":12,"nctId":771,"briefTitle":772,"officialTitle":773,"acronym":4,"eligibilityCriteria":774,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":775,"targetDuration":4,"studyType":310,"phases":4,"briefSummary":777,"conditions":778,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":779,"lastUpdatePostDateStruct":780,"startDateStruct":782,"completionDateStruct":784,"leadSponsor":785,"locationsCount":21},"100399150","french-observatory-of-electroconvulsive-therapy-ect-100399150","NCT04477434","French Observatory of ElectroConvulsive Therapy (ECT)","Observatoire National d'ElectroConvulsivoThérapie (ECT)","Inclusion Criteria:\n\n* Patients consecutively referred for ECT.\n\nExclusion Criteria:\n\n* Not specified",{"count":776,"type":22},2000,"Since the 30s, ECT has been a psychiatric treatment mainly used for drug-resistant depressive illnesses. Clinical studies have shown its therapeutic efficiency compared to standard treatments also in other psychiatric illnesses. Although efficient, ECTs also induce side effects. In France, there is currently no consensus on providing the suitest medical care. It is therefore important to review our nowadays health care models in order to maintain and improve the recommendations of the French National Agency for Accreditation and Evaluation in Health, the last of which date from 1997! Within this context, this project has the dual objective of (1) identifying ECT medical procedure in France and (2) developing research to evaluate and to improve the effectiveness of this treatment.",[29],"2024-08-19",{"date":781,"type":41},"2024-08-20",{"date":783,"type":41},"2018-04-24",{"date":234,"type":22},{"name":786,"class":48},"Centre Hospitalier Henri Laborit"]