[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621066":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":23,"studyPopulation":23,"armGroups":32,"interventions":43,"overallOfficials":49,"centralContacts":53,"locations":63,"responsibleParty":89,"collaborators":23,"id":92,"slug":23,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":23,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":121,"whyStopped":23,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Universiti Putra Malaysia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":23},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Generalized Anxiety Disorder Scale","The GAD-7 is a 7-item self-report measure used to assess the frequency and severity of anxiety symptoms in clients 11 and older. Aligned with the DSM-V-TR criteria for Generalized Anxiety Disorder (GAD) the results of this measure can support accurate diagnoses, establishment of treatment goals based on symptom severity, and guide effective clinical interventions.\n\nScores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.\n\nUsing the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for GAD. It is moderately good at screening three other common anxiety disorders - panic disorder (sensitivity 74%, specificity 81%), social anxiety disorder (sensitivity 72%, specificity 80%) and post-traumatic stress disorder (sensitivity 66%, specificity 81%).","Baseline, post-intervention at 1 month, and follow-up at one month post-intervention.",{"measure":14,"description":15,"timeFrame":12},"Patient Health Questionnaire","The PHQ-9 is a widely recognized self-report questionnaire used to screen for depression severity. It's a simple yet powerful tool, comprising nine questions that mirror the nine diagnostic criteria for major depressive disorder from the DSM-IV. Understanding how to score phq 9 is the first step in interpreting your results.\n\nA score of ≥10 is considered a sensitive and specific cut-off for major depressive disorder. Whereas, a score ≥15 strongly indicates the presence of clinically significant depression.",{"measure":17,"description":18,"timeFrame":12},"Automatic Thoughts Questionnaire","The ATQ is a psychological assessment tool designed to measure the frequency of negative automatic thoughts, particularly in individuals with depression.\n\nATQ consists of 30 items, each describing a common negative automatic thought relevant to depression, such as \"I am a failure\" or \"I can't cope.\" Respondents rate how frequently they have experienced each thought over a specified period, typically the past week, using a structured Likert scale. This systematic approach transforms fleeting internal experiences into quantifiable data points.",[20],{"measure":21,"description":22,"timeFrame":12},"World Health Organization Quality of Life-BREF","WHOQOL-BREF is a self-report questionnaire that contains 26 items and addresses 4 QOL domains: physical health (7 items), psychological health (6 items), social relationships (3 items) and environment (8 items). Two other items measure overall QOL and general health.\n\nItems are rated on a 5-point Likert scale (low score of 1 to high score of 5) to determine a raw item score. Subsequently, the mean score for each domain is calculated, resulting in a mean score per domain that is between 4 and 20. Finally, this mean domain score is then multiplied by 4 in order to transform the domain score into a scaled score, with a higher score indicating a higher QOL.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":29,"maskingDescription":23,"whoMasked":30},"SINGLE",[31],"PARTICIPANT",[33,39],{"label":34,"type":35,"description":36,"interventionNames":37},"Experimental Group","EXPERIMENTAL","The experimental group will be provided with 4 weeks intervention, one hour each, followed by one booster session at 1 month post-intervention.",[38],"Behavioral: DARE-Depression and Anxiety Regulation Program",{"label":40,"type":41,"description":42,"interventionNames":23},"Waitlist Control Group","NO_INTERVENTION","The waitlist control group will be provided with 4 weeks intervention, one hour each, followed by one booster session at 1 month post-intervention.",[44],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":23},"BEHAVIORAL","DARE-Depression and Anxiety Regulation Program","Participants assigned to this intervention will receive a structured, manual-based online GCCBT intervention delivered via Zoom. The program consists of four weekly group sessions, each lasting approximately 60 minutes, followed by a booster session conducted one month after completion of the intervention.\n\nSessions will be conducted by the researcher, a clinical psychologist, under the supervision of a senior clinical psychologist with formal training and expertise in group Cognitive Behavioral Therapy (GCBT). The intervention follows a structured progression beginning with psychoeducation, followed by cognitive skill development and behavioural techniques. The later sessions emphasise consolidation of learnt skills, peer support, and relapse-prevention planning.\n\nThe content and delivery of the intervention are designed to be relevant and sensitive to the experiences of international university students.",[34],[50],{"name":51,"affiliation":5,"role":52},"Prof. Dr. Firdaus Mukhtar","STUDY_CHAIR",[54,59],{"name":55,"role":56,"phone":57,"phoneExt":23,"email":58},"Shamsa Riaz, PhD Researcher","CONTACT","+60176929270","gs70161@student.upm.edu.my",{"name":60,"role":56,"phone":61,"phoneExt":23,"email":62},"Prof. Dr. Firdaus Mukhtar, PhD Clinical Psychology","+6012-302 6353","drfirdaus@upm.edu.my",[64],{"facility":65,"status":23,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Universiti Putra Malaysia (UPM)","Serdang","Selangor","43400","Malaysia","MY",{"type":72,"coordinates":73},"Point",[74,75],101.71667,3.03333,{"lat":75,"lon":74},[78,82,86],{"name":79,"role":56,"phone":80,"phoneExt":23,"email":81},"School of Graduate Studies (SGS), UPM","+603-9769 1000","pspk@upm.edu.my",{"name":83,"role":56,"phone":84,"phoneExt":23,"email":85},"Ethics Committee for Research Involving Human Subjects (JKEUPM","03-97691244\u002F1421\u002F1438\u002F1439","jkeupm@upm.edu.my",{"name":87,"role":88,"phone":23,"phoneExt":23,"email":23},"Shamsa Riaz, PhD Candidate","PRINCIPAL_INVESTIGATOR",{"type":88,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Shamsa Riaz","PhD Candidate","100621066",false,"NCT07365787","Internet-Based Group CBT for Anxiety and Depression Among International Students","Effectiveness of Internet-Based Group Cognitive Behaviour Therapy (GCBT) for Anxiety and Depression Among International Students Studying in Malaysia: A Randomized Controlled Trial","DARE Program","Inclusion Criteria:\n\n* International students.\n* 18 and 60 years of age.\n* Moderate to severe symptoms of anxiety and depression.\n* Fluent in the English language.","ALL","18 Years","60 Years",{"count":103,"type":104},128,"ESTIMATED","INTERVENTIONAL",[107],"NA","The goal of this RCT trial is to learn if internet-based group cognitive behaviour therapy delivered via the Zoom application works to treat anxiety and depression among international students. It will also learn about the predictive factors of the intervention's effectiveness. The main questions it aims to answer are:\n\n* Does participating in internet-based GCBT reduce the symptoms of anxiety among international students in Malaysia?\n* Does participating in internet-based GCBT reduce the symptoms of depression among international students in Malaysia?\n\nResearchers will compare students who take part in the intervention program with students in a waitlist control group to understand whether the intervention is associated with changes in anxiety and depression symptoms.\n\nParticipants will:\n\n* Be randomly assigned to either the intervention program or a waitlist control group\n* Attend four sessions of one hour each, including 1) psychoeducation, 2) cognitive techniques, 3) behaviour techniques, and 4) support and relapse prevention. A booster session and a follow-up assessment will be done1 month post intervention.",[110,111],"Anxiety","Depression",[110,111,113,114,115,116,117,118,119,120],"Anxiety and Depression","Internet-based Group Cognitive Behaviour Therapy","Internet-based Group CBT","Internet-based Group CBT Intervention","iGCBT","Internet-based GCBT","International Students","University Students","NOT_YET_RECRUITING","2026-01-28",{"date":124,"type":125},"2026-01-30","ACTUAL",{"date":127,"type":104},"2026-06-01",{"date":129,"type":104},"2027-08-31",{"name":5,"class":6},1]