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Evaluation of the Effectiveness of Generative AI (Gen-AI) Virtual Chatbot Digital Humans in Psychological Counseling and Optimization of Intervention Strategies

Evaluation of the Effectiveness of Generative AI (Gen-AI) Virtual Chatbot Digital Humans in Psychological Counseling and Optimization of Intervention Strategies: A Randomized Controlled Trial Based on Hospital Outpatient Settings

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123050
Enrollment
Unknown
Registered
2026-04-21
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mental disorder

Interventions

experimental group:Gen-AI virtual chatbot digital human counseling
control group 1:human psychological counseling
control group 2:bibliotherapy

Sponsors

?Shenzhen Longgang District Center for Disease Control and Prevention of Chronic Diseases
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18–60 years; 2. PHQ-9 = 9 or GAD-7 = 9, and does not meet the diagnostic criteria for severe mental disorders; 3. Voluntarily participates in the study; 4. Has good cognitive and communication abilities; 5. Able to fully participate in the counseling sessions and cooperate with subsequent follow-up assessments.

Exclusion criteria

Exclusion criteria: 1. Those who have previously received systematic psychotherapy; 2. Those clinically diagnosed with severe mental disorders or severe psychological illnesses; 3. Those with tendencies toward self-harm/suicide, somatization, or hostility; 4. Those unwilling to participate in this study; 5. Those with severe physical illnesses that make them unsuitable for participation in this study; 6. Those deemed unsuitable by researchers for other reasons.

Design outcomes

Primary

MeasureTime frame
Patient Health Questionnaire-9, PHQ-9;General Anxiety Disorder 7-Item Scale, GAD-7;Pittsburgh sleep quality indexs, PSQI;the Multidimensional Scale of Perceived Social Support, MSPSS;

Secondary

MeasureTime frame
Working Alliance inventory-short revised, WAI-SR;satisfaction evaluation;

Countries

China

Contacts

Public ContactWang He

?Shenzhen Longgang District Center for Disease Control and Prevention of Chronic Diseases

573135021@qq.com+86 136 6262 4760

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026