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Mindfulness Intervention for Emotional Distress (MIED) in Patients With GERD

5 september 2026 bijgewerkt door: Xinghua Liu

Effects of an Online Mindfulness-Based Emotion Intervention on Symptoms and Emotional Distress in Patients With Gastroesophageal Reflux Disease: A Multicenter Randomized Waitlist-Controlled Trial

The goal of this multicenter randomized waitlist-controlled clinical trial is to evaluate whether an online Mindfulness-Based Intervention for Emotional Distress (MIED) can reduce emotional distress and reflux-related symptoms in adults with gastroesophageal reflux disease (GERD). GERD is a common chronic gastrointestinal condition that is frequently accompanied by anxiety, depressive symptoms, stress, and impaired quality of life.

The main questions this study aims to answer are:

Can online MIED reduce emotional distress in patients with GERD?

Can online MIED reduce reflux-related symptoms and improve reflux-related quality of life?

Are changes in psychological processes, such as distress tolerance, cognitive flexibility, experiential avoidance, emotional behaviors, and life engagement, associated with improvements in emotional distress and reflux symptoms?

Researchers will compare participants receiving online MIED with participants in a waitlist control group receiving usual medical care and health management to determine whether online MIED leads to greater improvement over time.

Participants will:

complete screening and baseline assessments;

be randomly assigned to either the online MIED intervention group or the waitlist control group;

if assigned to the intervention group, complete an 8-week online MIED program with one session per week;

continue necessary usual medical care during the study, while keeping medication use stable when possible;

complete online questionnaires at baseline, during the intervention, after the intervention, and at 3, 6, 12, and 24 months after the intervention;

report information on reflux symptoms, emotional distress, quality of life, sleep, stress, resilience, life satisfaction, healthcare use, intervention adherence, and adverse events.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

500

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100871
        • Werving
        • Peking University
      • Beijing, Beijing Municipality, China, 100080
        • Werving
        • Being Haidian Hospital
        • Contact:
      • Beijing, Beijing Municipality, China, 100088
        • Werving
        • PLA Rocket Force Characteristic Medical Center
        • Contact:
    • Gansu
      • Baiyin, Gansu, China, 730913
        • Werving
        • Baiyin Central Hospital
        • Contact:
    • Guangdong
      • Shenzhen, Guangdong, China, 518036
        • Werving
        • Peking University Shenzhen Hospital
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China, 550004
        • Nog niet aan het werven
        • the first affiliated hospital of GuiZhou medical university
        • Contact:
    • Hebei
      • Xingtai, Hebei, China, 054899
        • Nog niet aan het werven
        • Center Hospital Qinghe County
        • Contact:
      • Xinle, Hebei, China, 050700
        • Werving
        • Xinle City Hospital
        • Contact:
    • Inner Mongolia
      • Chifeng, Inner Mongolia, China, 024000
        • Werving
        • Affiliated Houspital of Chifeng University
        • Contact:
      • Hohhot, Inner Mongolia, China, 026000
        • Werving
        • Xilingol League Mongolian Medicine Hospital
        • Contact:
          • Yinghai Yang, MBBS
          • Telefoonnummer: 86+13947955766
          • E-mail: yyh0479@163.com
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Werving
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250022
        • Werving
        • Shandong Second Provincial General Hospital
        • Contact:
      • Liaocheng, Shandong, China, 252600
        • Werving
        • the Second People's Hospital of Liaocheng
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200233
        • Werving
        • Shanghai Sixth People's Hospital
        • Contact:
    • Shanxi
      • Changzhi, Shanxi, China, 046000
        • Nog niet aan het werven
        • Changzhi People'S Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria

Participants must meet all of the following criteria:

  1. Aged 18 to 65 years.
  2. GERD-Q score of 8 or higher.
  3. Willingness to maintain a relatively stable usual treatment regimen during the study unless medically indicated changes are required.
  4. Ability to use a smartphone, computer, or tablet to participate in the online program and complete online questionnaires.
  5. Willingness to comply with course training and follow-up assessments.
  6. Ability to understand the study and provide written or electronic informed consent.

Exclusion Criteria

Participants meeting any of the following criteria will be excluded:

  1. Alarm symptoms or high suspicion of serious organic disease, including but not limited to progressive dysphagia, hematemesis, melena, unexplained weight loss, anemia, recurrent vomiting, or persistent chest pain without exclusion of cardiovascular risk.
  2. Current or previous severe esophageal organic disease or gastrointestinal malignancy.
  3. History of anti-reflux surgery, partial gastrectomy, or other upper gastrointestinal surgery that may substantially affect reflux symptom assessment.
  4. GERD-Q score greater than 15, or symptoms judged by the study physician to be extremely severe and requiring priority medical evaluation or intensified treatment.
  5. Current uncontrolled severe mental disorder, such as schizophrenia, manic episode of bipolar disorder, acute severe depressive episode, or severe substance use disorder.
  6. Current suicide risk, operationalized as a score greater than 1 on item 9 of the PHQ-9.
  7. Previous systematic participation in MIED, mindfulness-based stress reduction, mindfulness-based cognitive therapy, or another structured mindfulness program.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: MIED
The intervention is delivered via the internet and is grounded in the psychopathological diamond model of emotional distress proposed by Liu and colleagues. The program is supported by a MIED knowledge base, the Mindfulness Study public account, supervision and question-answer records, and official materials from Liu Xinghua and the MIED team. These resources are integrated into a WeChat self-help mini-program and the MIED Mindfulness Assistant, an artificial intelligence-supported system developed using large language models such as Tencent Hunyuan and DeepSeek R1. Together, these tools support participants' learning and practice over a continuous 49-day training period.
Ander: TAU
Participants will continue usual GERD treatment and health management during the 49-day observation period. They will not receive MIED, mindfulness training, or other structured psychological interventions during this period. Usual care may include medication, lifestyle advice, and necessary follow-up as determined by clinicians. The waitlist control group will complete assessments at the same time points as the MIED group. After the 2-year follow-up, participants in the waitlist control group who wish to receive the program will be offered the same MIED course.
Ander: MIED
The intervention is delivered via the internet and is grounded in the psychopathological diamond model of emotional distress proposed by Liu and colleagues. The program is supported by a MIED knowledge base, the Mindfulness Study public account, supervision and question-answer records, and official materials from Liu Xinghua and the MIED team. These resources are integrated into a WeChat self-help mini-program and the MIED Mindfulness Assistant, an artificial intelligence-supported system developed using large language models such as Tencent Hunyuan and DeepSeek R1. Together, these tools support participants' learning and practice over a continuous 49-day training period.
Actieve vergelijker: WL
Participants in the waitlist control group will continue usual GERD treatment and health management during the 49-day observation period. They will not receive MIED, mindfulness training, or other structured psychological interventions during this period. Usual care may include medication, lifestyle advice, and necessary follow-up as determined by clinicians. The waitlist control group will complete assessments at the same time points as the MIED group. After the 2-year follow-up, participants in the waitlist control group who wish to receive the program will be offered the same MIED course.
Ander: TAU
Participants will continue usual GERD treatment and health management during the 49-day observation period. They will not receive MIED, mindfulness training, or other structured psychological interventions during this period. Usual care may include medication, lifestyle advice, and necessary follow-up as determined by clinicians. The waitlist control group will complete assessments at the same time points as the MIED group. After the 2-year follow-up, participants in the waitlist control group who wish to receive the program will be offered the same MIED course.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
GERD-HRQL
Tijdsspanne: 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), and 24 months (T7) post-intervention.
The GERD-HRQL is a self-report questionnaire used to assess the impact of gastroesophageal reflux symptoms on health-related quality of life. It evaluates symptom burden and the degree to which reflux symptoms affect daily functioning. Higher scores indicate poorer reflux-related quality of life.
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), and 24 months (T7) post-intervention.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Anxiety Severity and Impairment Scale (OASIS)
Tijdsspanne: 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), and 24 months (T7) post-intervention.
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).
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), and 24 months (T7) post-intervention.
Overall Depression Severity and Impairment Scale (ODSIS)
Tijdsspanne: 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), and 24 months (T7) post-intervention.
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).
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), and 24 months (T7) post-intervention.
Gastroesophageal Reflux Disease Questionnaire (GERD-Q)
Tijdsspanne: 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), and 24 months (T7) post-intervention.
The GERD-Q is a 6-item self-report questionnaire used to assess the frequency and severity of gastroesophageal reflux symptoms and to monitor treatment response. Total scores range from 0 to 18, with higher scores indicating more severe reflux-related symptoms.
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), and 24 months (T7) post-intervention.
Reflux Symptom Index (RSI)
Tijdsspanne: 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), and 24 months (T7) post-intervention.
The RSI is a 9-item self-report questionnaire used to assess symptoms related to laryngopharyngeal reflux, including chronic cough, hoarseness, throat clearing, and globus sensation. Total scores range from 0 to 45, with higher scores indicating more severe reflux-related throat symptoms.
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), and 24 months (T7) post-intervention.
Generalized Anxiety Disorder-7 (GAD-7)
Tijdsspanne: 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), and 24 months (T7) post-intervention.
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), and 24 months (T7) post-intervention.
Patient Health Questionnaire-9 (PHQ-9)
Tijdsspanne: 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), and 24 months (T7) post-intervention.
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), and 24 months (T7) post-intervention.
Treatment Inventory of Costs in Patients with Psychiatric Disorders (TIC-P)
Tijdsspanne: Baseline (T0); immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention.
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.
Baseline (T0); immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention.
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Tijdsspanne: 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), and 24 months (T7) post-intervention.
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).
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), and 24 months (T7) post-intervention.

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Short Form-8 Health Survey (SF-8)
Tijdsspanne: 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), and 24 months (T7) post-intervention.
The SF-8 is a brief self-report questionnaire used to assess general health-related quality of life. It measures physical and mental health domains and provides summary indicators of overall health status. Higher scores indicate better health-related quality of life.
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), and 24 months (T7) post-intervention.
Insomnia Severity Index (ISI)
Tijdsspanne: 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), and 24 months (T7) post-intervention.
The ISI is a 7-item self-report questionnaire used to assess the severity of insomnia symptoms and the degree of sleep-related impairment. Total scores range from 0 to 28, with higher scores indicating greater insomnia severity.
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), and 24 months (T7) post-intervention.
Connor-Davidson Resilience Scale (CD-RISC)
Tijdsspanne: 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), and 24 months (T7) post-intervention.
The CD-RISC is a self-report questionnaire used to assess psychological resilience and the ability to cope with stress and adversity. Higher scores indicate greater resilience.
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), and 24 months (T7) post-intervention.
Chinese Perceived Stress Scale (CPSS)
Tijdsspanne: 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), and 24 months (T7) post-intervention.
The Chinese Perceived Stress Scale (CPSS) will be used to assess participants' subjective perception of life stress. This scale is derived from the Perceived Stress Scale developed by Cohen et al., and primarily assesses the extent to which individuals perceive life events over the past month as unpredictable, uncontrollable, and overwhelming (Cohen et al., 1983). The Chinese version of the CPSS has been applied and validated in Chinese populations, with studies demonstrating good internal consistency, structural validity, and criterion-related validity, supporting its use for assessing subjective stress levels (Leung et al., 2010; Ng, 2013).
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), and 24 months (T7) post-intervention.
Satisfaction With Life Scale (SWLS)
Tijdsspanne: 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), and 24 months (T7) post-intervention.
The SWLS is a self-report questionnaire used to assess global cognitive judgments of life satisfaction. Higher scores indicate greater life satisfaction.
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), and 24 months (T7) post-intervention.
Adverse Events
Tijdsspanne: 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), and 24 months (T7) post-intervention.
To evaluate the safety of the intervention, this study will record adverse events (AEs) and serious adverse events (SAEs) occurring during the study period. These events will be defined, documented, and reported in accordance with international clinical trial guidelines, and will be descriptively analyzed with respect to the time of occurrence, severity, relationship to the intervention, and outcome
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), and 24 months (T7) post-intervention.
the Engaging in Life Scale
Tijdsspanne: Baseline (T0); immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention.
The Engaging in Life Scale will be used to assess the degree to which individuals engage in key life domains such as work, study, social interaction, and sleep, and is an important tool for evaluating levels of engagement in life (Chen et al., 2026).
Baseline (T0); immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention.
the Distress Tolerance Scale (DTS)
Tijdsspanne: Baseline (T0); immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention.
Distress tolerance will be assessed using the Distress Tolerance Scale (DTS), which measures individuals' capacity to tolerate negative emotional experiences and their regulatory responses to emotional distress (Simons & Gaher, 2005).
Baseline (T0); immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention.
the Discomfort Intolerance Scale (DIS)
Tijdsspanne: Baseline (T0); immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention.
The Discomfort Intolerance Scale (DIS) will be used to assess tolerance of unpleasant bodily sensations, which has been widely applied in anxiety disorder and emotion regulation research (Schmidt et al., 2006).
Baseline (T0); immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention.
the Excessive Emotional Behavior Scale (EEBS)
Tijdsspanne: Baseline (T0); immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention.
The Excessive Emotional Behavior Scale (EEBS) will be used to assess excessive emotion-driven and avoidant behaviors under negative affective states, thereby providing a more comprehensive assessment of this psychological process (Zhang et al., 2026).
Baseline (T0); immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention.
the Brief Experiential Avoidance Questionnaire (BEAQ)
Tijdsspanne: Baseline (T0); immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention.
The Brief Experiential Avoidance Questionnaire (BEAQ) will be used to further assess experiential avoidance as a core process (Gámez et al., 2014).
Baseline (T0); immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention.
the Cognitive Flexibility Inventory (CFI)
Tijdsspanne: Baseline (T0); immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention.
Cognitive flexibility will be measured using the Cognitive Flexibility Inventory (CFI), which assesses individuals' ability to shift cognitive frameworks, generate alternative explanations, and adopt adaptive thinking strategies under stress (Dennis & Vander Wal, 2010).
Baseline (T0); immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Xinghua Liu

Onderzoekers

  • Hoofdonderzoeker: Xinghua Liu, Dr., Peking University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

29 juni 2026

Primaire voltooiing (Geschat)

15 mei 2028

Studie voltooiing (Geschat)

15 mei 2028

Studieregistratiedata

Eerst ingediend

16 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

19 juni 2026

Eerst geplaatst (Werkelijk)

25 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 september 2026

Laatste update ingediend die voldeed aan QC-criteria

5 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • E20260611

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Deidentified individual participant data (IPD) underlying the results reported in the main publication will be available upon reasonable request after publication of the primary trial results. The shared data will include deidentified participant-level data used in the primary and secondary analyses, including baseline characteristics, group allocation, outcome measures, follow-up assessments, adherence indicators, and safety outcomes. Directly or indirectly identifiable information will not be shared. Access will be provided to qualified researchers with a methodologically sound proposal, subject to approval by the principal investigator and relevant ethics requirements, and after completion of a data use agreement.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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