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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
550
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).
Peking University
Beijing, Beijing Municipality, China
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).
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.
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).
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.
Treatment Inventory of Costs in Patients with Psychiatric Disorders (TIC-P)
TIC-P is a widely used health economic instrument in mental health research for assessing psychiatric healthcare use and societal costs, including service utilization, medication use, and productivity losses (Bouwmans et al., 2013). In this study, TIC-P will be used to record healthcare resource consumption during the trial, including outpatient visits, medication costs, and other healthcare-related expenditures. To capture healthcare utilization more comprehensively, a self-developed healthcare utilization questionnaire will also be administered.
Time frame: 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)
This is one of the most widely used instruments in health economic evaluation for measuring health-related quality of life and includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five response levels (Devlin \& Brooks, 2017; Herdman et al., 2011). The health utility values derived from EQ-5D-5L will be used to calculate Quality-Adjusted Life Years (QALYs) for cost-utility analysis (Drummond et al., 2015; Group, 1990).
Time frame: 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)
Resilience will be measured using the Connor-Davidson Resilience Scale (CD-RISC), one of the most widely used instruments for assessing the ability to cope with stress and adversity, with good reliability and validity (Connor \& Davidson, 2003).
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.
the Perceived Stress Scale (PSS)
Perceived stress will be measured using the Perceived Stress Scale (PSS), a widely used instrument that assesses individuals' subjective appraisal of stress over a recent period (Cohen et al., 1983).
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.
the Satisfaction With Life Scale (SWLS)
Life satisfaction will be measured using the Satisfaction With Life Scale (SWLS), which assesses individuals' cognitive evaluation of their overall life circumstances and has sound psychometric properties (Diener et al., 1985).
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.
the Insomnia Severity Index (ISI)
Sleep status will be assessed using the Insomnia Severity Index (ISI), a brief 7-item self-report scale widely used in clinical and digital health research to assess the severity of insomnia symptoms and their impact on daily functioning (Bastien et al., 2001; Morin et al., 2011).
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.
Overall Anxiety Severity and Impairment Scale (OASIS)
The OASIS is a 5-item self-report measure designed to assess the frequency and severity of anxiety symptoms, as well as the extent of anxiety-related functional impairment and avoidance, over the past week. Each item is rated on a 5-point scale from 0 to 4, with total scores ranging from 0 to 20. Higher scores indicate greater overall anxiety severity and impairment. The OASIS has demonstrated good reliability and validity in both clinical and nonclinical samples (Norman et al., 2006).
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.
Overall Depression Severity and Impairment Scale (ODSIS)
The ODSIS is a 5-item self-report measure designed to assess the frequency and severity of depressive symptoms, as well as depression-related functional impairment and avoidance, over the past week. Each item is rated on a 5-point scale from 0 to 4, with total scores ranging from 0 to 20. Higher scores indicate greater overall depression severity and impairment. The ODSIS has demonstrated good reliability and validity in both clinical and nonclinical samples (Bentley et al., 2014).
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.
the Five Facet Mindfulness Questionnaire (FFMQ)
Mindfulness will be assessed using the Five Facet Mindfulness Questionnaire (FFMQ). The FFMQ measures trait mindfulness across five dimensions: observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience. It is one of the most widely used instruments in mindfulness research and has demonstrated good reliability and validity (Baer et al., 2006). In this study, the total FFMQ score and its subscale scores will be analyzed as exploratory continuous variables
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.
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