[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"generalized-anxiety-disorder-gad\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:generalized-anxiety-disorder-gad":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,51,78,111,136,157,179,207,231,255,292,319,346,390,419,452,473,500,533,563,588,605,634],{"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":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100625972","transcranial-alternating-current-stimulation-for-generalized-anxiety-disorder-and-insomnia-an-open-label-pilot-study-100625972",false,"NCT07429578","Transcranial Alternating Current Stimulation for Generalized Anxiety Disorder and Insomnia: An Open-Label Pilot Study","Transcranial Alternating Current Stimulation for the Treatment of Anxiety and Insomnia: An Open-Label Pilot Clinical Trial","NewWaves","Inclusion Criteria:\n\nAge between 18 and 65 years; Diagnosis of Generalized Anxiety Disorder (GAD) based on Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria; Diagnosis of chronic primary insomnia; Hamilton Anxiety Rating Scale (HAM-A) score ≥15 at screening, indicating at least moderate anxiety severity; Score \\>5 on the Pittsburgh Sleep Quality Index (PSQI); Stable use of antidepressants (SSRI or SNRI) is allowed; Limited use of benzodiazepines (maximum of 10 mg\u002Fday diazepam equivalent).\n\nExclusion Criteria:\n\nHistory of mania, hypomania, or bipolar disorder; Contraindications to the use of transcranial stimulation; Active suicidal ideation or suicide attempt in the last 4 weeks; Refractoriness to 3 or more antidepressant treatments; Pregnancy; Other psychiatric diagnoses (e.g., schizophrenia, substance dependence, major depressive disorder); Severe medical or neurological conditions; Anxiety or insomnia secondary to other medical or psychiatric conditions (e.g., hypothyroidism, anemia).","ALL","18 Years","65 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"NA","This is an open-label pilot clinical trial to evaluate the effects of transcranial alternating current stimulation (tACS) in adults diagnosed with generalized anxiety disorder (GAD) and chronic primary insomnia. The study will involve 30 participants who will receive 20 sessions of tACS over four weeks. The stimulation will be delivered at 15 mA and 77.5 Hz using the Nexalin device. The main goal is to assess improvements in anxiety and sleep quality. Results from this study will provide preliminary evidence for future randomized controlled trials.",[28,29],"Generalized Anxiety Disorder (GAD)","Chronic Insomnia",[31,32,33,34,35,36,37],"tACS","Neuromodulation","Non-invasive brain stimulation","Sleep disorders","Anxiety treatment","Transcranial alternating current stimulation","Generalized Anxiety Disorder","RECRUITING","2026-06-19",{"date":41,"type":42},"2026-06-23","ACTUAL",{"date":44,"type":42},"2025-06-01",{"date":46,"type":22},"2026-07-31",{"name":48,"class":49},"University of Sao Paulo","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100581131","phase-2-study-to-assess-adverse-events-and-change-in-disease-activity-when-oral-abbv-932-is-added-to-antidepressant-therapies-in-adult-participants-with-generalized-anxiety-disorder-100581131","NCT06846320","Study to Assess Adverse Events and Change in Disease Activity When Oral ABBV-932 is Added to Antidepressant Therapies in Adult Participants With Generalized Anxiety Disorder","A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose Study to Evaluate the Efficacy, Safety, and Tolerability of ABBV-932 as an Adjunct to Antidepressant Therapies in the Treatment of Subjects With Generalized Anxiety Disorder Who Have Had an Inadequate Response to Antidepressant Therapies","Inclusion Criteria:\n\n* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for generalized anxiety disorder (GAD) confirmed by the Mini International Neuropsychiatric Interview (MINI).\n* Currently taking protocol-specified antidepressant therapies (ADT) for GAD with an inadequate response to an adequate dose (per label) and duration (\\>= 8 weeks) as verified by a baseline Hamilton Anxiety Rating Scale (HAM-A) total score \\>= 20 and Clinical Global Impression of Severity Scale (CGI-S GAD) \\>= 4.\n\nExclusion Criteria:\n\n* Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score \\>= 20.\n* New diagnosis or exacerbation of major depression in the last 6 months.",{"count":59,"type":22},315,[61],"PHASE2","Generalized anxiety disorder (GAD) is usually treated with antidepressant therapy (ADT); however, sometimes ADTs alone are not enough to adequately treat GAD. The purpose of this study is to assess how safe and effective ABBV-932 is when added to the antidepressant therapies in adult participants with GAD who have had an inadequate response ADTs.\n\nABBV-932 is an investigational drug being developed for the adjunctive treatment of GAD. Participants will be randomly assigned to receive ABBV-932 or Placebo in addition to their currently prescribed ADTs. There is 1 in 3 chance of participants assigned to Placebo. Approximately 315 adult participants with GAD and inadequate response to ADTs will be enrolled in approximately 50 sites in the United States and Puerto Rico.\n\nParticipants will receive oral capsules of ABBV-932 or matching placebo in addition to their prescribed ADT for 6 weeks and then will be followed for an additional 4 week follow-up period.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[28],[65,28,66],"LEGATO - (GAD)","ABBV-932","2026-06-15",{"date":69,"type":42},"2026-06-17",{"date":71,"type":42},"2025-04-29",{"date":73,"type":22},"2026-11",{"name":75,"class":76},"AbbVie","INDUSTRY",52,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":50},"100642718","transcranial-alternating-current-stimulation-to-enhance-mindfulness-therapy-in-generalized-anxiety-disorder-100642718","NCT07648797","Transcranial Alternating Current Stimulation to Enhance Mindfulness Therapy in Generalized Anxiety Disorder","Effects and Mechanisms of Individualized Alpha-Frequency Transcranial Alternating Current Stimulation as an Augmentation Strategy for Mindfulness Therapy in Patients With Generalized Anxiety Disorder","Inclusion Criteria:\n\n* Outpatients or inpatients of The Second Xiangya Hospital of Central South University.\n* Diagnosis of generalized anxiety disorder as the primary diagnosis according to the International Classification of Diseases 11th Revision (ICD-11) diagnostic criteria, confirmed by two experienced psychiatrists.\n* Hamilton Anxiety Rating Scale (HAMA) total score of 14 or higher.\n* Aged 18 to 60 years, inclusive.\n* Right-handed.\n* Junior high school education or above, with sufficient ability to understand the study procedures, complete informed consent, clinical scales, and cognitive assessments.\n* Currently not using anxiolytic or antidepressant medications, or receiving a stable medication regimen for at least 1 month before enrollment, with no planned changes in the medication regimen during the 2-week treatment period unless clinically necessary.\n* Voluntarily agrees to participate in the study, signs the informed consent form, and is able to comply with study visits, treatment procedures, laboratory examinations, and other study requirements.\n\nExclusion Criteria:\n\n* Presence of psychotic symptoms.\n* Meeting ICD-11 diagnostic criteria for schizophrenia or other primary psychotic disorders, bipolar or related disorders, current depressive episode, dysthymic disorder, or post-traumatic stress disorder currently or within the past year.\n* Organic brain disease or severe physical illness, including but not limited to thyroid disease, systemic lupus erythematosus, diabetes, severe pulmonary, hepatic, or renal impairment, infection, or major trauma.\n* Clinically significant uncorrectable sensory impairment, such as hearing impairment that prevents effective communication.\n* Pregnancy or lactation.\n* Contraindications to transcranial electrical stimulation or related procedures, including metal implants in the body, intracranial hypertension, skull defects, brain tumor, severe heart disease, unstable vital signs due to serious physical illness, acute cerebrovascular disease, or a history of adverse reactions to electrical stimulation.\n* Any other condition that, in the investigator's judgment, makes the participant unsuitable for this study.","60 Years",{"count":87,"type":22},99,[25],"This randomized, double-blind, sham-controlled clinical trial will evaluate whether individualized alpha-frequency transcranial alternating current stimulation (tACS) can enhance the effects of mindfulness therapy in adults with generalized anxiety disorder. A total of 99 participants will be randomly assigned to one of three groups: synchronous tACS combined with mindfulness therapy, desynchronous tACS combined with mindfulness therapy, or sham tACS combined with mindfulness therapy.\n\nAll participants will receive a standardized mindfulness therapy program. The study will compare changes in anxiety symptoms, worry, mindfulness, attention control, cognitive performance, and neurophysiological measures across the three groups. Assessments will be conducted from baseline through follow-up visits to examine both clinical effects and possible neural mechanisms.",[28],[92,31,93,94,95,96,97,98,99,100],"Transcranial Alternating Current Stimulation","Mindfulness Therapy","Mindfulness Meditation","Individualized Alpha Frequency","Frontoparietal Network","Dorsolateral Prefrontal Cortex","Inferior Parietal Lobule","Worry","Executive Attention","NOT_YET_RECRUITING","2026-06-12",{"date":104,"type":42},"2026-06-16",{"date":106,"type":22},"2026-06-01",{"date":108,"type":22},"2028-06-01",{"name":110,"class":49},"Central South University",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":121,"conditions":122,"keywords":123,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":4},"100642913","mri-guided-accelerated-ctbs-for-generalized-anxiety-disorder-100642913","NCT07640945","MRI-Guided Accelerated cTBS for Generalized Anxiety Disorder","Efficacy and Neural Mechanisms of MRI-Guided Accelerated Continuous Theta Burst Stimulation Targeting the Inferior Parietal Lobule in Generalized Anxiety Disorder: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Outpatients or inpatients at the Second Xiangya Hospital who are confirmed by two experienced psychiatrists to meet the International Classification of Diseases 11th Revision (ICD-11) diagnostic criteria for generalized anxiety disorder.\n* Aged 18 to 65 years, regardless of gender.\n* Right-handed.\n* Junior high school education or above, with the ability to provide informed consent and complete cognitive assessments.\n* Able to receive anti-anxiety treatment during the follow-up period according to the instructions of outpatient or inpatient physicians.\n* Hamilton Anxiety Rating Scale (HAMA) score ≥14 and Patient Health Questionnaire-15 (PHQ-15) score ≥5.\n\nExclusion Criteria:\n\n* Presence of psychotic symptoms.\n* Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, current psychiatric symptoms, or post-traumatic stress disorder based on SCID-5 assessment, either currently or within the past year.\n* Organic brain disease or severe somatic diseases, such as thyroid disease, lupus, diabetes, lung disease, liver disease, kidney disease, infection, or major trauma.\n* Intracranial implants.\n* Clinically significant sensory impairments that cannot be corrected, such as color blindness or hearing impairment.\n* Pregnant or breastfeeding women.\n* Positive urine drug screen.\n* Abnormal thyroid function tests.\n* Personal history of epilepsy or family history of epilepsy.\n* Receipt of physical therapy within the past six months, such as repetitive transcranial magnetic stimulation or electroconvulsive therapy.\n* Suspected or confirmed history of alcohol or drug dependence.\n* Use of anticoagulants, such as heparin or warfarin, corticosteroids, or thyroid disease treatments within the past three months.\n* Current use of psychoactive medications.\n* Receipt of neurocognitive assessments similar to those used in this study within the past 12 months.",{"count":119,"type":22},75,[25],"Generalized Anxiety Disorder (GAD) is a common psychiatric disorder associated with persistent anxiety, functional impairment, and incomplete response to existing treatments. Although transcranial magnetic stimulation (TMS) has shown therapeutic potential in anxiety disorders, conventional treatment schedules often require several weeks and may not provide sufficiently rapid symptom relief. This study aims to evaluate the efficacy and safety of precision-targeted accelerated continuous theta-burst stimulation (cTBS) guided by individualized functional connectivity between the intraparietal sulcus (IPS) and the amygdala in patients with GAD.",[28],[28,124,125,126,33,32,127],"transcranial magnetic stimulation","Single-center","Randomized Controlled Trial","theta burst stimulation","2026-06-09",{"date":130,"type":42},"2026-06-11",{"date":132,"type":22},"2026-06",{"date":134,"type":22},"2027-02",{"name":110,"class":49},{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":23,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":50},"100626066","personalized-ai-driven-models-in-cognitive-behavioral-therapy-for-anxiety-100626066","NCT07430800","Personalized AI-Driven Models in Cognitive Behavioral Therapy for Anxiety","SCH: Personalized AI-Driven Models for Supporting User Engagement and Adherence in Health Interventions: Validation in Cognitive Behavioral Therapy for Anxiety","Inclusion Criteria:\n\n* Are 18 years of age or older\n* Are university students\n* Are able to communicate in English\n* Have corrected-to-normal vision and hearing\n* Consent to have audio\u002Fvideo\u002Finteraction data recorded as part of the study\n* Have a GAD-7 (Generalized Anxiety Disorder-7 item) score of 5 or greater, indicating mild to elevated levels of self-reported symptoms of anxiety\n* Have a lower than minimal level of suicidality risk as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) during screening (\"NO\" responses to items 3, 4, 5, and 6 on C-SSRS)\n* Having access to home WiFi\n\nExclusion Criteria:\n\n* Are less than 18 years of age\n* Are not university students\n* Are not able to communicate in English\n* Do not have corrected-to-normal vision and hearing\n* Do not consent to have audio\u002Fvideo\u002Finteraction data recorded as part of the study\n* Have a GAD-7 (Generalized Anxiety Disorder-7 item) score of 4 or lower.\n* Higher than a minimal level of suicidality risk as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) during screening (\"YES\" responses to items 3, 4, 5, or 6 on C-SSRS)\n* Don't have access to home WiFi",{"count":144,"type":22},140,[25],"Untreated anxiety undermines long-term physical and emotional wellbeing, especially among college students, with rates worsening since the onset of the COVID-19 pandemic. Cognitive Behavioral Therapy (CBT) is the leading evidence-based intervention for anxiety, but many students fail to complete exercises between CBT sessions, reducing its effectiveness. Socially assistive robots (SARs) help promote adherence to home-based practice in the context of elder care, social skill learning, and physical therapy, but it is unknown how SARs can enhance CBT. The specific objective of this research is to develop personalized CBT SARs that can support CBT compliance for college students with anxiety. To meet the goals of the proposed work, these studies will determine how SAR personalization based on implicit and explicit feedback can help promote greater CBT compliance and anxiety reduction outcomes for students.",[28],"2026-06-04",{"date":150,"type":42},"2026-06-08",{"date":152,"type":42},"2026-03-30",{"date":154,"type":22},"2028-08-15",{"name":156,"class":49},"University of Southern California",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":17,"minAge":164,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":23,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":175,"leadSponsor":177,"locationsCount":4},"100638602","ai-supported-therapy-for-depression-and-anxiety-compared-with-standard-cbt-100638602","NCT07620340","AI-Supported Therapy for Depression and Anxiety Compared With Standard CBT","Evaluating the Efficacy of an AI Delivered, Neurosymbolic, Human Supervised Digital Intervention for Depression and Anxiety Versus Standard Cognitive Behavioural Therapy in Young Persons and Adults","Inclusion Criteria:\n\n* Have symptoms of Generalized Anxiety Disorder (GAD) and\u002For symptoms of --•Major Depressive Disorder (MDD) as the primary reason for seeking treatment (formal diagnosis not required).(as determined by a Psychological Well-being Practitioner).\n* Meet symptom-severity criteria on either validated screening measure:\n* Depression: PHQ-9 (or PHQ-A for young persons) total score between 10 and 19, corresponding to moderate to moderately-severe symptoms, and\u002For\n* Anxiety: GAD-7 total score between 8 and 21, corresponding to mild to severe symptoms.\n* Aged 16-64 years\n* If taking psychotropic medication for depression and\u002For anxiety, be on a stable regimen for at least 6 weeks prior to screening, with no initiation, discontinuation, or dose change during that period.\n* Have reliable access to a compatible, internet-connected device and are able to use it for screening\u002Feligibility, and the intervention and assessments (any potential costs to participants will be clearly noted in the PIS).\n* Possess sufficient English language proficiency and cognitive capacity to engage with the digital therapeutic content and complete questionnaires.\n* Provide informed consent.\n* Willing to be randomised and to participate in a clinically-supervised CBT-based AI programme, including completion of scheduled outcome assessments.\n\nExclusion Criteria:\n\n* Depression: PHQ-9 (or PHQ-A for young persons) total score \\>≥ 20\n* Present with a primary or comorbid diagnosis (or history of) that is unsuitable for a digital CBT-based intervention (as judged by the Investigator), including:\n* Post-traumatic stress disorder (PTSD) or complex trauma\n* Psychotic disorder, bipolar disorder, and\u002For mania\n* Complex or treatment-resistant obsessive-compulsive disorder (OCD)\n* Personality disorder\n* Eating disorder\n* Substance or alcohol use disorder\n* Exhibit high-risk clinical concerns, including:\n* Current suicidal ideation with intent or plan (as indicated by PHQ-9 score and\u002For participant disclosure)\n* Suicide attempt within the past 12 months\n* Ongoing self-harming behaviours\n* Requirement for urgent or crisis mental-health intervention (as indicated by •PHQ-9 score and\u002For participant disclosure)\n* In participants aged 25 years and under, current treatment with an antidepressant medication initiated or dose-adjusted within the past 12 weeks (due to the recognised","16 Years","64 Years",{"count":167,"type":22},400,[25],"This study is a pivotal, randomised, controlled, non-inferiority trial evaluating \"Nook,\" an AI-delivered, neurosymbolic, clinician-supervised digital psychological intervention for depression and anxiety, compared with standard cognitive behavioural therapy (CBT). The trial will recruit 400 participants aged 16-64 years in the UK with moderate depression and\u002For anxiety symptoms. Participants will be randomised to receive either Nook or therapist-delivered CBT.\n\nThe primary objective is to determine whether Nook is non-inferior to CBT in reducing depression and anxiety symptoms, measured using the PHQ-9\u002FPHQ-A and GAD-7 scales. Secondary outcomes include quality of life, functional impairment, sleep quality, treatment engagement, participant satisfaction, safety outcomes, and exploratory health economic measures.\n\nThe intervention incorporates clinician oversight and predefined escalation pathways for suicidality and clinical deterioration. Outcomes will be analysed using longitudinal mixed-effects models under an intention-to-treat framework.",[28,171],"Major Depressive Disorder (MDD)","2026-06-02",{"date":148,"type":42},{"date":106,"type":22},{"date":176,"type":22},"2027-01-07",{"name":178,"class":76},"PsyScale",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":186,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":189,"phases":4,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":50},"100639204","validation-of-the-cidi-50-against-the-scid-5-for-lifetime-mental-disorders-100639204","NCT07604753","Validation of the CIDI 5.0 Against the SCID-5 for Lifetime Mental Disorders","Validity of the World Health Organization CIDI 5.0 for Assessing Lifetime Prevalence of Mental Disorders: A Clinical Reappraisal Study Using the SCID-5","Inclusion Criteria:\n\n* All household members aged 18 years old and over are randomly sampled from the Census and Statistics Department List of Quarters\n* Live in the address sampled from the Census and Statistics Department List of Quarters\n* Reside in Hong Kong for at least six months in the past year\n* Able to read and communicate in Chinese or English\n* Without linguistic or cognitive difficulties\n\nExclusion Criteria:\n\n* Domestic workers",true,{"count":188,"type":22},300,"OBSERVATIONAL","The World Health Organization Composite International Diagnostic Interview (CIDI) is a fully structured diagnostic tool designed for lay interviewers to assess the prevalence of mental and substance use disorders. Earlier versions, such as the CIDI 3.0, demonstrated acceptable individual-level concordance with clinical assessments based on DSM-IV criteria (Haro et al. 2006). The latest iteration (CIDI 5.0) has been updated to operationalize DSM-5 criteria.\n\nRecent evidence from a large-scale, community-based national study in Qatar suggests that under DSM-5 criteria (Khaled et al. 2024), after recalibration, the CIDI 5.0 maintains high specificity (91.9% for MDD, 94.7% for GAD, and 85.5% for PTSD). Sensitivity suggested CIDI diagnoses aligned closely with clinical \"gold standard\" diagnoses (51.5% for MDD, 50.7% for GAD, and 77.3% for PTSD). Despite the evidence from Qatar, there remains a lack of evidence regarding the validity of the CIDI 5.0 in population-based studies.\n\nTherefore, this study aims to evaluate the diagnostic validity of the CIDI 5.0 for Lifetime MDD, GAD, and PTSD, using the Structured Clinical Interview for DSM-5 (SCID-5) as the definitive clinical gold standard.",[171,28,192],"Posttraumatic Stress Disorder (PTSD)",[194,195,196,197],"CIDI","Lifetime prevalence","Mental disorders","Clinical validation","2026-05-19",{"date":200,"type":42},"2026-05-22",{"date":202,"type":42},"2025-05-14",{"date":204,"type":22},"2028-01",{"name":206,"class":49},"The University of Hong Kong",{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":17,"minAge":214,"maxAge":85,"enrollmentInfo":215,"targetDuration":4,"studyType":189,"phases":4,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":229,"locationsCount":50},"100618288","an-examination-of-the-performance-of-qbmobile-in-differential-diagnosis-associated-with-adhd-symptoms-100618288","NCT07329673","An Examination of the Performance of QbMobile in Differential Diagnosis Associated With ADHD Symptoms","An Examination of the Performance of QbMobile in Differential Diagnosis Associated With ADHD Symptoms.","Inclusion Criteria:\n\n* Provide written informed consent (including parent\u002Flegal guardians consent when this is required for individuals under 18 years old and assent as is required based on the age of participant) for QbMobile;\n* Aged \\> 6 years and \\\u003C 60 years old;\n* Referred for an initial assessment for ASD, MDD, Bipolar Disorder or Anxiety Disorder (Separation Anxiety Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder (GAD)) or has a prior diagnosis of one of the included disorders but is not currently receiving treatment;\n* Meets DSM-5 or ICD-11 criteria for a primary diagnosis of ASD, MDD, Bipolar Disorder or Anxiety Disorder per sites standard clinical procedures;\n* Have adequate sensory and physical ability to complete QbMobile;\n* Possess or have access to an iPhone model that supports QbMobile.\n\nExclusion Criteria:\n\n* Intellectual disability designated by IQ\\\u003C70;\n* Has a DSM-5 or ICD-11 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder due to another medical condition, PTSD, antisocial personality disorder, or borderline personality disorder;\n* Has a primary diagnosis of ADHD (combined, inattentive, or hyperactivity\u002Fimpulsive presentation);\n* Has a concurrent medical diagnosis that could significantly affect test performance such as brain injuries, Parkinson's disease, current epilepsy or active seizures, amyotrophic lateral sclerosis (ALS), multiple sclerosis, dementias (e.g. vascular dementia, Alzheimer disease, etc);\n* Has other conditions that could affect test performance (migraine or other types of severe headache, chronic or acute pain);\n* Use of prescription medications (e.g., anxiolytics, sedative medications) taken on the day before completing QbMobile that could significantly affect performance;\n* Substance use (e.g., alcohol, drugs) that may affect performance on the day of the tests.","6 Years",{"count":188,"type":22},"The purpose of this study is to evaluate QbMobile's ability to collect objective data to identify specific symptom profiles in differential diagnoses (ASD, MDD, Bipolar Disorder and Anxiety Disorder) that are common with ADHD.",[218,219,220,221,222,28],"Bi-Polar Disorder","Autism Spectrum Disorder (ASD)","Major Depression Disorders","Separation Anxiety Disorder","Social Anxiety Disorder","2026-05-04",{"date":225,"type":42},"2026-05-06",{"date":227,"type":42},"2026-01-01",{"date":73,"type":22},{"name":230,"class":76},"Qbtech AB",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":238,"targetDuration":4,"studyType":23,"phases":239,"briefSummary":240,"conditions":241,"keywords":244,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":253,"locationsCount":50},"100623006","text-message-safety-behavior-fading-for-pathological-worry-100623006","NCT07391020","Text Message Safety Behavior Fading for Pathological Worry","Safety Behavior Fading Intervention for Pathological Worry","Inclusion Criteria:\n\n\\- Elevated worry as defined by a score of 60 or higher on the PSWQ.\n\nExclusion Criteria:\n\n* Score of 59 or lower on the PSWQ\n* If applicable, unstable psychiatric medication usage any time over the past 4 weeks\n* Failing attention checks in baseline data collection\n* Pregnancy",{"count":188,"type":22},[25],"The current study aims to explore the efficacy of a text message-based Safety Behavior Fading Intervention compared to a PMR control condition.",[28,242,243],"Worrying","Anxiety",[245,246],"safety behaviors","worry","2026-04-28",{"date":249,"type":42},"2026-04-30",{"date":251,"type":42},"2026-03-01",{"date":134,"type":22},{"name":254,"class":49},"Florida State University",{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":263,"enrollmentInfo":264,"targetDuration":4,"studyType":23,"phases":266,"briefSummary":267,"conditions":268,"keywords":275,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":50},"100531301","targeting-social-function-in-anxiety-and-eating-disorders-100531301","NCT06198023","Targeting Social Function in Anxiety and Eating Disorders","Targeting Social Function to Improve Outcomes in Anxiety and Eating Disorders","SF","Inclusion Criteria:\n\n* In the past 12 months, has met DSM-5 criteria met for an eating disorder (Anorexia Nervosa, Atypical Anorexia Nervosa, Bulimia Nervosa, Avoidant-Restrictive Food Intake Disorder, or Other Specified Feeding or Eating Disorder) and\u002For an anxiety disorder (Generalized Anxiety Disorder, Social Anxiety Disorder)\n* Between the ages of 18-30\n\nExclusion Criteria:\n\n* Current inpatient or residential treatment\n* Medical instability or safety\u002Fsuicide risk as determined by the PI","30 Years",{"count":265,"type":22},60,[25],"Social processing and cognition are often altered in patients with eating disorders. The goal of this clinical trial is to assess two different social therapeutic interventions -- one educational, one interactive -- for their effectiveness in improving clinical outcomes in patients with eating disorders. Patients in both interventions will receive education about social function in eating disorders, but those in the interactive treatment group will complete an additional collaborative art task.\n\nParticipants will:\n\n* attend a baseline study visit to complete clinical interviews, cognitive testing, and behavioral tasks\n* complete a pre-intervention assessment with questionnaires\n* attend eight sessions of their assigned treatment group over the course of 12 weeks\n* complete three virtual follow-up assessments 4, 8, and 12 months from their baseline\n* attend a final study visit to repeat some clinical interviews, cognitive testing, and behavioral tasks\n\nResearchers will compare changes in eating disorder, mood, and anxiety symptoms as well as test results from baseline and final study visits for each group to see if\n\n* patients can be treated effectively with education alone or if an interactive group component produces additional benefits\n* cognitive and behavioral task performance are associated with recovery or illness state.",[269,270,271,272,273,274,222,28],"Eating Disorders","Anorexia Nervosa","Bulimia Nervosa","Atypical Anorexia Nervosa","Purging (Eating Disorders)","Other Specified Feeding or Eating Disorder",[276,277,278,279,280,281,282,283],"social function","social cognition","social processing","psychoeducation","group therapy","group intervention","art therapy","social anxiety",{"date":285,"type":42},"2026-05-05",{"date":287,"type":42},"2024-02-28",{"date":289,"type":22},"2028-09",{"name":291,"class":49},"University of Texas Southwestern Medical Center",{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":23,"phases":301,"briefSummary":302,"conditions":303,"keywords":305,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":315,"leadSponsor":317,"locationsCount":4},"100634573","miles-for-mental-health-100634573","NCT07541443","Miles for Mental Health","Miles for Mental Health: The Impact of Cardiovascular Fitness on Mental Health Outcomes","Inclusion Criteria:\n\n* Age 18+ years\n* Generalized anxiety and\u002For depressive disorder diagnosis\n* Able to exercise without use of ambulatory device\n* Willing and able to attend a minimum of 2 group exercise sessions weekly\n\nExclusion Criteria:\n\n* Myocardial infarction or symptoms of coronary artery disease in the last 2yrs\n* Uncontrolled hypertension within the last 6 months\n* Cancer in the last 2yrs (except non-metastatic basal or squamous cell carcinoma)\n* Significant pain or musculoskeletal disorder that would prohibit participation in an exercise program\n* Possible\u002Fprobably dementia or mild cognitive impairment (MCI) base on adjudication\n* Physician concern regarding safety or completion of the study",{"count":300,"type":22},20,[25],"Common mental health disorders, like anxiety and depression, are widespread among the American population. The prevalence of mental health disorders among adults continues has consistently increased from previous decades and is now a major public health challenge. Data shows that 1 in 5 Americans regularly report feeling depressed. Therapy is supported as an effective means of treating mental anxiety and depression, and lessening their severity. But therapy is expensive and not always covered by insurance. It is well known that exercise provides physiological and psychological benefits to those suffering from mental health disorders. However, prescribing and monitoring exercise can be challenging, if not impossible, for mental health practitioners, and individuals often are unsure how to begin an exercise program on their own. Studies that have investigated the impact on exercise on mental health have delivered exercise using a traditional clinical trial exercise structure, where exercise is completed by the client\u002Fpatient under the supervision of a professional. This structure, while beneficial, does not always transfer well to real-world settings. Working one-on-one with an exercise professional poses financial and scheduling barriers for most. Few, if any, studies have used group exercise and group therapy to address mental health concerns. This study aims to combine cardiovascular exercise with group therapy to investigate the impact of cardiovascular fitness on mental health outcomes among Rural dwelling adults living with generalized anxiety and\u002For depressive disorders.",[28,304],"Depressive and Anxiety Disorders",[306,307,308,309,310],"cardiovascular fitness","mental health","anxiety","depression","group exercise","2026-04-14",{"date":313,"type":42},"2026-04-21",{"date":106,"type":22},{"date":316,"type":22},"2026-12-31",{"name":318,"class":49},"Emporia State University",{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":23,"phases":328,"briefSummary":329,"conditions":330,"keywords":332,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":50},"100588169","transdiagnostic-metacognitive-therapy-compared-to-disorder-specific-cognitive-behavioral-therapy-for-anxiety-disorders-100588169","NCT06937892","Transdiagnostic Metacognitive Therapy Compared to Disorder-Specific Cognitive-Behavioral Therapy for Anxiety Disorders","Transdiagnostic Metacognitive Therapy Compared to Disorder-Specific Cognitive-Behavioral Therapy for Anxiety Disorders: A Randomized Controlled Superiority Trial","Inclusion Criteria:\n\n* 18 years of age or older\n* A principal (most interfering and\u002For severe) diagnosis of GAD, SAD or PTSD\n* If on pharmacological treatment, no change in dose during the last six weeks\n* Ability to read and speak Swedish\n\nExclusion Criteria:\n\n* A current diagnosis of psychotic disorder, bipolar disorder, neurocognitive disorder, or moderate to severe substance use disorder\n* Acute risk of suicide\n* Simultaneous psychological treatment",{"count":327,"type":22},86,[25],"Background\n\nAnxiety disorders are the most prevalent psychiatric disorders around the world.\n\nEffective treatment consists of pharmacotherapy or psychological treatment based on cognitive-behavioral therapy (CBT) and these treatment options are recommended in clinical guidelines, with CBT as the first-line treatment for anxiety disorders. However, only 50% of patients with anxiety disorders achieve remission status following CBT and 20% of patients drop out of CBT.\n\nMetacognitive therapy (MCT) represents an alternative treatment approach to CBT. The theoretical model of MCT emphasizes the role of dysfunctional metacognitions (rather than cognitions, as in CBT), particularly negative metacognitions, in the development and maintenance of anxiety disorders and other psychiatric disorders. Metacognitions refer to cognitions about cognition, for example, a belief such as \"When I start worrying, I cannot stop\". Several meta-analyses indicate that MCT may be superior to CBT for various psychiatric disorders. However, more studies with larger samples are required to draw firm conclusions about the effectiveness of MCT.\n\nAn alternative approach to disorder-specific treatment is transdiagnostic treatment; that is, the application of a single, generic protocol for several disorders. There are advantages of transdiagnostic treatments in comparison to disorder-specific treatments in terms of therapist learnability (i.e., easier to learn one protocol than several) and dissemination into routine care. Despite the MCT model being described as applicable to a range of psychiatric disorders and MCT as a potentially transdiagnostic approach, at present there is only one sufficiently large study that compared transdiagnostic MCT (tMCT) to disorder-specific CBT.\n\nPurpose and aims\n\nThe purpose of the present project is to investigate the effectiveness of tMCT compared to disorder-specific CBT in patients with anxiety disorders in psychiatric care and evaluate the cost-effectiveness. Aim 1 is to compare the short- and long-term effects of tMCT and CBT, from pre- to post-assessment and from post-assessment to 6- and 12-month follow-up assessments. Aim 2 is to examine possible mediators of change (metacognitions and cognitions). Aim 3 is to compare the cost-effectiveness of tMCT to CBT.\n\nDesign and setting\n\nThe project has a prospective, pragmatic, two-arm parallel-group randomized controlled superiority trial design and is conducted in psychiatric services in Stockholm, Sweden. Treatment is conducted in an individual format and face-to-face.\n\nRandomization and blinding\n\nEach participant is stratified individually on principal diagnosis prior to randomization and then randomly allocated with a 1:1 ratio to tMCT or CBT. A list of random numbers is generated for each diagnosis for each psychiatric unit by an individual independent of the project. Researchers, therapists, participants, and independent assessors are blinded to the allocation sequence. Assessors are also blinded to treatment condition at post-treatment assessment. Researchers are blinded to treatment allocation in the analysis phase at all assessment points.\n\nTherapist training and supervision\n\nTherapists are licensed psychologists or psychotherapists with prior training in CBT and employed in psychiatric services in Stockholm, Sweden. Only therapists who can show competence in MCT and CBT, respectively, are allowed to treat participants in the project.\n\nProcedure\n\nPatients are consecutively assessed for eligibility by project therapists. As part of routine clinical care, patients are assessed for principal and comorbid diagnoses. Patients meeting criteria for GAD, SAD, or PTSD are assessed whether they meet other inclusion but not exclusion criteria for participation in the project. Patients provide written informed consent to therapists. At pre-treatment, participants complete outcome measures. Participants are then randomly assigned to tMCT or CBT. Following the last session, and at 6-month and 12-month follow-up assessments, participants complete the same measures as at pre-treatment. In addition, at post-treatment principal and comorbid diagnoses are assessed by independent assessors.\n\nData analysis\n\nMultilevel modeling is used to estimate between-group effects on outcome measures from pre- to post-assessment (following treatment completion; primary endpoint), and from post-assessment to 6- and 12-month follow-up assessments. To be comparable across diagnoses, scores on the primary outcome of disorder-specific measures are standardized by calculating z-scores. Missing data are estimated using maximum likelihood estimation. Data from all randomized participants are used in the multilevel models, following the principle of intention-to-treat.\n\nA detailed study protocol has been submitted for publication.",[28,331,192],"Social Anxiety Disorder (SAD)",[333,334,335,336],"Metacognitive therapy","Cognitive-behavioral therapy","Transdiagnostic treatment","Anxiety disorders","2026-03-23",{"date":339,"type":42},"2026-03-27",{"date":341,"type":42},"2025-08-27",{"date":343,"type":22},"2028-12",{"name":345,"class":49},"Karolinska Institutet",{"id":347,"slug":348,"hasResults":11,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":11,"sex":17,"minAge":353,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":189,"phases":4,"briefSummary":356,"conditions":357,"keywords":378,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":50},"100577917","lhc-cidi-5-in-hong-kong-100577917","NCT06804525","LHC-CIDI-5 in Hong Kong","Use of Life History Calendars to Enhance Measurement of Lifetime Experience With Mental Disorders in Hong Kong.","Inclusion Criteria:\n\n* All household members aged 25 years old and over are randomly sampled from the Census and Statistics Department List of Quarters\n* Live in the address sampled from the Census and Statistics Department List of Quarters\n* Reside in Hong Kong for at least six months in the past year\n* Able to read and communicate in Chinese or English\n* Without linguistic or cognitive difficulties\n\nExclusion Criteria:\n\n* Domestic workers","25 Years",{"count":355,"type":22},2500,"The World Health Organization Composite International Diagnostic Interview-5th (CIDI-5) is a standardized diagnostic tool used to assess the prevalence of mental and substance use disorders over varying time frames (30 days, 12 months, and lifetime) based on the diagnostic criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) and International Classification of Diseases 10th edition (ICD-10). However, retrospective measurements like the CIDI-5 are susceptible to recall bias, especially for the lifetime experience, which can hinder the reporting accuracy with mental disorders.\n\nTo mitigate this issue, the life history calendar (LHC) was introduced as an aid to assist respondents in recalling the timing of life events, enhancing the ability of the CIDI-5 to measure the lifetime prevalence of mental disorders. The LHC is a grid structure with columns representing time units and rows representing life domains under study.\n\nIn a study conducted in Nepal, combining the CIDI-5 with the LHC resulted in a significant increase in the detection of mental disorders compared to using the CIDI-5 alone. This approach did not lead to an increase in false positives after clinical validation.\n\nThis experiment aims to adapt a Hong Kong version of the LHC based on the Nepalese model and evaluate the effectiveness of the LHC-assisted CIDI-5 (LHC-CIDI-5) compared to the CIDI-5 alone in assessing mental disorders.",[358,171,359,360,361,362,363,364,365,366,367,368,369,28,370,371,372,373,192,374,375,376,377],"Major Depressive Episode (MDE)","Persistent Depressive Disorder (PDD)","Suicidal Ideation","Suicidal Plan","Suicidal Attempt","Suicidal Gesture","Nonsuicidal Self-Injury","Manic Episode","Hypomanic","Bipolar I Disorder","Bipolar Sub Disorder","Bipolar II Disorder","Intermittent Explosive Disorder (IED)","Panic Attack","Panic Disorder","Obsessive-Compulsive Disorder (OCD)","PCL-SC PTSD","PCL-5 PTSD","Alcohol Use Disorder (AUD)","Substance Use Disorder (SUD)",[379,194,380,381,195,196],"Life History Calendar","Recall bias","Retrospective reporting","2026-03-09",{"date":384,"type":42},"2026-03-10",{"date":386,"type":42},"2025-01-18",{"date":388,"type":22},"2027-04",{"name":206,"class":49},{"id":391,"slug":392,"hasResults":11,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":398,"enrollmentInfo":399,"targetDuration":4,"studyType":23,"phases":401,"briefSummary":403,"conditions":404,"keywords":406,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":50},"100602435","phase-3-cannabidiol-assisted-learning-for-managing-generalized-anxiety-disorder-100602435","NCT07123467","Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder","Cannabidiol-Enhanced Cognitive Behavioral Therapy for Generalized Anxiety Disorder","CALM","Inclusion Criteria:\n\n* Right-handed\n* Age 18-45 years at enrollment\n* Able to consent to the study\n* Agree to adhere to lifestyle considerations throughout study duration\n* Generally medically and neurologically healthy, including no evidence of intellectual disability or serious cognitive impairment\n* Have a current generalized anxiety disorder (GAD) diagnosis according to the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria and\u002For total scores ≥ 8 on the 7-Item Generalized Anxiety Disorders Scale (GAD-7)\n\nExclusion Criteria:\n\n* Clinically significant medical or neurologic condition or neurocognitive dysfunction that would affect function and\u002For task performance and\u002For interfere with the study protocol\n* Any current (or within past 2 months) medical condition requiring medication that would interact with cannabidiol or interfere with the study protocol\n* Risk of harm to self or others that requires immediate intervention\n* Presence of contraindications, current or past allergic or adverse reaction, or known sensitivity to cannabinoid-like substances or components of EPIDIOLEX®\n* Positive drug screen or alcohol breathalyzer\n* Unwilling\u002Funable to sign informed consent document\n* Currently pregnant (positive pregnancy test), planning pregnancy, or lactating (women),\n* Under 18 or over 45 years of age\n* Traumatic brain injury, as defined by The American Congress of Rehabilitation as a person who has had a traumatically induced physiological disruption of brain function (i.e., the head being struck, the head striking an object, and\u002For the brain undergoing an acceleration\u002Fdeceleration movement \\[i.e., whiplash\\] without direct external trauma to the head), as manifested by at least one of the following: any loss of consciousness; any loss of memory for events immediately before or after the injury; any alteration in mental status at the time of the incident; or focal neurological deficits that may or may not be transient)\n* Inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia), as determined by self-report and\u002For a preliminary session in a mock scanner\n* Presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel\u002Fretained particles)\n* Receiving concurrent psychotherapy or have received psychotherapy, including for research purposes, within the past year\n* Current moderate or severe alcohol\u002Fdrug use disorder or in the past 8 weeks\n* Current or past diagnosis of bipolar and other related disorders, schizophrenia spectrum, or other psychotic disorders;\n* GAD-7 score \\\u003C 8\n* Use of medications known to have severe drug interactions with cannabidiol or that are strong inducers of cytochrome P450 3A4 (CYP3A4) or cytochrome P450 2C19 (CYP2C19)\n* Visual impairment\n* Baseline labs 3 times outside of normal range\n* Use of as needed anti-anxiety medications (e.g., benzodiazepines), unstable dose of other psychoactive drug (i.e., \\\u003C 4 weeks), or intention to start new treatment during this trial\n* Current or past-month use of cannabis, or a tetrahydrocannabinol (THC) or cannabidiol-containing product (self-report and urine drug screen)\n* Current or past-month coronavirus disease 2019 (COVID-19) diagnosis or febrile illness\n* Treatment with another investigational drug or intervention within the past month\n* Difficulty with or inability to comply with the complete clinical trial.","45 Years",{"count":400,"type":22},90,[402],"PHASE3","This randomized, double-blind, placebo-controlled clinical trial investigates the use of Food and Drug Administration (FDA)-approved cannabidiol (EPIDIOLEX®) as an adjunct to cognitive behavioral therapy (CBT) in adults with generalized anxiety disorder (GAD). The study aims to evaluate whether cannabidiol-assisted CBT enhances emotion regulation via dorsomedial prefrontal cortex (dmPFC) activation and improves anxiety symptom outcomes compared to CBT with placebo.",[28,405],"Anxiety Disorders",[407,408,409,37,410],"Cannabidiol","EPIDIOLEX","Cognitive Behavioral Therapy","functional magnetic resonance imaging","2026-03-06",{"date":382,"type":42},{"date":414,"type":42},"2025-11-03",{"date":416,"type":22},"2027-08-31",{"name":418,"class":49},"Wayne State University",{"id":420,"slug":421,"hasResults":11,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":425,"eligibilityCriteria":426,"healthyVolunteers":11,"sex":17,"minAge":427,"maxAge":428,"enrollmentInfo":429,"targetDuration":4,"studyType":23,"phases":431,"briefSummary":432,"conditions":433,"keywords":437,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":50},"100610481","stepped-care-treatment-for-anxiety-resilience-100610481","NCT07228143","Stepped Care Treatment for Anxiety Resilience","Stepped Care Cognitive Behavioral Therapy for Children and Adolescents With Anxiety","STAR","Inclusion Criteria:\n\n* A primary diagnosis of OCD or an anxiety disorder including separation anxiety disorder, social phobia, generalized anxiety disorder, specific phobia, agoraphobia, panic disorder, as determine by an IE using the DIAMOND-KID diagnostic interview.\n* Score of ≥ 14 on the PARS (items 2-7) which corresponds to clinically significant anxiety.\n* The child is 7-17 years old.\n* Residence in Texas and located in the state of Texas during treatment sessions.\n\nExclusion Criteria:\n\n* -Psychosis, cognitive disability, any condition that would limit the caregiver's ability to follow instructions.\n* Parent substance use disorder within the past 3 months, which could impact their ability to implement step 1\n* Child or parent is suicidal. A delayed entry once the parent or child is stabilized (\\>6 months post suicidality) and no longer has suicidal ideation will be allowed if appropriate.\n* New pharmacological interventions or treatment changes: Initiation of an antidepressant within 12 weeks before study enrollment or 6 weeks for an antipsychotic, benzodiazepine, or attention deficit hyperactivity disorder (ADHD) medication before enrollment, or any change in established psychotropic medication (e.g., antidepressants, anxiolytics) within 6 weeks before study enrollment (4 weeks for antipsychotic, anti-anxiety, benzodiazepine, or ADHD medication changes). Medications will remain stable during treatment.","7 Years","17 Years",{"count":430,"type":22},106,[25],"Childhood anxiety disorders (CAD) are common and impairing. Family based cognitive behavioral therapy (CBT) is efficacious in treating CAD. Yet, many children do not receive care due to barriers such as limited provider availably, high treatment costs, and constrained family resources (e.g., time). To combat these barriers, other treatment methods have been developed.\n\nThe stepped care treatment models maximize resources by providing low-intensity, low-cost interventions as a first time treatment, while stepping up care for those needing more intensive treatment. Specifically, a stepped care model for CAD that begins with a parent-focus intervention has great promise to deliver efficacious and cost-effective treatment without having to engage the child.\n\nWhile stepped care approaches show promise in treating CAD with comparable efficacy to standard CBT, there remains a large research-to-practice gap. The stepped care model for CAD that begins with a parent-focused intervention has yet been explored, and very little is known about intervention mediators that explain mechanisms of change.\n\nThis research is being done to improve the reach and quality of services using a stepped care model, offering an affordable and practical solution to the widespread gap in youth mental health care.",[28,331,221,434,435,436],"Specific Phobia","Obsessive Compulsive Disorder (OCD)","Panic Disorder (With or Without Agoraphobia)",[243,438,439,440,441,442],"Child","Adolescents","Obsessive compulsive disorder","stepped care","psychotherapy","2026-02-27",{"date":445,"type":42},"2026-03-02",{"date":447,"type":42},"2026-01-05",{"date":449,"type":22},"2028-04-30",{"name":451,"class":49},"Andrew Wiese",{"id":453,"slug":454,"hasResults":11,"nctId":455,"briefTitle":456,"officialTitle":456,"acronym":4,"eligibilityCriteria":457,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":23,"phases":460,"briefSummary":461,"conditions":462,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":4},"100610254","therapy-and-tech-study-100610254","NCT07225192","Therapy and Tech Study","Inclusion Criteria:\n\n* 18+\n* US Resident\n* English-speaking\n* Self-report having been treated for or diagnosed with generalized anxiety disorder or major depressive disorder by a licensed provider (e.g., MD, DO, LPCC, LCSW, LMFT) in the past 12 months\n* Self-report currently being in individual therapy\n\nExclusion Criteria:\n\n* Ever diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or hospitalized for suicidality",{"count":459,"type":22},204,[25],"The investigators want to test if gen AI can support therapy by recruiting patients already in therapy.",[28,463],"Major Depressive Disorder","2025-11-17",{"date":466,"type":42},"2025-11-21",{"date":468,"type":22},"2025-11",{"date":470,"type":22},"2026-01",{"name":472,"class":49},"University of California, Irvine",{"id":474,"slug":475,"hasResults":11,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":479,"eligibilityCriteria":480,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":23,"phases":483,"briefSummary":484,"conditions":485,"keywords":486,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":50},"100608460","the-effect-of-patient-preference-for-treatment-model-in-internet-delivered-cognitive-behavior-therapy-for-generalized-anxiety-disorder-100608460","NCT07201844","The Effect of Patient Preference for Treatment Model in Internet Delivered Cognitive Behavior Therapy for Generalized Anxiety Disorder","ORIGAMI: Internetbaserad Behandling för GAD. Effekten av Att få välja Behandling själv Samtbehandlarens förmåga Att Matcha Patienter Till rätt Behandling. En Randomiserad kontrolleradprövning.","ORIGAMI","Inclusion Criteria:\n\n* 18 years or older.\n* Meet diagnostic criteria for GAD according to DSM-5, as assessed by a psychologist on a video-call.\n* Self-rated score ≥ 7 on GAD-7.\n* Can read and speak Swedish fluently.\n* Have access to a smartphone, tablet, or computer and a Swedish BankID which allows access to the video-calls and treatment platform.\n* Have the time and possibility to participate in the 10 week treatment.\n* Consents to participate.\n\nExclusion Criteria:\n\n* Patients that are judged to be in greater need of another psychiatric treatment for another psychiatric diagnosis (for example severe depression) and\u002For is judged to have a high risk of suicide.\n* Current drug or alcohol abuse.\n* Current severe somatic health concern or social vulnerability if this is judged to be too great an obstacle for the patient to carry out the treatment.",{"count":482,"type":22},440,[25],"The goal of this clinical trial is to investigate the effect of allowing patients to choose between two internet-based cognitive behavioral treatments (ICBT) for generalized anxiety disorder (GAD). The goal is also to examine psychologists' ability to predict which of the two treatments the patient will benefit most from.\n\nThe main questions it aims to answer are:\n\n* Do patients who are randomized to choose their treatment improve more in their GAD symptoms compared to patients who are randomly assigned to a treatment?\n* Does allowing patients to choose their treatment increase treatment adherence, compared to being randomly assigned to a treatment?\n* Does allowing patients to choose their treatment increase treatment satisfaction and credibility, compared to being randomly assigned to a treatment?\n* Does allowing patients to choose their treatment increase patients' sense of agency related to the treatment process, compared to being randomly assigned to a treatment?\n* Do patients who receive a treatment that matches the psychologist's prediction of which treatment would fit the patient best show better treatment outcomes (primarily reduction in GAD symptoms over time, but also secondary outcomes such as satisfaction), compared to patients who receive a treatment that does not match the psychologist's prediction?\n\nParticipants included in the trial will be randomized to one of two conditions: 1) read short descriptions of the two treatment programs and based on that choose the preferred treatment, 2) randomly being allocated to one of the two treatments. The two internet-based treatment programs which the patients can choose between or be randomly allocated to are: 1) Intolerance of uncertainty-based ICBT and 2) Metacognition-based ICBT. Both programs consist of 8 treatment modules and run for 10 weeks. Patients in both conditions receive continuous support by a psychologist through a built-in message function on the treatment platform. The patient will receive feedback from the psychologist on their assignments and exercises and the psychologist will respond to the participants' messages.",[28],[487,488,489,490,491],"Internet interventions","Digital mental health services","cognitive behaviour therapy","patient preferences","psychiatry","2025-09-23",{"date":494,"type":42},"2025-10-01",{"date":496,"type":42},"2025-08-26",{"date":498,"type":22},"2028-08-31",{"name":345,"class":49},{"id":501,"slug":502,"hasResults":11,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":11,"sex":17,"minAge":508,"maxAge":19,"enrollmentInfo":509,"targetDuration":4,"studyType":23,"phases":511,"briefSummary":512,"conditions":513,"keywords":514,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":4},"100606577","internet-based-cognitive-behavioral-therapy-with-treatment-as-usual-for-generalized-anxiety-disorder-and-major-depressive-disorder-in-taiwan-icbt-tw-100606577","NCT07177365","Internet-Based Cognitive Behavioral Therapy With Treatment as Usual for Generalized Anxiety Disorder and Major Depressive Disorder in Taiwan (ICBT-TW)","ICBT Clinical Validation - A Clinical Study on Internet-based Cognitive Behavioral Intervention for Generalized Anxiety Disorder and Major Depressive Disorder","ICBT-TW","Inclusion Criteria:\n\n* Age between 20 and 65 years.\n* Diagnosis of Generalized Anxiety Disorder (GAD) confirmed by a psychiatrist.\n* Diagnosis of Major Depressive Disorder (MDD) confirmed by a psychiatrist, without acute suicidal risk (screened by PHQ-9 Item 9; score of 3 requires further clinical assessment to exclude active suicidal plan or recent self-harm).\n\nExclusion Criteria:\n\n* For GAD ICBT participants\n\n  * Current or past history of obsessive-compulsive disorder, panic disorder, bipolar disorder, eating disorder, schizophrenia, or substance abuse.\n  * Severe depressive symptoms impairing daily functioning.\n  * Current suicidal ideation.\n  * Experiencing acute life stressors (e.g., domestic violence, ongoing treatment for serious physical illness).\n  * Currently receiving psychological counseling or psychotherapy.\n  * Other serious factors limiting participation (e.g., intellectual disability, significant cognitive impairment, severe vision or hearing impairment).\n* For MDD ICBT participants\n\n  * Diagnosis of bipolar disorder, eating disorder, schizophrenia, psychotic symptoms, or substance abuse.\n  * Current suicidal ideation or recent self-harm (PHQ-9 Item 9 score of 3 triggers further assessment; exclusion if active suicidal plan or recent self-harm present).\n  * Experiencing acute life stressors (e.g., domestic violence, ongoing treatment for serious physical illness).\n  * Currently receiving psychological counseling or psychotherapy.\n  * Other serious factors limiting participation (e.g., intellectual disability, significant cognitive impairment, severe vision or hearing impairment).","20 Years",{"count":510,"type":22},120,[25],"This study aims to evaluate the effectiveness of internet-based cognitive behavioral therapy (ICBT) combined with treatment as usual (TAU) for adults diagnosed with generalized anxiety disorder (GAD) or major depressive disorder (MDD) in Taiwan.\n\nCBT is a proven treatment for anxiety and depression, but traditional face-to-face sessions require frequent clinic visits, which may be costly and time-consuming. ICBT delivers similar therapy content online, allowing participants to complete sessions at their own pace, reducing barriers such as travel and scheduling.\n\nA total of 160 participants will be randomly assigned to receive either TAU alone or TAU plus an 8-week ICBT program delivered via a secure national research platform. The program includes 12 online modules covering cognitive restructuring, emotion regulation, and behavioral activation techniques. Participants will complete assessments before, during, and after the program, with follow-up at 3 months.\n\nThe results will help determine whether ICBT can improve symptoms, enhance treatment accessibility, and support the integration of digital mental health interventions into clinical practice in Taiwan.",[28,171],[515,516,517,518,126,519,520,521,522,523],"Internet-Based Cognitive Behavioral Therapy","ICBT","Digital Mental Health","Online Therapy","Cognitive Restructuring","Mindfulness","Self-Compassion","Taiwan","Treatment as Usual (TAU)","2025-09-17",{"date":526,"type":42},"2025-09-22",{"date":528,"type":22},"2025-09-20",{"date":530,"type":22},"2026-06-30",{"name":532,"class":49},"National Health Research Institutes, Taiwan",{"id":534,"slug":535,"hasResults":11,"nctId":536,"briefTitle":537,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":11,"sex":17,"minAge":427,"maxAge":428,"enrollmentInfo":540,"targetDuration":4,"studyType":23,"phases":542,"briefSummary":543,"conditions":544,"keywords":549,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":50},"100594846","comparative-effectiveness-of-internet-based-versus-parent-coached-cognitive-behavioral-therapy-for-children-and-adolescents-with-anxiety-and-ocd-100594846","NCT07024758","Comparative Effectiveness of Internet-based Versus Parent-Coached Cognitive-Behavioral Therapy For Children and Adolescents With Anxiety and OCD","ASTRO","Inclusion Criteria:\n\n* The child is between the ages of 7 to 17 years inclusive at enrollment.\n* The child has clinically significant symptoms of anxiety and\u002For OCD, as indicated by a score of 12 or higher on the Pediatric Anxiety Rating Scale (PARS).\n* The child is appropriate for anxiety-focused treatment (e.g., anxiety or OCD is the primary or co-primary problem as diagnosed using the DIAMOND-KID).\n* One parent\u002Fguardian is able and willing to participate in assessment and treatment (e.g., has sufficient English fluency, the decisional capacity to participate, and can commit to treatment duration).\n* The participating parent\u002Fguardian lives with their child at least 50% of the time per self-report.\n* Both parent and child can read and understand English.\n* The participant has an IQ above 69, based on the KBIT-2, another valid test or clinician judgement (e.g., a previous assessment conducted, and report shared with study team).\n* Participants must be in the state of Texas for treatment sessions\u002Fassessments.\n\nExclusion Criteria:\n\n* The child has a diagnosis of a lifetime psychotic disorder and\u002For conduct disorder.\n* The child has significant, current and active suicidality\u002Fhomicidality and\u002For self-injury requiring medical intervention.\n* The child has limited verbal communication abilities (e.g., no independent verbal communication).\n* The child is receiving concurrent psychotherapy with anxiety and\u002For OCD as the primary focus. They can pause ongoing therapy to enroll.\n* The child has initiated new antidepressant medication within 12-weeks of assessment (4-weeks for stimulants\u002Fbenzodiazepines\u002Fantipsychotics) or during therapy.\n* The child has changed psychotropic medication dosage within 4-weeks of assessment (2-weeks for stimulants\u002Fbenzodiazepines\u002Fantipsychotics) or during therapy.\n* The child requires a higher level of care than can be provided through the study (e.g., significant, current suicidal ideation).",{"count":541,"type":22},174,[25],"Anxiety disorders in children and adolescents are common and confer significant disability. Cognitive behavioral therapy (CBT) is the recommended treatment for youth with anxiety, yet many families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. To combat these barriers, other treatment methods have been developed.\n\nPrevious research has shown that family-based, internet-delivered CBT (iCBT) for anxiety and OCD in youth has shown a significant reduction in anxiety symptoms. Parent-coached exposure therapy (PCET) focuses entirely on teaching parents and youth together how to address anxiety through the completion of in-session parent-coached exposures and assigning parent-coached exposure as homework in between sessions.\n\nAlthough both iCBT and PCET show positive results in treating pediatric anxiety in comparison to standard-care CBT, little is known about the comparative efficacy of iCBT and PCET.\n\nThis research is being done to understand the comparative effectiveness of two different types of cognitive-behavioral therapy (CBT) for treating anxiety or OCD in youth.",[435,545,546,28,221,372,547,436,548],"Anxiety Disorder of Childhood or Adolescence","Social Anxiety Disorder of Childhood","Panic Attacks","Phobia, Specific",[550,308,551,552,553],"Obsessive-compulsive disorder","cognitive-behavioral therapy","children","adolescents","2025-07-18",{"date":556,"type":42},"2025-07-20",{"date":558,"type":42},"2025-07-01",{"date":560,"type":22},"2028-06-30",{"name":562,"class":49},"Baylor College of Medicine",{"id":564,"slug":565,"hasResults":11,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":4,"eligibilityCriteria":569,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":85,"enrollmentInfo":570,"targetDuration":4,"studyType":23,"phases":572,"briefSummary":573,"conditions":574,"keywords":575,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":580,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":50},"100590573","phase-2-safety-tolerability-and-preliminary-efficacy-of-psilocybin-oral-solution-in-adults-with-generalized-anxiety-disorder-100590573","NCT06969170","Safety, Tolerability, and Preliminary Efficacy of Psilocybin Oral Solution in Adults With Generalized Anxiety Disorder","A Phase 2a, Placebo-Controlled Randomized, Double-Blind Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Psilocybin Oral Solution in Adults With Generalized Anxiety Disorder","Inclusion Criteria:\n\n1. Must provide written informed consent prior to the initiation of any protocol-specific procedures.\n2. Male and female adults, between 18 and 60 years of age, inclusive.\n3. Meets DSM-V criteria for a primary diagnosis of GAD at Screening (duration of diagnosis ≥1 year, based on self-report), confirmed using the MINI.\n4. Clinician-rated GAD-7 score ≥14 at Screening (Visit 1).\n5. Clinician-rated HAM-A score ≥14 at Screening (Visit1).\n6. Females must be non-pregnant and non-lactating and must fulfil at least one of the following:\n\n   * Be surgically sterile for a minimum of 6 months (achieved through hysterectomy, oophorectomy, or bilateral salpingectomy; note that tubal ligation is not considered a method of permanent sterilization).\n   * Post-menopausal for a minimum of 1 year (confirmed by follicle-stimulating hormone test).\n   * Agree to avoid pregnancy and use a medically acceptable method of contraception with male sexual partners from at least 30 days prior to the study until 30 days after the study has ended (last study procedure).\n   * Medically acceptable methods of contraception include any of the following:\n   * Double-barrier methods (e.g., male condom, spermicide with diaphragm or spermicide with cervical cap)\n   * Oral contraceptives; hormonal patch, implant or injection; or hormonal or non-hormonal intrauterine device. The male partner should use, at all times, a male condom with spermicide, should the female Patient choose to use any of these methods\n   * Complete abstinence, should it be in line with the Patient's preferred and usual lifestyle.\n7. Males who are able to father children must agree to use medically acceptable methods of contraception during the study and for 30 days after the last study drug administration. If a patient's partner should become pregnant during his participation in the study and for 30 days after he has completed his last study drug administration, the patient must inform study staff immediately. Medically acceptable methods of contraception include:\n\n   * Using a condom with a female partner of child-bearing potential who is using oral contraceptives; hormonal patch, implant or injection; hormonal or non-hormonal intrauterine device; or diaphragm or cervical cap with spermicide\n   * Complete abstinence, should it be in line with the patient's preferred and usual lifestyle.\n8. Males must refrain from sperm donation from clinic admission to at least 30 days after the last dose of study drug.\n9. Must be able to speak, read, and understand English sufficiently to allow completion of all study assessments.\n10. Must be willing to comply with the requirements and restrictions of the study.\n\nExclusion Criteria:\n\n1. Personal history of schizophrenia, bipolar affective disorder, delusional disorder, paranoid disorder, moderate or severe panic disorder, moderate or severe social anxiety disorder, schizoaffective disorder, moderate or severe obsessive-compulsive disorder, anorexia nervosa, bulimia nervosa, moderate or severe post-traumatic stress disorder (as assessed by the IES-R), moderate or severe personality disorder (Cluster B and Cluster C only), moderate or severe MDD (as assessed by the MINI and total scores on the MADRS \\> 19).\n2. History or presence of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other disease at Screening, which, in the opinion of the investigator, would jeopardize the safety of the patient or the validity of the study results.\n3. Recently initiated non-pharmacological treatment (e.g., Cognitive Behavioral Therapy, psychotherapy) with a psychologist or health care professional (i.e., \\\u003C4 weeks prior to Screening). Patients who began a stable non-pharmacological treatment regimen \\>4 weeks prior to Screening will be permitted. Patients currently stable on treatment will not be permitted to modify or introduce new elements to their existing treatment regimen while enrolled in the study.\n4. Currently taking pharmacological treatment for GAD or depressive symptoms on a daily basis as outlined in Table 2. Patients who discontinue pharmacological treatment within a minimum of 4 weeks or more of baseline will be permitted to enroll in the study. Sporadic, prn use of anxiolytics will be permitted; however, patients will be required to document all medication use prior to study enrollment (See Section 9.7).\n5. Clinically significant abnormality on ECG, including a QT interval corrected for heart rate (Bazett; QTcB interval) of \\>440 milliseconds in males and \\>460 milliseconds in females.\n6. History of allergies to the investigational product or excipients.\n7. History of seizures, family history of seizures, history of head trauma, history of neurosurgery, or close family history of idiopathic generalized epilepsy or other congenital epilepsies.\n8. Positive for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody.\n9. Positive urine drug screen at Screening , inclusive of cannabis use at a rate above 0.5g\u002Fday or 3g\u002Fweek;\n\n   \\- Abstinence commitment clause: Patients who use cannabis at below or up to the frequency\u002Famount listed above may be allowed to participate if they are willing and able to discontinue use for the duration of the study period without experiencing withdrawal symptoms.\n10. Current or history of moderate or severe drug or alcohol use disorder (excluding caffeine and nicotine) within the past 2 years, or lifetime history of participation in a drug rehabilitation program (other than treatment for smoking cessation).\n11. Has used CNS drugs with perception-altering properties (e.g., ketamine, lysergic acid diethylamide \\[LSD\\], phencyclidine \\[PCP\\], 3,4 methylenedioxymethamphetamine \\[MDMA\\], mescaline, psilocybin, tryptamine derivatives, or ring-substituted amphetamines with perception-altering effects) on more than 1 occasion for therapeutic or non-therapeutic purposes (i.e., for psychoactive effects) within the past 6 months. History of single or episodic use will not be considered exclusionary.\n12. History of suicidal ideation in the past 12 months or active\u002Fcurrent suicidality, based on C-SSRS results.\n13. Is currently using an investigational drug or device or has used such in the 30 days prior to receiving study drug.\n14. Female patient is pregnant or breastfeeding.\n15. Patient, in the investigator's opinion, is unsuitable for clinical study participation.\n\nCriteria for Randomization into the Double-Blind Treatment Phase\n\n1\\. Minimum 50% reduction in GAD-7 score from Open-Label Baseline Visit (Visit 1) to Double-Blind Baseline Visit",{"count":571,"type":22},50,[61],"This Phase 2a clinical trial is designed to evaluate the safety, tolerability, and preliminary efficacy of a 3 mg dose of psilocybin oral solution for the treatment of Generalized Anxiety Disorder (GAD).\n\nThe study consists of three sequential phases: Screening Phase (up to 4 weeks), Open-label Run-in Phase (4 weeks), Double-blind Treatment Phase (4 weeks)\n\nScreening Phase During the Screening Visit, participants will provide informed consent and undergo a comprehensive medical evaluation, including an abbreviated psychiatric assessment, to determine eligibility. To qualify, patients must have a clinician-rated Hamilton Anxiety Rating Scale (HAM-A) score ≥14. Additionally, participants must not be on regular anxiolytic treatment or must have discontinued such treatment at least 4 weeks prior to the start of the Open-label Run-in Phase.\n\nOpen-label Run-in Phase Eligible patients will proceed to the 4-week Open-label Run-in Phase. During this phase, patients will attend four weekly clinic visits, supplemented by weekly remote contacts (via phone or email).\n\nAt different timepoints during the OL Run-in Phase, participants will complete safety assessments, undergo cognitive testing and EEG and other patient reported outcomes (PROs).\n\nDouble-blind Treatment Phase Participants who demonstrate a treatment response during the Open-label Phase-defined as a ≥50% reduction in GAD-7 score from baseline-will be randomized 1:1 to receive either psilocybin oral solution or placebo at the Double-blind Baseline Visit. Patients not meeting the response criteria will undergo End-of-Treatment (ET) procedures at this visit.\n\nAt different timepoints during the DB Treatment Phase, participants will complete safety assessments, undergo cognitive testing and EEG and other patient reported outcomes (PROs).\n\nCompletion of the End of Treatment (ET) phase will be 2 weeks to further assess safety and PROs.",[28],[576,577,578,37],"Psilocybin","Double-Blind","Psychedelic","2025-05-08",{"date":581,"type":42},"2025-05-13",{"date":583,"type":22},"2025-05-06",{"date":585,"type":22},"2026-08-30",{"name":587,"class":49},"Queen's University",{"id":589,"slug":590,"hasResults":11,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":4,"eligibilityCriteria":594,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":595,"targetDuration":4,"studyType":23,"phases":597,"briefSummary":598,"conditions":599,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":600,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":604,"locationsCount":50},"100590766","metacognitive-therapy-vs-unified-protocol-for-patients-with-comorbid-anxiety-disorders-100590766","NCT06971692","Metacognitive Therapy vs Unified Protocol for Patients With Comorbid Anxiety Disorders","Transdiagnostic Therapy With Metacognitive Therapy Versus Unified Protocol for Patients With Comorbid Anxiety Disorders: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18 years or above\n* Ability to read and speak Swedish\n* A principal diagnosis of post-traumatic stress disorder, generalized anxiety disorder, social anxiety disorder, or panic disorder\n* At least one additional comorbid diagnosis (one of the above diagnoses, or obsessive-compulsive disorder, or major depressive disorder)\n* Patients on psychotropic medication must have been on a stable dose (excluding as-needed medication) for at least six weeks prior to treatment initiation\n\nExclusion Criteria:\n\n* Current diagnosis of psychosis, bipolar disorder or moderate to severe substance use disorder\n* Medium to high suicide risk\n* Psychiatric, somatic or social problems that require primary intervention other than the treatments offered in the study\n* Concurrent psychological treatment",{"count":596,"type":22},114,[25],"The primary goal of this randomized controlled trial is to compare the effectiveness of two transdiagnostic psychological treatments, Metacognitive Therapy (MCT) and the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), for patients with complex anxiety.",[192,28,331,436],{"date":202,"type":42},{"date":602,"type":22},"2025-08",{"date":343,"type":22},{"name":345,"class":49},{"id":606,"slug":607,"hasResults":11,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":611,"eligibilityCriteria":612,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":613,"targetDuration":4,"studyType":23,"phases":614,"briefSummary":615,"conditions":616,"keywords":619,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":50},"100578439","eeg-study-on-neurophysiological-and-psychological-effects-of-ericksonian-hypnotherapy-in-generalized-anxiety-disorder-100578439","NCT06811311","EEG Study on Neurophysiological and Psychological Effects of Ericksonian Hypnotherapy in Generalized Anxiety Disorder","Neurophysiological and Psychological Effects of Ericksonian Hypnotherapy on Generalized Anxiety Disorder: An EEG-Based Clinical Study","EEG-HypnoGAD","Inclusion Criteria:\n\n* Diagnosis of Generalized Anxiety Disorder (GAD) based on DSM-5 criteria\n* Aged 18-65 years\n* Capable of providing written informed consent\n* Fluent in Turkish (for hypnosis and assessments)\n* Not currently receiving psychotherapy or pharmacological treatment for anxiety\n\nExclusion Criteria:\n\n* Presence of comorbid psychiatric disorders (e.g., schizophrenia, bipolar disorder, major depression requiring immediate intervention)\n* History of neurological conditions (e.g., epilepsy, traumatic brain injury, stroke)\n* Current use of medications affecting EEG activity (e.g., benzodiazepines, SSRIs, antipsychotics)\n* Previous experience with hypnotherapy (to avoid expectancy bias)\n* Substance abuse or dependence within the last six months\n* Pregnancy or breastfeeding\n* Severe medical conditions that may interfere with participation",{"count":265,"type":22},[25],"This study examines the neurophysiological and psychological effects of Ericksonian hypnotherapy in individuals diagnosed with Generalized Anxiety Disorder (GAD). Using electroencephalography (EEG), the study aims to assess changes in brain activity and anxiety symptoms before and after treatment.\n\nA total of 60 participants will be recruited from both governmental and private psychiatric clinics in Istanbul. Participants will be randomly assigned to either the intervention group (receiving 12 Ericksonian hypnotherapy sessions over 12 weeks) or the control group (receiving no intervention).\n\nThe primary outcome measures include changes in EEG patterns, specifically alpha, theta, and frontal asymmetry indices, and changes in anxiety severity, measured by the Beck Anxiety Inventory (BAI), Generalized Anxiety Disorder-7 (GAD-7), and State-Trait Anxiety Inventory (STAI). Secondary measures include emotional regulation (DERS) and quality of life (WHOQOL-BREF).\n\nThis study aims to provide scientific evidence on the effectiveness of Ericksonian hypnotherapy as a complementary treatment for GAD and its impact on brain function and emotional well-being.",[28,405,617,618],"Psychophysiological Disorders","Stress-Related Disorders",[620,621,622,623,624],"Ericksonian Hypnotherapy","Hypnosis and Anxiety","EEG Neurophysiology","Anxiety Treatment","Cognitive-Emotional Regulation","2025-02-17",{"date":627,"type":42},"2025-02-20",{"date":629,"type":42},"2025-02-01",{"date":631,"type":22},"2025-09-01",{"name":633,"class":49},"Uskudar University",{"id":635,"slug":636,"hasResults":11,"nctId":637,"briefTitle":638,"officialTitle":638,"acronym":4,"eligibilityCriteria":639,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":640,"targetDuration":4,"studyType":23,"phases":642,"briefSummary":643,"conditions":644,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":652,"locationsCount":4},"100575658","therapeutic-effect-of-neuromodulation-on-anxiety-disorders-by-high-definition-transcranial-electrical-stimulation-100575658","NCT06775145","Therapeutic Effect of Neuromodulation on Anxiety Disorders by High-Definition Transcranial Electrical Stimulation","Inclusion Criteria:\n\n* Age between 18 and 65 years.\n* Diagnosed with Generalized Anxiety Disorder (GAD) by a psychiatrist according to DSM-5 criteria.\n* Hamilton Anxiety Rating Scale (HAM-A) score ≥ 14.\n* Hamilton Depression Rating Scale (HAM-D; 17-item version) score ≤ 17.\n* Has been consistently receiving psychological counseling and\u002For medication with stable types and dosages for at least 6 weeks prior to enrollment; or is deemed unsuitable for medication and\u002For psychological counseling; or refuses medication and\u002For psychological counseling.\n\nExclusion Criteria:\n\n* Received rTMS or any other form of non-invasive brain stimulation techniques within 2 weeks prior to the study and during the study period.\n* Presence of severe neurological disorders (e.g., stroke, brain tumor, epilepsy, organic brain diseases) or psychiatric disorders (e.g., schizophrenia and other psychotic disorders, bipolar disorder, obsessive-compulsive disorder, other types of anxiety disorders, substance abuse).\n* Severe or unstable physiological conditions that may affect the autonomic or central nervous system (e.g., acute gastrointestinal diseases, cardiovascular diseases, thyroid disorders).\n* History of cardiac arrhythmia.\n* Presence of implanted medical electronic devices (e.g., pacemakers).\n* Presence of metallic implants in the head or neck region.\n* Open wounds on the scalp at the site of electrode contact.\n* History of head surgery or significant head trauma that, based on physician evaluation, makes the individual unsuitable for inclusion.\n* Individuals with significant suicide risk (HAM-D Item 3 score on suicidal risk ≥ 3).\n* Presence of immune disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, inflammatory bowel diseases).\n* Individuals with abnormal or heightened sensitivity to electrical stimulation, making them unable to tolerate it.\n* Pregnancy (for female participants: must be postmenopausal or surgically sterilized. Females of childbearing potential must have a negative pregnancy test. Female participants capable of becoming pregnant and their male partners with female partners capable of becoming pregnant must agree to use effective contraception during the trial and for 4 months after the last study intervention, such as oral contraceptives, dual barrier methods, or intrauterine devices, or agree to abstain from sexual activity during this period. Non-childbearing females are defined as those who have undergone bilateral oophorectomy or are postmenopausal).\n* Taking medications that lower the seizure threshold.\n* Alcohol or substance abuse.\n* Convexity skull defects or elevated intracranial pressure.\n* Breastfeeding women.\n* Other conditions deemed unsuitable for transcranial electrical stimulation based on physician evaluation.",{"count":641,"type":22},100,[25],"High-definition transcranial electrical stimulation (HD-tES) is a non-invasive brain neuromodulation technique that applies a small electrical current to the scalp to alter neural excitability and stimulate localized brain activation. Previous clinical trials have explored the use of HD-tES for treating mental health conditions such as depression, anxiety, obsessive-compulsive disorder, and post-traumatic stress disorder. This trial aims to investigate the efficacy and safety of HD-tES in ameliorating anxiety symptoms among patients with generalized anxiety disorder (GAD), thereby validating its potential as a treatment for anxiety disorders.\n\nParticipants will be randomly assigned to one of four HD-tES treatment groups: (1) HD-tES inhibitory waveform (cDC+cTBS) applied to the right dorsolateral prefrontal cortex (DLPFC) for 10 minutes, followed by sham excitatory waveform (aDC+iTBS) stimulation applied to the left DLPFC for 10 minutes. (2) Sham inhibitory waveform (cDC+cTBS) stimulation applied to the right DLPFC for 10 minutes, followed by HD-tES excitatory waveform (aDC+iTBS) applied to the left DLPFC for 10 minutes. (3) HD-tES inhibitory waveform (cDC+cTBS) applied to the right DLPFC for 10 minutes, followed by HD-tES excitatory waveform (aDC+iTBS) applied to the left DLPFC for 10 minutes. (4) Sham inhibitory waveform (cDC+cTBS) stimulation applied to the right DLPFC for 10 minutes, followed by sham excitatory waveform (aDC+iTBS) stimulation applied to the left DLPFC for 10 minutes. Regardless of the group assignment, participants will undergo treatment sessions over a 2-week period, with five sessions per week and no more than one session per day. Each session lasts approximately 20 minutes. Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.",[28],"2025-01-09",{"date":647,"type":42},"2025-01-14",{"date":649,"type":22},"2025-02-03",{"date":651,"type":22},"2025-12-31",{"name":653,"class":49},"National Taiwan University Hospital"]