[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Maastricht University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":237},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,46,75,103,132,162,186,207],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100625009","sex-hormones-impact-on-cannabis-response-100625009",false,"NCT07417059","Sex Hormones Impact on Cannabis Response","The Influence of Female Sex Hormones on the Subjective and Cognitive Response to Cannabis","Inclusion Criteria:\n\n* Biological female\n* Used cannabis between 1 time a month and 2 times a week during the previous year\n* Age between 18 and 40 years\n* Free from psychotropic medication\n* Free from hormonal birth control\n* A regular menstrual cycle (last 3 cycles a duration between 21 and 35 days).\n* Good physical health as determined by medical examination and laboratory analysis\n* Absence of any major medical, endocrine and neurological condition as determined by medical examination and laboratory analysis\n* Normal weight, body mass index (weight\u002Fheight2) between 18 and 28 kg\u002Fm2\n* Written Informed Consent\n* Good knowledge and understanding of the English language\n* Participants must be willing to refrain from taking illicit psychoactive substances during the study.\n* Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drinks after midnight of the evening before the study session, as well as during the study day.\n* Participants must be willing not to drive a traffic vehicle or to operate machines within 24 h after substance administration.\n\nExclusion Criteria:\n\n* History of drug addiction (determined by the medical questionnaire, drug questionnaire and medical examination)\n* Pregnancy or lactation or pregnancy planned during study participation\n* Hypertension (diastolic \\> 90 mmHg; systolic \\> 140 mmHg)\n* Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination)\n* Current presence or history of psychosis in first-degree relatives\n* Any chronic or acute medical condition\n* History of cardiac dysfunctions (arrhythmia, ischemic heart disease,…)\n* Tobacco smoking (\\>20 per day)\n* Excessive drinking (\\>20 alcoholic consumptions per week)",true,"FEMALE","18 Years","40 Years",{"count":21,"type":22},21,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this study is to systematically determine whether the cannabis response in human females is related to SH fluctuations throughout the menstrual cycle.",[28],"Cannabis",[30,31,32],"sex hormones","cannabis","THC","RECRUITING","2026-02-10",{"date":36,"type":37},"2026-02-18","ACTUAL",{"date":39,"type":37},"2025-06-01",{"date":41,"type":22},"2026-12-31",{"name":43,"class":44},"Maastricht University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":16,"sex":53,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":45},"100612855","breathe-hard-to-breathe-easy-online-breathwork-assisted-therapy-for-social-anxiety-100612855","NCT07259005","Breathe Hard to Breathe Easy: Online Breathwork-Assisted Therapy for Social Anxiety","BHBE","Inclusion Criteria:\n\n* Fluent in the English or Dutch language\n* Aged between 18 and 65\n* LSAS score ≥50\n* Written informed consent\n\nExclusion Criteria:\n\n* Hypotension (diastolic \\\u003C 60 mmHg; systolic \\> 90 mmHg) or hypertension (diastolic \\> 90 mmHg; systolic \\> 140 mmHg)\n* History or presence of psychotic or bipolar disorders or first-degree relatives suffering from this\n* History of respiratory or cardiovascular\u002Fheart problems or disease, cerebral aneurysm\n* History of fainting or syncope, epilepsy or seizures\n* History of panic disorder or panic attacks,\n* Having had adverse reactions with prior breathwork sessions (i.e., fainting),\n* Pregnancy, thinking one might be pregnant, trying to get pregnant, or breastfeeding\n* Any problems affecting the ability to pace breathing (i.e., active\u002Fchronic respiratory infection including blocked nose\u002Fcough\u002Fcold\u002Ffever, etc.), breathlessness, abnormally slow breathing (bradypnea), or abnormally fast breathing (tachypnoea), any other physical\u002Fmental health conditions or current life events impairing the ability to engage in activities involving breath control\n* Taking any regular medication other than the contraceptive pill, including medications to reduce blood pressure (i.e., Ramipril or other ACE-inhibitors) and beta-blockers (i.e., Propranolol).","ALL","65 Years",{"count":56,"type":22},96,[25],"This study aims to investigate the potential of supplementing psychotherapy with breathing techniques as a new online therapeutic approach to reduce social anxiety (SA). Clinically significant SA affects a substantial portion of the population (about 13%) and is associated with strong negative feelings of shame and anxiety in social settings. Such emotional distress leads to impairment in personal, relational, and professional functioning and may result in increasing degrees of social isolation.\n\nIn response to the demand for improved treatments for SA, this project aims to explore the efficacy of a novel treatment approach integrating online psychotherapy with online breathwork sessions designed to induce ASC.\n\nWe will recruit 96 individuals with SA, who will be randomly divided into two groups: one group will receive the new combined breathwork-assisted psychotherapy, and the other an active control intervention that does not induce ASC. Over the treatment duration, the effectiveness of these treatments will be closely monitored using established psychological scales and by observing patients in live interactions before and after therapy.\n\nThis project is expected to open the way to a more accessible and effective treatment option for a large group of people struggling with SA. More broadly, the findings will also contribute to our understanding of how ASC, induced through breathing techniques, can be used therapeutically. This could change the way a variety of mental health conditions (e.g., other anxiety-related conditions and depression) are treated, making a substantial impact on public health and the way mental health disorders are approached and managed.",[60],"Social Anxiety",[62,63,64,65,66],"social anxiety","breathwork","psychotherapy","breathwork-assisted psychotherapy","altered states of consciousness","2025-11-21",{"date":69,"type":37},"2025-12-02",{"date":71,"type":37},"2025-04-10",{"date":73,"type":22},"2028-04-10",{"name":43,"class":44},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":54,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100544408","the-impact-of-psilocybin-on-pain-in-fibromyalgia-patients-100544408","NCT06368492","The Impact of Psilocybin on Pain in Fibromyalgia Patients","The Impact of Psilocybin on Pain in Fibromyalgia Patients: a Multicentre Trial.","PsiloFM","Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Normal weight, body mass index (weight\u002Fheight2) between 18 and 28 kg\u002Fm2\n* Fulfilment of the American College of Rheumatology criteria for FM diagnosis (43)\n* A minimum Numeric Rating Scale (numeric rating scale) pain score of 5 out of 10\n* Proficient knowledge of the Dutch or English language\n* Written Informed Consent\n* Understanding the procedures and the risks associated with the study\n* No regular use of psychotropic medication such as opiates, antidepressants, muscle relaxants, anticonvulsants, sleep aids, benzodiazepines. Non pharmacological regimens will be allowed along 1 rescue therapy such as acetaminophen ≤4,000 mg\u002Fday, ibuprofen ≤1,200 mg\u002Fday, naproxen ≤660 mg\u002Fday, or ketoprofen ≤75 mg\u002Fday. Use of paracetamol (PCM) and non-steroidal anti-inflammatory drugs (NSAIDS) will be allowed and monitored.\n* Willingness to refrain from taking psychoactive substances during the study.\n* Willingness to drink only alcohol-free liquids and no coffee, black or green tea, or energy drinks after midnight of the evening before the study session, as well as during the study days\n* Willingness not to drive a traffic vehicle or to operate machines within 24 h after substance administration\n\nExclusion Criteria:\n\n* Presence of any other painful condition such as inflammatory rheumatic diseases, migraines or headaches and of other chronic or acute medical conditions\n* Presence or history of any other psychiatric condition such as primary major depressive disorder, anxiety disorders or substance use disorder as determined by the medical questionnaire, drug questionnaire and medical examination\n* Previous experience of serious side effects to psychedelic drugs (anxiety or panic attacks)\n* Tobacco smoking (\\>20 per day)\n* Excessive drinking (\\>20 alcoholic consumptions per week)\n* Psychotic disorder in first-degree relatives\n* Pregnancy or lactation\n* Hypertension (diastolic \\> 90 mmHg; systolic \\> 140 mmHg)\n* History of cardiac dysfunctions (arrhythmia, ischemic heart disease…)\n* For women: no use of a reliable contraceptive",{"count":84,"type":22},35,[25],"Rationale: Recent evidence shows that Lysergic Acid Diethylamide (LSD), even when administered in low, non-hallucinogenic doses, can produce analgesic effects and improve pain tolerance in a sample of healthy volunteers. Such results complement what was already observed with other serotonergic psychedelics such as psilocybin: survey studies and case series indicate that its use may lead to improvements in chronic pain conditions such as migraines, cluster headaches and phantom limb pain even at low, non-psychedelic doses. These effects have however not yet been investigated and confirmed in clinical populations under controlled experimental conditions.\n\nFibromyalgia (FM) is a chronic condition characterised by widespread pain, hyperalgesia, anxiety, disturbed sleep patterns, impaired cognitive functioning and comorbid mood disorders. Most suggested therapies are only associated with small improvements in pain ratings and quality of life. Currently, there is no data concerning the effectiveness of serotonergic psychedelics in improving pain ratings in fibromyalgia patients.\n\nObjective: The present study will explore the effects that the administration of a placebo and 2 low psilocybin doses (5 mg or 10 mg) will have on pain perception in a group of fibromyalgia patients.\n\nStudy design: The present study uses a double-blind, randomized, placebo-controlled design. All participants will receive a placebo and 2 doses of psilocybin (5 mg or 10 mg) and will undergo the Cold Pressor Test (CPT) and the Pain Pressure Threshold Task (PPT) o test its analgesic effects.",[88],"Fibromyalgia",[90,91,92,93],"fibromyalgia","psychedelics","psilocybin","chronic pain","2025-09-08",{"date":96,"type":37},"2025-09-15",{"date":98,"type":37},"2024-05-03",{"date":100,"type":22},"2025-12",{"name":43,"class":44},2,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":102},"100502669","exploring-novel-biomarkers-for-emphysema-detection-100502669","NCT05825261","Exploring Novel Biomarkers for Emphysema Detection","Exploring Novel Biomarkers for Emphysema Detection: the ENBED Study","ENBED","Inclusion Criteria:\n\n* Adults aged over 18 years\n* current respiratory smptoms (any dyspnea, cough or sputum)\n* spirometry confirmed diagnosis of a non-fully reversible airflow obstruction, defined as a post bronchodilator Forced Expiratory Volume at one second\u002FForced Vital Capacity (FEV1\u002FFVC ratio) \\\u003C 0.7 and\u002For emphysemateus abnormalities on CT imaging.\n* presence of risk factors or causes associated with COPD\n* chest CT scan performed in the past 12 months prior to inclusion to the study\n* able to understand, read and write Dutch language\n\nExclusion Criteria:\n\n* acute exacerbation of COPD within 8 weeks of start of the study\n* comorbidities affecting speech or breathing coordination (neuromuscular disease, CVA\\\u003C BMI \\> 40)\n* comorbidities affecting speech characteristics of dyspnea (severe heart failure, interstitial lung disease)\n* comorbidities affecting respiratory system including but not exclusive to asthma or cystic fibrosis\n* comorbidities that significantly interfere with interpretation of speech (audio signals), such as Parkinson's disease, bulbar palsy, or vocal cord paralysis.\n* Medical history of lobectomy or endoscopic lung volume reduction (ELVR)\n* inability to carry out a capnography recording.\n* investigator's uncertainty about the willingness or ability of the patients to comply with the protocol requirements.\n* participation in another study involving investigational products. Participation in observational studies is allowed.",{"count":112,"type":22},200,"OBSERVATIONAL","The goal of this clinical trial is to evaluate whether voice or capnometry, alone or in combination with other (non invasive) biomarkers can be used to detect emphysema on chest CT-scan in people with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is:\n\n• Can a machine-learning based algorithm be developed that can classify the extent of emphysema on chest CT scan from patients with COPD, based on voice and\u002For capnometry.\n\nParticipants will:\n\n* perform different voice-related tasks\n* perform capnometry twice (before\u002Fafter exercise)\n* perform a light exercise task between tasks ( 5-sit-to-stand test)\n* undergo one venipuncture",[116,117],"Copd","Emphysema",[119,120,121,122,123],"vocal biomarkers","speech","emphysema","capnometry","chest CT","2025-06-10",{"date":126,"type":37},"2025-06-13",{"date":128,"type":37},"2023-09-07",{"date":130,"type":22},"2026-05",{"name":43,"class":44},{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":142,"conditions":143,"keywords":147,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},"100586382","the-dragon-plc-trial-dragon-plc-100586382","NCT06914648","The Dragon PLC Trial (DRAGON-PLC)","The DRAGON PLC Trial - An International Multicenter Randomized Controlled Trial to Compare Combined Portal and Hepatic Vein Embolization (PVE\u002FHVE) With PVE Alone in Primary Liver Cancers.","Inclusion Criteria:\n\n* PLC diagnosis, specifically iCCC, pCCC, and HCC;\n* Requiring PVE due to an FLR volume is \\\u003C30% in normally functioning livers, \\\u003C40% in livers with potentially impaired function e.g. resulting from prior systemic therapy induction or bile duct colonization \u002F transpapillary biliary drainage, or \\\u003C50% in livers with severely impaired function resulting from liver cirrhosis (max. Child Pugh A5) OR function on hepatobiliary scintigraphy (HEBIS) is \\\u003C 2.7 %\u002Fmin\u002Fm2;\n* Age ≥ 18 years;\n* Able to understand the trial and provide informed consent.\n\nExclusion Criteria:\n\n* Liver cirrhosis with a Child-Pugh score of B or C;\n* Presence of portal hypertension;\n* Presence of cholangitis;\n* Pregnant women;\n* Premenopausal females not able\u002Fwilling to commit to contraception (specifically long-acting reversible contraception or hormonal contraception);\n* Patients unresectable due to prohibitive comorbidities (decision made by local multidisciplinary team);\n* Patients with hepatic malignancies other than iCCC, pCCC or HCC;\n* PVE\u002FHVE anatomically not feasible;\n* Any patient with non-resectable or non-ablatable extrahepatic metastatic disease.\n* Unable to understand the study information, study instructions and give informed consent",{"count":140,"type":22},358,[25],"The goal of the DRAGON PLC clinical trial is to determine whether portal vein embolization (PVE) combined with hepatic vein embolization (HVE) improves resectability and overall survival in patients with initially unresectable primary liver cancer compared to standard PVE alone. This trial specifically focuses on patients with hepatocellular carcinoma and cholangiocarcinoma.\n\nThe main questions this trial aims to answer are whether combined PVE and HVE increases the proportion of patients who become resectable within 3 weeks and improves 5-year overall survival compared to PVE alone by enhancing liver hypertrophy.\n\nParticipants will:\n\n* Undergo either standard PVE or combined PVE and HVE.\n* Have regular imaging to assess liver resectability.\n* Be monitored for survival outcomes up to 5 years after intervention.",[144,145,146],"Primary Liver Cancer","Hepatocellular Carcinoma (HCC)","Cholangiocarcinoma",[148,149,150,151,152],"Primary liver cancer","Future Liver Remnant","Liver regeneration","Portal Vein Embolization (PVE)","Hepatic Vein Embolization (HVE)","2025-05-12",{"date":155,"type":37},"2025-05-15",{"date":157,"type":37},"2025-04-01",{"date":159,"type":22},"2032-11-15",{"name":43,"class":44},55,{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":23,"phases":172,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},"100472196","the-dragon-2-trial-100472196","NCT05428735","The DRAGON 2 Trial","An International Multicenter Randomized Controlled Trial to Compare Combined Portal and Hepatic Vein Embolization (PVE\u002FHVE) with PVE Alone in Patients with Colorectal Liver Cancer Metastases (CRLM) and a Small Future Liver Remnant (FLR)","DRAGON 2","Inclusion Criteria:\n\n* Patients with primarily unresectable\u002F potentially resectable CRLM with a FLR \\\u003C30% (\\\u003C40% in chemotherapy damaged livers)\n* Patients with non-resected primary CRC may be included if there is an intention to resect the CRC after the liver treatment (liver first approach) or simultaneously during one of the liver procedures.\n* Patients with resectable or ablatable lung or brain metastases can be included (statement about the resectability of these extrahepatic metastases by a tumor board needs to be available)\n* 18 Years and older\n* Men and women\n* Able to understand the trial and provide informed consent.\n\nExclusion Criteria:\n\n* Pregnant or lactating female.\n* Premenopausal females not able or willing to commit to oral contraception\n* Patients with prohibitive comorbidities, decision made by local team\n* Any patient with non-resectable or non-ablatable extrahepatic disease\n* Patients with hepatic malignancies other than CRLM\n* Progression of disease by RECIST criteria after cytoreduction chemotherapy\n* Complete response after conversion chemotherapy\n* Staging CT and (if indicated) CT\u002FMRI brain that demonstrates non-resectable extrahepatic disease\n* The anatomy of the liver or manifestation of tumors in relation to the liver veins prohibits the use of combined PVE\u002FHVE.",{"count":171,"type":22},348,[25],"In the randomized controlled DRAGON 2 trial study subjects will be randomized between two arms, PVE alone (control group) and PVE\u002FHVE (interventional group).",[175,176],"Colorectal Cancer Liver Metastases (CRLM)","Small Future Liver Remnant (FLR)","2024-10-29",{"date":179,"type":37},"2024-11-01",{"date":181,"type":37},"2022-04-01",{"date":183,"type":22},"2029-06-30",{"name":43,"class":44},24,{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":45},"100454607","mtdna-mutation-load-analysis-in-mesoangioblasts-100454607","NCT05199740","mtDNA Mutation Load Analysis in Mesoangioblasts","Assess the mtDNA Mutation Load in Mesoangioblasts of mtDNA Mutation Carriers","MABS05","Inclusion Criteria all participants:\n\n* Written informed consent\n* Age: 18+\n* Sex: male\u002Ffemale\n* Carriers of a heteroplasmic mtDNA mutation load \\>20% in skeletal muscle or \\>1% in blood\n\nExclusion Criteria all participants:\n\n* No informed consent\n* Use of anti-coagulants, anti-thrombotics and other medication influencing coagulation\n* Have a weekly alcohol intake of ≥ 35 units (men) or ≥ 24 units (women)\n* Current history of drug abuse\n* A history of strokes\n* Significant concurrent illness\n* Ongoing participation in other clinical trials that contain an intervention\n* Major surgery within 4 weeks of the visit\n* Pregnant or lactating women\n* Patients unable and\u002For unwilling to comply with treatment and study instructions",{"count":195,"type":22},30,"Mitochondrial diseases caused by defects in oxidative phosphorylation (OXPHOS) due to heteroplasmic mitochondrial DNA (mtDNA) mutations are rare (frequency 1\u002F5,000), but severe multi-system disorders. Clinical manifestations are highly variable, but predominantly affect energy demanding tissues, like brain and muscle. Myopathy is a common feature of mtDNA disorders, being present in more than 50% of the mtDNA mutation carriers, and seriously affects patients' general well-being and quality of life. Currently, no treatment is available for these patients, although the induction of muscle regeneration by exercise treatment has been shown to alleviate their myopathy. This implies that these patients can produce muscle fibres that perform better, most likely because the mutation load is lower. Mesoangioblasts (MABs) are myogenic precursors that have been recognized as a source for development of a systemic myogenic stem-cell therapy. Autologous MABs may be feasible for half of the mtDNA mutation carriers of 6 different mtDNA mutations, as their mtDNA mutation load in mesoangioblasts was (nearly) absent (\\\u003C10%). However, there are many more mtDNA mutations in the 16.5kb mtDNA and the aim of this study is to determine the mtDNA mutation load in mesoangioblasts of other mtDNA mutation carriers and identify the patients or mutations for which this is a feasible approach.",[198],"Mitochondrial Myopathies","2024-01-22",{"date":201,"type":37},"2024-01-24",{"date":203,"type":37},"2022-12-20",{"date":205,"type":22},"2026-07-01",{"name":43,"class":44},{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":53,"minAge":213,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":23,"phases":216,"briefSummary":217,"conditions":218,"keywords":223,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},"100501722","clinical-and-cost-effectiveness-of-group-schema-therapy-for-complex-eating-disorders-the-gst-eat-study-100501722","NCT05812950","Clinical and Cost-effectiveness of Group Schema Therapy for Complex Eating Disorders: the GST-EAT Study","Inclusion Criteria:\n\n* 1\\) age \\> 16 years;\n* 2\\) a DSM-5 diagnosis of anorexia nervosa, bulimia nervosa, or other specified ED (atypical anorexia nervosa or bulimia nervosa with a low frequency or limited duration).\n\nExclusion Criteria:\n\n* 1\\) not being able to speak and read the Dutch language;\n* 2\\) being in an acute psychotic mental health state at the start of the study;\n* 3\\) being diagnosed with an autism spectrum disorder;\n* 4\\) having an IQ below 80, as determined with a validated instrument;\n* 5\\) showing an early response after phase 1 of CBT-E.","16 Years",{"count":215,"type":22},230,[25],"Amongst psychiatric illnesses, eating disorders (EDs) are notoriously difficult to treat and have a high mortality rate. The average duration of an ED is 6 years and for a majority of ED patients, the disorder will become chronic. Comorbid personality pathology such as negative core beliefs and early maladaptive schemas (EMS) are strongly related to ED severity and chronicity. Enhanced cognitive-behavioural therapy for eating disorders (CBT-E) is used as the first line transdiagnostic treatment for EDs. However, CBT-E is mainly symptom-focused and does not tap into these underlying core beliefs and EMS.\n\nGiven the limited treatment effects of existing ED treatments, and the importance of comorbid personality pathology, there is an urgent need to examine more effective treatments for EDs. Group-schematherapy (GST) overcomes the limitations of CBT-E and preliminary results for treatment-resistant EDs are promising. However, robust evidence regarding the clinical and cost-effectiveness of GST for patients that do not benefit from CBT-E is not yet available. The central aim of this project is to investigate the clinical and cost-effectiveness of GST for EDs in patients with comorbid personality pathology, who do not show a clinically significant response in the first phase of CBT-E. This is relevant and important as studies examining the effectiveness of GST for EDs are scarce. This project is a joint research initiative of three academic centers (Dutch Universities), four large nation-wide mental health organizations, and two foundations for client empowerment and participation. Eligible patients will be randomized to either GST or continuation of their CBT-E treatment after failing to show a significant treatment response in the first phase of CBT-E. Based on encouraging findings from previous studies and our own pilot data, a statistically and clinically significant better outcome in terms of ED symptoms, negative core beliefs, EMS, schema modes, and quality of life is expected in the GST group compared to the CBT-E group. GST is also expected to be more cost-effective compared to CBT-E as GST may in the long run prevent chronicity in terms of long treatment trajectories and delayed recovery. Finally, with the proviso of good results for GST, we will disseminate and implement GST in the standard of care for EDs. This project thereby has great potential to improve clinical and cost-effectiveness of treatment for chronic EDs.",[219,220,221,222],"Anorexia Nervosa","Atypical Anorexia Nervosa (Other Specified Eating Disorder)","Bulimia Nervosa","Atypical Bulimia Nervosa (Other Specified Eating Disorder)",[224,225,226,227],"CBT-E","Group Schema Therapy","Eating disorders","Effectiveness","2023-11-27",{"date":230,"type":37},"2023-11-30",{"date":232,"type":37},"2023-07-24",{"date":234,"type":22},"2026-12",{"name":43,"class":44},7,""]