Artificial Intelligence-Assisted Internet-Based Mindfulness Intervention for Emotional Distress: Protocol for a Randomized Controlled Trial on Long-Term Outcomes and Cost-Effectiveness
Sponsor: Xinghua Liu
Trial Details
| Condition | Subclinical Depression, Subclinical Anxious Adults, Subclinical Emotional Distress |
| Intervention | Artificial Intelligence-Assisted Internet-Based Mindfulness Intervention |
| Phase | NA |
| Status | Active |
| Participants | 550 |
| Est. Completion | 15 Apr 2029 |
| Last Updated | 25 June 2026 |
Primary Outcome
Generalized Anxiety Disorder-7 (GAD-7); Patient Health Questionnaire-9 (PHQ-9)
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: Aged 18 to 65 years PHQ-9 or GAD-7 score ≥5 Able to use a smartphone or other internet-enabled electronic device and possessing sufficient digital literacy to participate in the online intervention and complete follow-up assessments Willing to participate and able to provide informed consent Exclusion Criteria: Current psychotic disorder or bipolar disorder Current organic mental disorder, pervasive developmental disorder, severe cognitive impairment, or substance use disorder Current suicide risk, defined as a score of ≥2 on Item 9 of the PHQ-9 Previous participation in a structured 8-week mindfulness course or the 49-day self-guided course developed by the Peking University Mindfulness Laboratory
Trial Sites
Countries
This content is for educational purposes for healthcare professionals only and does not constitute clinical advice. Clinical decisions should be based on individual patient assessment, current guidelines, and appropriate specialist consultation. Editorial Standards · Privacy Policy · Terms of Service