[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hamid Reza Marateb\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100657636","a-persian-ai-based-cbt-chatbot-and-voice-analysis-system-for-managing-perceived-stress-100657636",false,"NCT07840469","A Persian AI-Based CBT Chatbot and Voice Analysis System for Managing Perceived Stress","Design and Evaluation of an Intelligent Mental Health System Based on Voice Analysis and an Empathetic Cognitive Behavioral Therapy (CBT) Chatbot for Perceived Stress Management: A Three-Arm Pilot Randomized Controlled Trial","PersianAI-CBT","Inclusion Criteria:\n\n* Age between 18 and 45 years\n* Mild or moderate perceived stress based on the Perceived Stress Scale-10 (PSS-10) screening assessment\n* Ability to use a smartphone\n* Access to the internet during the study period\n* Ability and willingness to provide electronic informed consent\n* Willingness to participate in study assessments and complete the required study procedures\n\nExclusion Criteria:\n\n* Severe perceived stress at the initial screening assessment\n* Active suicidal ideation or risk of self-harm\n* Acute psychological crisis requiring immediate professional intervention\n* Active psychosis\n* Active mania\n* Severe substance use disorder\n* Psychiatric hospitalization in recent months\n* Initiation of a new psychiatric medication or change in the dose of a psychiatric medication within the previous four weeks\n* Concurrent participation in intensive psychotherapy or another intensive psychological intervention\n* Any mental health condition requiring immediate specialist evaluation or treatment","ALL","18 Years","45 Years",{"count":21,"type":22},120,"ESTIMATED","INTERVENTIONAL",[25],"NA","This pilot randomized controlled trial aims to evaluate a Persian-language artificial intelligence (AI)-based cognitive behavioral therapy (CBT) chatbot designed to support adults in managing perceived stress.\n\nA total of 120 adults will be randomly assigned to one of three groups: an AI-based CBT chatbot intervention, active mental health educational content, or a waitlist control. The intervention period will last 14 days. The study will evaluate the feasibility, acceptability, safety, and preliminary effectiveness of the AI-based CBT chatbot for perceived stress management. As a separate research component, voice recordings will be collected from participants at baseline and at the end of the study. These recordings will be used solely as research data to train and evaluate an artificial intelligence model for stress detection. The voice-based model will not be used to guide, modify, personalize, or influence the study intervention, chatbot responses, participant allocation, or clinical decision-making during this trial.",[28,29],"Psychological Stress","Perceived Stress",[31,32,33,34],"Stress Management","Large Language Model","AI Chatbot","Digital Mental Health","NOT_YET_RECRUITING","2026-09-24",{"date":38,"type":39},"2026-09-25","ACTUAL",{"date":41,"type":22},"2026-10-05",{"date":43,"type":22},"2027-02-01",{"name":45,"class":46},"Hamid Reza Marateb","OTHER",""]