AI-Assisted Mindfulness Intervention in Emotional Distress

Xinghua Liu

Status

Not yet enrolling

Conditions

Subclinical Anxious Adults

Subclinical Depression

Subclinical Emotional Distress

Treatments

Combination Product: Artificial Intelligence-Assisted Internet-Based Mindfulness Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT07542561

E20260331

Details and patient eligibility

About

The goal of this clinical trial is to learn whether an artificial intelligence-assisted internet-based mindfulness intervention for emotional distress (iMIED) can prevent or reduce anxiety and depressive symptoms in adults with subclinical emotional distress. The main questions it aims to answer are:

Can iMIED reduce anxiety symptoms, as measured by the Generalized Anxiety Disorder-7 (GAD-7)? Can iMIED reduce depressive symptoms, as measured by the Patient Health Questionnaire-9 (PHQ-9)?

Researchers will compare participants receiving iMIED plus access to usual mental health resources with participants receiving usual mental health resources alone to see whether iMIED leads to greater improvement in emotional distress over time.

Participants will:

complete online screening and baseline assessments; be randomly assigned to either the iMIED intervention group or the control group; if assigned to the intervention group, complete a 49-day AI-assisted online mindfulness self-help program using a WeChat mini-program and AI support tool; complete follow-up online questionnaires during the intervention and at 3, 6, 12, 18, and 24 months after the intervention; report information on mental health symptoms, quality of life, healthcare use, sleep, stress, resilience, and life satisfaction.

Enrollment

550 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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