[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606577":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":35,"locations":35,"responsibleParty":36,"collaborators":35,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":40,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":35,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":70,"whyStopped":35,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":35},{"fullName":5,"class":6},"National Health Research Institutes, Taiwan","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TAU + ICBT","EXPERIMENTAL","Participants will receive standard psychiatric care (Treatment as Usual, TAU) plus an 8-week Internet-based Cognitive Behavioral Therapy (ICBT) program delivered via the National Health Research Institutes platform.",[13],"Behavioral: Internet-Based Cognitive Behavioral Therapy (ICBT)",{"label":15,"type":16,"description":17,"interventionNames":18},"TAU Only","ACTIVE_COMPARATOR","Participants will receive standard psychiatric care (TAU) without ICBT during the study period. After study completion, they may request access to the ICBT program.",[19],"Other: Treatment as Usual (TAU) Only",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Internet-Based Cognitive Behavioral Therapy (ICBT)","An 8-week Internet-based Cognitive Behavioral Therapy (ICBT) program delivered via the National Health Research Institutes (NHRI) secure online platform. The program consists of 12 sequential modules released every 5 days, covering core CBT techniques such as cognitive restructuring, emotion regulation, behavioral activation, mindfulness, and self-compassion. Participants receive automated email notifications for new modules and supplementary review materials. Progress is monitored through the platform, and participants complete standardized self-report assessments at baseline, mid-intervention (week 5), post-intervention (week 9), and 3-month follow-up.",[9],[27,28],"Online CBT","Web-based CBT",{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Treatment as Usual (TAU) Only","Routine clinical care provided by a psychiatrist, which may include pharmacological treatment, psychoeducation, and regular follow-up visits according to clinical judgment. No ICBT intervention is provided during the study period. Participants follow the same assessment schedule as the experimental group. After the 3-month follow-up, participants in this group may request access to the ICBT program.",[15],[34],"Standard Psychiatric Care",null,{"type":37,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100606577","internet-based-cognitive-behavioral-therapy-with-treatment-as-usual-for-generalized-anxiety-disorder-and-major-depressive-disorder-in-taiwan-icbt-tw-100606577",false,"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).","ALL","20 Years","65 Years",{"count":50,"type":51},120,"ESTIMATED","INTERVENTIONAL",[54],"NA","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.",[57,58],"Generalized Anxiety Disorder (GAD)","Major Depressive Disorder (MDD)",[60,61,62,63,64,65,66,67,68,69],"Internet-Based Cognitive Behavioral Therapy","ICBT","Digital Mental Health","Online Therapy","Randomized Controlled Trial","Cognitive Restructuring","Mindfulness","Self-Compassion","Taiwan","Treatment as Usual (TAU)","NOT_YET_RECRUITING","2025-09-17",{"date":73,"type":74},"2025-09-22","ACTUAL",{"date":76,"type":51},"2025-09-20",{"date":78,"type":51},"2026-06-30",{"name":5,"class":6}]