Therapeutic Factors of Generative AI in Digital Psychological Interventions: Integrating Common Factors and AI-Specific Mechanisms

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600122417

Enrollment

Unknown

Registered

2026-04-13

Start date

2026-04-13

Completion date

Unknown

Last updated

2026-04-20

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

Conditions

Emotional disorders

Interventions

AI+UP Intervention Group:WeChat mini-program integrated with Claude Opus 4.6 large model, based on UP (cross-diagnostic unified protocol) approach, including 8 structured modules (emotional awareness,

intervention duration of 4 weeks (28 days)

Waitlist Control Group:Waitlist period (no intervention)

full intervention opportunity provided after waitlist period (before study end)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 60 years; 2. A score of >= 5 on the PHQ-9 or GAD-7 (indicating the presence of anxiety or depressive symptoms); 3. Proficient in using smartphones and Mini-programs, with fluent reading and writing capabilities; 4. Voluntarily participate and provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. A score of > 0 on item 9 of the PHQ-9 (suicidal ideation) at baseline, or identified risk of self-harm or suicide during the experiment; 2. A history or current diagnosis of schizophrenia, bipolar disorder, or psychotic symptoms; 3. Currently receiving other high-intensity psychological counseling or taking psychotropic medications; 4. A history of alcohol or substance abuse.

Design outcomes

Primary

Measure	Time frame
Depressive Symptoms;Anxiety Symptoms;Safety Outcomes (including user-side high-risk events such as suicidal/self-harm intent, and AI-side generated risks such as medical boundary violations, inducement of harm, etc.);	—

Secondary

Measure	Time frame
Real Relationship Inventory - Client Version (RRI-C);Working Alliance Inventory - Short Revised (WAI-SR);Credibility and Expectancy Questionnaire (CEQ);Treatment Engagement;AI-specific Factors (Accessibility, De-socialization, Technological Trustworthiness, Perceived Personalization, Favorability, Non-judgmental Attitude, Privacy Protection, AI Bias, Perceived Safety Risk);	—

Countries

China

Contacts

Public ContactAn Benpengzi

Faculty of Psychology, Beijing Normal University

k.kishimoto@bnu.edu.cn+86 159 1066 5207

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026