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Effectiveness Evaluation of a Large Language Model-Based Online Cognitive Behavioral Therapy System for Adolescents with Depression

Effectiveness Evaluation of a Large Language Model-Based Online Cognitive Behavioral Therapy System for Adolescents with Depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113680
Enrollment
Unknown
Registered
2025-12-02
Start date
2024-11-08
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Depression

Interventions

Intervention group:The intervention group will receive a 4-week, smartphone-based, self-guided CBT intervention delivered via a large language model, once daily for approximately 10 minutes per sessio
Gontrol group:After completing the baseline assessment, the control group will access the same intervention system developed for this study as the intervention group
however, participants in the control group will only complete weekly assessments and will not receive any CBT-related interventions. Similar to the intervention group, the control group will undergo a

Sponsors

Beijing Huilongguan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Meet the DSM-V diagnostic criteria for depressive disorder or depressive episode; 2. Assessed by a physician to be in mild to moderate depressive state, with no suicide risk, and either refusing pharmacological or physical therapy (with agreement from patient and family), or in a stable phase of pharmacological treatment; 3. Age between 12 and 18 years; 4. PHQ-9 score >=10 on screening; 5. Educational level of elementary school or higher; 6. Proficient in using smartphones; 7. Possess an independent WeChat account; 8. Voluntarily participate in the study, with both the adolescent and their parent(s) providing signed informed consent and agreeing to participate in follow-up interviews.

Exclusion criteria

Exclusion criteria: 1. History of severe somatic or neurological disorders (e.g., traumatic brain injury, epileptic seizures); 2. Diagnosis of any other psychiatric disorder besides depressive disorder or depressive episode, as determined by diagnostic assessment using the DSM-5 criteria; 3. History of a strong suicide attempt or any suicidal behavior within the past month; 4. Presence of auditory and/or visual perceptual impairments; 5. Difficulty with Chinese reading.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale (HAMD);Generalized Anxiety Disorder Questionnaire-7 (GAD-7);Insomnia Severity Index questionnaire (ISI);

Secondary

MeasureTime frame
Hamilton Anxiety Scale (HAMA);Patient Health Questionnaire-9 (PHQ-9);Positive and negative affect scale (PANAS);Symbol Search (SS);

Countries

China

Contacts

Public ContactTan Shuping

Beijing Huilongguan Hospital

shupingtan@126.com+86 186 0050 1332

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026