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NOT YET RECRUITING
NCT07840469
NA

A Persian AI-Based CBT Chatbot and Voice Analysis System for Managing Perceived Stress

Sponsor: Hamid Reza Marateb

View on ClinicalTrials.gov

Summary

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. A 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-10-05

Completion Date

2027-02-01

Last Updated

2026-09-25

Healthy Volunteers

No

Interventions

BEHAVIORAL

Persian AI-Based CBT Chatbot

A Persian-language artificial intelligence-based conversational intervention designed to provide structured support based on cognitive behavioral therapy principles for adults with mild to moderate perceived stress. The chatbot delivers interactive CBT-based exercises, including psychoeducation, identification and restructuring of maladaptive thoughts, coping strategies, behavioral techniques, and stress-management exercises. The intervention is delivered during a 14-day period and incorporates predefined safety guardrails and crisis-management procedures.

BEHAVIORAL

Active Mental Health Content

Structured, non-adaptive mental health and stress-management educational content provided during the study period. The content is designed to provide general psychoeducation and stress-management support without personalized AI-generated dialogue or adaptive CBT interaction.

Locations (1)

Isfahan University of Medical Sciences

Isfahan, Isfahan, Iran