[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Universiteit Leiden\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":173},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,51,79,109,141],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100631701","adhdme-targeting-self-esteem-in-youth-with-adhd-100631701",false,"NCT07504107","ADHD&me: Targeting Self-esteem in Youth With ADHD","ADHD&me: a Randomized Controlled Trial to Target Self-esteem in Youth With ADHD","ADHD&me","Inclusion Criteria:\n\n* 16-25 years old.\n* Official ADHD diagnosis, that is confirmed by research team using the clinical interview MINI-S.\n* Low self-esteem, determined through a structured and multi-step procedure to minimize subjectivity:\n\n  * Referral by clinician. Clinicians from participating institutions identify potential participants. To ensure a uniform understanding of the study population and inclusion criteria, all clinicians receive specific training. The researcher(s) conduction the baseline assessment are also familiar with these training materials, so that the inclusion procedure is applied consistently.\n  * Telephone screening. Two items from the Rosenberg Self-Esteem Scale (RSES; Rosenberg, 1965) are administered (\"At times I think I am no good at all\" and \"All in all, I am inclined to think I am a failure\"). A score of 3 (agree) or 4 (strongly agree) on either of these items is considered indicative of low self-esteem.\n  * Baseline confirmation. During the baseline measurement, the full Rosenberg Self-Esteem Scale is administered. A cutoff score of \\\u003C 15 is used as an objective reference point. This score is combined with a standardized clinical interview conducted by a trained researcher psychologist. At the ADHD section of the MINI-S at the baseline measurement, participants are asked by the researcher psychologist how their symptoms interfere with domains such as work, study, relationships, and self-esteem. If self-esteem is not mentioned, a follow-up question will be asked: \"Many people with ADHD feel their symptoms affect their self-esteem, for example due to repeated negative feed- back, feeling like they are not good at things, or failing short. Do you recognize this in yourself\"? Based on the participant's response, the trained researcher psychologist interviewer forms a professional, clinical impression of whether there are indicators of persistently low self-esteem (i.e.,insecurity, fear of failure, strong reactions to criticism, perfectionism, distress related to ADHD symptoms). This clinical assessment approach is based on examples provided by the Diagnostic Interview for ADHD in Adults (DIVA-2-NL; Kooij \\& Francken, 2010). In all doubtful cases, the inclusion decision will be discussed in consensus meetings with the research team and supervisor, ensuring high inter-rater reliability.\n* Pharmacological treatment for ADHD is allowed, but medication dose should be stabilized for a minimum of 4 weeks at baseline measurement (T0). Although changes in ADHD medication during the study are not preferred, they may occur in practice. Any such changed will be carefully documented.\n\nExclusion Criteria:\n\n* Concurrent psychopathology that requires immediate attention (e.g., severe depression, suicidal thoughts\u002Frisk of suicide (as determined by the referring therapist and\u002For research team). Other comorbidity is allowed.\n* Undergoing any concurrent psychological treatment during the study, including any form of therapy for ADHD (e.g., CBT for planning skills). Psychoeducation completed prior to the study entry is allowed, but not during the study.\n* Low self-esteem that directly stems from a traumatic experience, which would indicate the need for trauma-specific treatment. This will be determined by the referring therapist. If someone in addition suffers from low self-esteem due to the ADHD symptoms, an appropriate timing of each treatment will be dis- cussed by the referring therapist and potential client.\n* IQ \\\u003C 80 assessed with two WAIS-IV subscales (Wechsler, 2008): Vocabulary and Block Design.\n* Severe substance use (as determined by the referring therapist and\u002For research team).\n* Confirmed Autism Spectrum Disorder (ASD) diagnosis. This also applies when the referring therapist indicates that an ASD diagnosis is very likely, even if it has not yet been established. Since ASD diagnostic procedures are time-consuming and fall outside the scope of this research project, formal ASD assessment will not be conducted within this study.\n\nNote. If included participants receive unforeseen supportive sessions outside the research setting, or if unforeseen medication changes occur during the study, these will be documented and considered during the analysis.","ALL","16 Years","25 Years",{"count":21,"type":22},110,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to learn whether the ADHD\\&me (ADHD\\&ik) intervention can improve self-esteem in youth aged 16-25 years with Attention Deficit Hyperactivity Disorder (ADHD). The ADHD\\&me program is a cognitive behavioral therapy (CBT)-based intervention designed to help people with ADHD to develop a more positive view of themselves in their transition to adulthood.\n\nThe main questions it aims to answer are:\n\n* Does the ADHD\\&me intervention improve self-esteem in youth with ADHD, and are these effects maintained over time?\n* Does the intervention also improve related outcomes, such as masking of ADHD-related behaviors and co-occurring mental health symptoms including anxiety, depression, and stress?\n\nIn this RCT, participants are assigned either to immediate treatment or to a waitlist control condition, with the latter receiving the intervention after an eight-week delay.\n\nParticipants will:\n\n* Take part in seven individual therapy sessions according to the ADHD\\&me intervention.\n* Complete questionnaires about self-esteem, masking of ADHD-related behaviors, ADHD symptoms, and co-ccurring mental health symptoms at several time points.\n* Complete short daily assessments (ecological momentary assessment) during one week at the start of the study and one week after the intervention or waitlist period to report momentary self-esteem, emotions, distress, and activities.",[28],"ADHD",[28,30,31,32,33,34,35,36,37],"Self-esteem","Masking","Comorbidity","Young adults","Youth","CBT","Intervention","RCT","RECRUITING","2026-05-11",{"date":41,"type":42},"2026-05-14","ACTUAL",{"date":44,"type":42},"2026-03-25",{"date":46,"type":22},"2028-03-31",{"name":48,"class":49},"Universiteit Leiden","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100610306","prepare-the-mind-can-coaching-in-goal-directed-behaviour-increase-the-success-of-cognitive-rehabilitation-in-people-with-ms-100610306","NCT07225868","Prepare the Mind: Can Coaching in Goal-directed Behaviour Increase the Success of Cognitive Rehabilitation in People With MS?","Inclusion Criteria:\n\n* Confirmed relapsing remitting or secondary progressive MS diagnosis according to the McDonald 2017 criteria\n* Expanded Disability Status Scale (EDSS) score \\\u003C 7\n* Relapse free period ≥ 3 months\n* Unchanged disease modifying therapy for ≥ 2 months at time of inclusion\n* Age 18-65 years\n* Language Dutch, English or German for each centre respectively\n\nExclusion Criteria:\n\n* High conscientiousness, measured with a T score 65 or higher on the BFI-2 subscale for conscientiousness\n* Current or prior brain trauma or neurological condition (other than MS)\n* Psychiatric disorder that heavily impacts cognitive and\u002For daily functioning\n* Medication intake and\u002For substance abuse that has an influence on cognitive functioning\n* For Dutch subsample undergoing MRI: Contradiction for MRI","18 Years","65 Years",{"count":60,"type":22},126,[25],"People with Multiple Sclerosis (MS) often experience cognitive difficulties such as memory problems, concentration issues, and reduced processing speed. These symptoms can have a negative impact on daily functioning and overall quality of life. Previous research on cognitive rehabilitation has shown that regular training focused on memory and concentration can have positive effects on cognitive functioning, including processing speed, memory, and executive functions that support daily activities. Moreover, fMRI studies (brain scans that measure brain activity) have revealed changes in brain activation following cognitive rehabilitation.\n\nRecently, the idea has emerged that a more personalized approach could improve treatment outcomes. Specifically, researchers have identified a link between personality traits and cognitive functioning. Since every individual is different, current cognitive rehabilitation programs often fail to take these personal differences into account.\n\nIn this project, the investigators aim to enhance the effectiveness of cognitive rehabilitation by focusing more closely on individual characteristics through an app-based training program. Participants will complete a 12-week app training prior to a 6-week cognitive rehabilitation program. The first app focuses on mindset training, supported by a coach. Afterwards, all participants will use a second app designed to train processing speed and memory. In addition to cognitive functioning, the investigators will also examine psychological, (neuro)biological, and social changes using questionnaires and fMRI. This research may provide valuable insights into how cognitive functioning and quality of life in people with MS can be improved.\n\nThis study is funded by the National MS Fund and is a collaboration between several institutions: the Department of Health, Medical and Neuropsychology at Leiden University (The Netherlands), the University at Buffalo (USA), and Reha Rheinfelden (Switzerland).",[64],"Multiple Sclerosis",[64,66,67,68,69],"Conscientiousness","Cognitive Rehabilitation","Brain Imaging","Quality of Life","2025-11-06",{"date":72,"type":42},"2025-11-10",{"date":74,"type":22},"2025-11-01",{"date":76,"type":22},"2028-12-31",{"name":48,"class":49},3,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":17,"minAge":18,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},"100548624","rct-the-effectiveness-of-lifehack-in-improving-mental-wellbeing-in-university-students-100548624","NCT06423417","RCT: the Effectiveness of LifeHack in Improving Mental Wellbeing in University Students.","LifeHack: RCT Evaluating the Effectiveness of a Guided E-health Programme in Improving Mental Wellbeing in University Students.","Inclusion Criteria:\n\n* Being fluent in Dutch and\u002For English\n* Being enrolled as a student at one of the 9 participating universities\n* Being 16 years of age or older\n* Having access to a PC or mobile device with internet access\n* Provide informed consent before participation\n* Score of 50 or lower on the MHC-SF. This is 1 SD above the mean baseline score of participants of LifeHack. This inclusion criterion ensures no students with optimal mental wellbeing are included because they will not be able to show any change.",true,"99 Years",{"count":89,"type":22},217,[25],"Psychological issues are common among university students and affect mental wellbeing. The Caring Universities (CU) project, involving nine Dutch universities, aims to enhance students' mental health through an annual online questionnaire and a platform offering guided eHealth interventions. One intervention, LifeHack, utilizes cognitive behavioral therapy-based modules to improve mental wellbeing by enhancing resilience and life skills. The effects of LifeHack with pre-post measurements (total n = 216 at post-test) found found that LifeHack led to improvements in mental wellbeing, but dropout rates were influenced by lack of motivation and module relevance. A personalized version of LifeHack is being developed to address these issues and will be evaluated in an RCT to assess its effectiveness in improving mental wellbeing and related outcomes among university students.",[93,94,95,96,97,69,98,99],"Internet-based Intervention","Waiting List Control Group","Depression","Anxiety","Stress","Mental Wellbeing","Resilience","2025-06-17",{"date":102,"type":42},"2025-06-22",{"date":104,"type":42},"2023-11-01",{"date":106,"type":22},"2025-07-31",{"name":48,"class":49},2,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":50},"100576630","reducing-itch-with-hypnosis-and-virtual-reality-100576630","NCT06787794","Reducing Itch With Hypnosis and Virtual Reality","The Effectiveness of Virtual Reality-assisted Hypnosis in Reducing Itch: a Proof-of-concept Study","VRITCH","Inclusion Criteria:\n\n* Participants must be adults (aged 18-80 years)\n* Participants must have been suffering from chronic pruritus of any origin for at least 1 year prior to inclusion in this study\n* Participants must have been seen by a physician for the itch\n* Participants must experience psychological and\u002For functional impairment due to the itch despite standard medical treatment.\n* Participants must speak and understand Dutch and be able to complete questionnaires.\n\nExclusion Criteria:\n\n* Severe psychiatric comorbidities irrelated to their itch condition such as psychosis or severe clinical depression or anxiety disorder (anxiety and depressive symptoms in itself are common in individuals with chronic symptoms and therefore no reason for exclusion);\n* History of seizures;\n* History of severe migraine;\n* Severe susceptibility to motion sickness;\n* Balance problems;\n* Face, head, or neck injury;\n* Visual or audiological impairment;\n* Pacemaker, defibrillator and\u002For other electronic (implantable) device of vital importance;\n* Pregnancy;\n* Lactation;\n* Participation in another interventional itch study.","80 Years",{"count":119,"type":22},30,[25],"Chronic itch is a disabling condition with currently limited treatment options. Virtual reality (VR) is a relatively new approach that provides immersion in another environment and has been shown to have a temporary itch mitigating potential. Hypnosis, which is a state of relaxation, has been successfully applied with more long-term treatment effects in the specific case of itch as a result of severe atopic dermatitis. However, hypnosis tends to depend on an individual's susceptibility, or ease, to come into a hypnotic state. A combination of VR and hypnosis (VRH) has been put forward since it may combine the longer lasting effects of hypnosis with VR making the hypnosis more accessible by facilitating imagination. Even though VRH is a promising avenue, it has never been investigated in the context of itch. In this randomized controlled trial, comparing a VRH treatment with a waiting list control group after 6 sessions and at follow-up, it is aimed to assess the effectiveness of VRH in reducing itch along with its psychological burden in adult individuals with therapy-resistant disabling itch.",[123,124],"ITCH","Pruritus",[126,127,128,129,130,131,132],"Chronic Pruritus","Chronic Itch","Therapy resistant","Virtual Reality (VR)","Hypnosis","Relaxation","Distraction","2025-03-24",{"date":135,"type":42},"2025-03-25",{"date":137,"type":42},"2025-01-31",{"date":139,"type":22},"2026-12-31",{"name":48,"class":49},{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":151,"conditions":152,"keywords":155,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":108},"100512937","bioclock-bright-light-therapy-for-depressive-disorders-100512937","NCT05958940","BioClock: Bright Light Therapy for Depressive Disorders","BioClock: Optimization, Working Mechanisms and Response Predictors of Bright Light Therapy for Depressive Disorders - a Multicentre Randomized Controlled Trial","Inclusion Criteria:\n\n* Age between 18 and 65.\n* Diagnosis of unipolar or bipolar depression (seasonal or non-seasonal) as assessed with the Mini-International Neuropsychiatric Interview (M.I.N.I.)\n* A current depressive episode (a score of 6 or higher on the Quick Inventory of depressive symptomatology Self Report (QIDS-SR)\n* Sufficient knowledge of Dutch or English language to fill in questionnaires\n* Provided Informed consent\n\nExclusion Criteria:\n\n* A current (hypo)manic or mixed episode (as assessed with the M.I.N.I.)\n* Current psychotic episode (as assessed with the M.I.N.I.)\n* Prominent active suicidality (score 10 or higher on the M.I.N.I. module)\n* Antidepressant therapy (medication, psychotherapy or BLT, or other forms of specific treatments for depression) that started less than 2 months prior to study entry\n* participants with bipolar disorder should be in mood-stabilizing treatment for at least 1 month in a recommended dosage,\n* Use of melatonin or agomelatine in the last month\n* Current use of antibiotics\n* Current use of light sensitivity increasing medication\n* Travelled across more than 1 time zone during past month or during the treatment\n* Travelled to sunny holiday locations\u002Fwinter sports during past month\n* pre-existing eye and skin disorders (retinitis pigmentosa, porphyria, chronic actinic dermatitis and sun-induced urticaria)\n* Systemic disorders with potential retinal involvement (rheumatoid arthritis and systemic lupus erythematosus)\n* Suffering from colour blindness (assessed by Ishihara colour plates)\n* Participated in night shift work in the last three months\n* (Retinal) blindness, severe cataract and glaucoma\n* Light-induced migraine or epilepsy\n* Pregnancy, or parents with a child younger than 18 months old",{"count":149,"type":22},231,[25],"Bright Light Therapy (BLT) is a proven treatment for depression in seasonal and non-seasonal depressive disorders, as well as bipolar disorder. To make BLT more effective and practical in clinical settings and tailor it to individual needs, it is necessary to optimize the treatment approach, understand how the treatment works, and identify patient characteristics that predict response.\n\nThis clinical trial has three main goals:\n\n* Optimize the administration of BLT for patients with depressive episodes.\n* Gain a deeper understanding of the treatment mechanisms.\n* Determine which patients benefit the most from the treatment.\n\nThe specific objectives are as follows:\n\n* Investigate whether additional treatments and interventions related to lifestyle and the biological clock can enhance the effects of BLT.\n* Examine how BLT influences the body's internal clock and sleep quality, and how these factors contribute to the outcomes.\n* Identify patient characteristics and behaviours that can predict treatment outcomes.\n* Develop a brain model to better understand the impact of BLT on the brain.\n\nIn this study, patients will receive BLT with a light intensity of 10,000 lux for 30 minutes each morning over 5 consecutive days. The treatment duration will range from one to three weeks, depending on the improvement of depressive symptoms. Participants will be randomly assigned to one of three groups:\n\n* Home - Patients will receive BLT at home, following the standard guidelines for light therapy in the Netherlands.\n* LightCafé, fixed time: Patients will receive BLT in a café-like setting called the LightCafé, where the focus is not only on symptom improvement but also lifestyle enhancements and fostering social connections. The treatment time will be the same every day.\n* LightCafé, varying time: Patients will also receive BLT at the LightCafé, with treatment timing varying each day. Additionally, this group will wear glasses in the evening that filter blue light.\n\nThe study includes a baseline phase of up to two weeks, a treatment phase of up to three weeks, and a three-month follow-up phase. Patients will wear a motion watch to assess sleep-wake behaviour and physical activity during the day. Additionally, they will wear a broach that measures their personal light exposure throughout the day. Eight one-minute questionnaires per day will be sent to the participants' smartphones to assess vitality, sleep, and mood during the treatment. Predictors of treatment response, such as clinical characteristics, sleep measures, circadian parameters, and light-related behaviours, will be evaluated at baseline. In a small group of patients, salivary melatonin curves will be assessed before and after treatment. MRI scans will provide insights into functional and structural brain changes following light therapy treatment.",[153,154],"Depression, Unipolar","Depression, Bipolar",[95,156,157,158,159,160,161,162,163,164],"Bright Light Therapy","Chronotherapy","Circadian Rhythm","Sleep","Life Style","Ecological Momentary Assessment","Actigraphy","Dim light melatonin onset","Response predictors","2025-01-07",{"date":167,"type":42},"2025-01-09",{"date":169,"type":42},"2024-02-08",{"date":171,"type":22},"2026-12",{"name":48,"class":49},""]