AI Mindfulness for Emotional Distress Trial
ClinicalTrials.gov Studies
Summary
NIH's ClinicalTrials.gov has registered NCT07542561, a randomized clinical trial evaluating whether an artificial intelligence-assisted internet-based mindfulness intervention (iMIED) can reduce anxiety and depressive symptoms in adults with subclinical emotional distress. Participants will be assigned to iMIED plus usual mental health resources or to usual resources alone, with follow-up assessments at 3, 6, 12, 18, and 24 months after the intervention. The trial uses a WeChat mini-program and AI support tool delivered over a 49-day period.
“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.”
What changed
This document registers a clinical trial (NCT07542561) on ClinicalTrials.gov, describing a randomized controlled study of an AI-assisted internet-based mindfulness intervention targeting adults with subclinical emotional distress. The trial compares iMIED plus usual mental health resources against usual resources alone across a 24-month follow-up period. Clinical investigators and institutional review boards should note the trial design and endpoints (GAD-7 and PHQ-9), but this registration imposes no compliance obligations on healthcare providers, employers, or technology companies beyond standard clinical research requirements.
Healthcare providers and digital health companies offering or developing AI-assisted mental health tools should monitor this trial's outcomes. Trial results may inform future guidance on AI-based self-help interventions for subclinical emotional distress. No regulatory reporting or policy changes are triggered by this registration alone.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
AI-Assisted Mindfulness Intervention in Emotional Distress
N/A NCT07542561 Kind: NA Apr 21, 2026
Abstract
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.
Conditions: Subclinical Depression, Subclinical Anxious Adults, Subclinical Emotional Distress
Interventions: Artificial Intelligence-Assisted Internet-Based Mindfulness Intervention
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