AI-Assisted Mindfulness Intervention in Emotional Distress

NCT07542561 | Not Yet Recruiting

• 1 other identifier: E20260331
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

artificial intelligence-assisted intervention; internet-based mindfulness intervention; emotional distress; subclinical anxiety and depression

Outcome Measures

Primary Outcomes (2)

• Generalized Anxiety Disorder-7 (GAD-7)

  The GAD-7 is a 7-item self-report questionnaire used to assess the severity of anxiety symptoms over the past 2 weeks. Each item is rated on a 4-point scale from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 21. Higher scores indicate greater anxiety severity. The GAD-7 has demonstrated good reliability and validity in both clinical and general populations (Spitzer et al., 2006).

  Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.

• Patient Health Questionnaire-9 (PHQ-9)

  The PHQ-9 is a 9-item self-report questionnaire used to assess the severity of depressive symptoms over the past 2 weeks. Each item is rated on a 4-point scale from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 27. Higher scores indicate greater depression severity. The PHQ-9 has demonstrated good reliability and validity in both clinical and general populations (Kroenke et al., 2001).

  Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.

Secondary Outcomes (9)

• Treatment Inventory of Costs in Patients with Psychiatric Disorders (TIC-P)

  Baseline (T0); immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.

• EuroQol 5-Dimension 5-Level (EQ-5D-5L)

  Baseline (T0); immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.

• the Connor-Davidson Resilience Scale (CD-RISC)

  Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.

• the Perceived Stress Scale (PSS)

  Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.

• the Satisfaction With Life Scale (SWLS)

  Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.

Other Outcomes (10)

• the Engaging in Life Scale

  Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.

• the Distress Tolerance Scale (DTS)

  Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.

• the Discomfort Intolerance Scale (DIS)

  Time Frame: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.

Study Arms (2)

iMIED

EXPERIMENTAL

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

WL

NO INTERVENTION

Interventions

Artificial Intelligence-Assisted Internet-Based Mindfulness Intervention COMBINATION_PRODUCT

Delivered via the internet, the intervention is grounded in the Psychopathology Diamond Model proposed by Liu Xinghua's team. It integrates four core strategies: increasing engagement in life, enhancing distress tolerance, reducing excessive emotional behavior, and improving cognitive flexibility (Liu, 2024). Based on advanced large language models, including Tencent Hunyuan and DeepSeek R1, and supported by an official MIED knowledge base comprising the "Mindfulness Practice" WeChat public account, supervision Q\&A records, and other official materials produced by Liu Xinghua and colleagues, the team developed an AI assistant called the "MIED Mindfulness Assistant," along with a WeChat self-help mini-program. Together, these tools support participants' learning and practice over a 49-day continuous training period (Liu, 2024).

iMIED

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xinghua Liu: lead

Study Sites (1)

Peking University

Beijing, Beijing Municipality, 100871, China

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Yinan Zhang, PHD Candidate

CONTACT

8615823339524; yinanzhang25@stu.pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 21, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): April 15, 2029
• Study Completion (Estimated): May 15, 2029
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)