ActiveNANCT07542561

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

ConditionSubclinical Depression, Subclinical Anxious Adults, Subclinical Emotional Distress
InterventionArtificial Intelligence-Assisted Internet-Based Mindfulness Intervention
PhaseNA
StatusActive
Participants550
Est. Completion15 Apr 2029
Last Updated25 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

China
View Registry Entry

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