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Exploring the Feasibility and Effectiveness of a MIED-Based Adolescent Mindfulness Intervention Group for Youth With Emotional Distress

20. července 2026 aktualizováno: Xinghua Liu

Background: Adolescent emotional distress (anxiety and depressive symptoms) is rising globally. The detection rate of depression risk among Chinese middle and high school students reaches 24.6%, with anxiety risk at 18.1%. These conditions show high comorbidity, high recurrence, and high disability rates, seriously affecting adolescents' academic performance, social relationships, and quality of life. Mindfulness-Based Interventions (MBIs) have shown significant effects in children and adolescent populations; meta-analyses indicate a moderate effect size on adolescent internalizing problems (Hedges' g = 0.47). Group-based adolescent mindfulness interventions are feasible, as the group format improves efficiency, reduces costs, and provides social support. However, existing research still has limitations in cultural adaptation and systematic intervention design. The MIED (Mindfulness Intervention for Emotional Distress) systematic theory was developed by researcher Liu Xinghua based on MBSR/UP. Its core theory is the "Diamond Model" of emotional distress, identifying four core maintenance mechanisms: engagement in life, distress tolerance regulation, emotional behavior regulation, and cognitive flexibility enhancement. Adult studies on MIED have shown significant improvements in emotional distress symptoms, but no specialized research has been conducted in adolescent populations.

Methods: This study is a feasibility exploratory study employing a single-group pre-post design, planning to recruit 24-30 adolescents aged 12-18 years with emotional distress, to undergo an 8-week MIED adolescent mindfulness intervention group. Data will be collected at multiple time points: baseline, after session 4, after session 8, and at 1-month follow-up.

Objectives: The primary objective is to evaluate the feasibility of the MIED-based adolescent mindfulness intervention group (recruitment feasibility, retention feasibility, implementation feasibility, acceptability, and safety). The secondary objective is to preliminarily assess the intervention's effectiveness on outcomes such as anxiety, depression, and stress, estimate effect sizes, and provide methodological preparation for subsequent large-scale randomized controlled trials (RCTs).

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

40

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Mei Yuan, M.S. in Psychology
  • Telefonní číslo: +8618513356664
  • E-mail: bettyyuan8@163.com

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Age 12-18 years, minors (junior and senior high school level; special note: individuals who exceed the age criterion due to dropout or leave of absence but are still in junior or senior high school may be included if they meet all other inclusion criteria).
  • PHQ-9 total score 10-19 or GAD-7 total score 10-14 (either criterion is sufficient, indicating mild to moderate depressive or anxiety symptoms).
  • Informed consent from both the participant and their parent/legal guardian.

Exclusion Criteria:

  • PHQ-9 total score ≥20 or GAD-7 total score ≥15, or clinical diagnosis of anxiety or depressive disorder (if severe depression or anxiety, referral to individual therapy is recommended).
  • PHQ-9 item 9 score ≥2 and clinical interview confirming active suicidal ideation or plan.
  • Presence of psychotic symptoms, bipolar disorder, or severe self-harm behaviors (requiring medical treatment).
  • Currently receiving other systematic psychotherapy.
  • Severe cognitive or developmental disorders that prevent understanding of group content.
  • Unable to use a smartphone (affecting use of AI-assisted tools).

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Adolescent Group

Adolescent Group Curriculum： An 8-week adolescent group curriculum adapted from the MIED adult 8-week program, incorporating the cognitive developmental characteristics, social needs, and preferences of adolescents. Curriculum content is based on the MIED Diamond Model modules: awareness and mindfulness, emotion recognition, engagement in life, distress tolerance regulation, emotional behavior regulation, cognitive flexibility enhancement, integration and daily practice, etc.

Parent Group Curriculum： The parent group setup references the approach of Pan et al. (2025) in including a parent group in the Chinese version of UP-A. Core objectives of the parent group include: enhancing parents' understanding of adolescent emotional distress; teaching parents strategies to support adolescent mindfulness practice and emotion regulation; improving parent-child communication; and improving parents' own MIED Diamond Model practice and stress management.
Jiný: MIED-based Adolescent Mindfulness Intervention Group

Adolescent Group： Basic curriculum structure: 8 sessions, once per week, 90-120 minutes per session, 12-15 participants per group.

Parent Group Curriculum： Number of sessions: 4 (or 8, synchronized with the adolescent group), once every 2 weeks (or once per week), 120 minutes per session.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Generalized Anxiety Disorder 7-item scale(GAD-7)
Časové okno: Screening phase(Pre-enrollment screening,T0）, Baseline assessment(1 day before session 1,T1), Week4(After session 4,T2) ,Week8(After session 8,T3), and 1 month(post-intervention follow-up,T4)
Anxiety symptoms: Generalized Anxiety Disorder 7-item scale (GAD-7). Scores range from 0 to 21, with higher scores indicating worse outcome (more severe anxiety symptoms)
Screening phase(Pre-enrollment screening,T0）, Baseline assessment(1 day before session 1,T1), Week4(After session 4,T2) ,Week8(After session 8,T3), and 1 month(post-intervention follow-up,T4)
Patient Health Questionnaire-9(PHQ-9)
Časové okno: Screening phase(Pre-enrollment screening,T0）, Baseline assessment(1 day before session 1,T1), Week4(After session 4,T2) ,Week8(After session 8,T3), and 1 month(post-intervention follow-up,T4)
Depressive symptoms:Patient Health Questionnaire-9, 9 items, self-report;Scores range from 0 to 27, with higher scores indicating worse outcome.
Screening phase(Pre-enrollment screening,T0）, Baseline assessment(1 day before session 1,T1), Week4(After session 4,T2) ,Week8(After session 8,T3), and 1 month(post-intervention follow-up,T4)
Perceived Stress Scale(PSS-10)
Časové okno: Screening phase(Pre-enrollment screening,T0）, Baseline assessment(1 day before session 1,T1), Week4(After session 4,T2) ,Week8(After session 8,T3), and 1 month(post-intervention follow-up,T4)
Perceived stress:Perceived Stress Scale, 10 items, self-report;Scores range from 0 to 40, with higher scores indicating worse outcome.
Screening phase(Pre-enrollment screening,T0）, Baseline assessment(1 day before session 1,T1), Week4(After session 4,T2) ,Week8(After session 8,T3), and 1 month(post-intervention follow-up,T4)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
10-item Connor-Davidson Resilience Scale(CD-RISC-10)
Časové okno: Baseline assessment(1 day before session 1,T1), Week4(After session 4,T2) ,Week8(After session 8,T3), and 1 month(post-intervention follow-up,T4)
Resilience :Connor-Davidson Resilience Scale-10, 10 items, self-report;Scores range from 0 to 40, with higher scores indicating better outcome
Baseline assessment(1 day before session 1,T1), Week4(After session 4,T2) ,Week8(After session 8,T3), and 1 month(post-intervention follow-up,T4)
Difficulties in Emotion Regulation Scale-Short Form(DERS-16)
Časové okno: Baseline assessment(1 day before session 1,T1), Week4(After session 4,T2) ,Week8(After session 8,T3), and 1 month(post-intervention follow-up,T4)
Difficulties in emotion regulation:Difficulties in Emotion Regulation Scale-Brief, 16 items, self-report;Scores range from 16 to 80, with higher scores indicating worse outcome
Baseline assessment(1 day before session 1,T1), Week4(After session 4,T2) ,Week8(After session 8,T3), and 1 month(post-intervention follow-up,T4)
Overall Anxiety Severity and Impairment Scale (OASIS)
Časové okno: Baseline (T1), Weeks 1, 2, 3, 4 (T2), 5, 6, 7 (during intervention), Week 8 immediately post-intervention (T3), and 1 month(post-intervention follow-up,T4)
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 (T1), Weeks 1, 2, 3, 4 (T2), 5, 6, 7 (during intervention), Week 8 immediately post-intervention (T3), and 1 month(post-intervention follow-up,T4)
Overall Depression Severity and Impairment Scale (ODSIS)
Časové okno: Baseline (T1), Weeks 1, 2, 3, 4 (T2), 5, 6, 7 (during intervention), Week 8 immediately post-intervention (T3), and 1 month(post-intervention follow-up,T4)
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 (T1), Weeks 1, 2, 3, 4 (T2), 5, 6, 7 (during intervention), Week 8 immediately post-intervention (T3), and 1 month(post-intervention follow-up,T4)
Five Facet Mindfulness Questionnaire-Short Form(FFMQ-SF)
Časové okno: Baseline assessment(1 day before session 1,T1), Week4(After session 4,T2) ,Week8(After session 8,T3), and 1 month(post-intervention follow-up,T4)
Mindfulness level:Five Facet Mindfulness Questionnaire-Short Form, 20 items, self-report; Scores range from 0 to 5 for average item scores and 24-120 for total scores, with higher scores indicating better outcome
Baseline assessment(1 day before session 1,T1), Week4(After session 4,T2) ,Week8(After session 8,T3), and 1 month(post-intervention follow-up,T4)

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Process indicator - attendance rate
Časové okno: Week 8 (immediately after session 8,T3)
attendance rate. Scores range from 0% to 100%, with higher scores indicating better outcome.
Week 8 (immediately after session 8,T3)
Process indicator -homework completion rate
Časové okno: Week 8 (immediately after session 8,T3)
Scores range from 0% to 100%, with higher scores indicating better outcome.
Week 8 (immediately after session 8,T3)
Process indicator - dropout rate and reasons
Časové okno: Week 8 (immediately after session 8,T3)
dropout rate and reasons: Scores range from 0% to 100%, with higher scores indicating worse outcome
Week 8 (immediately after session 8,T3)
Acceptability
Časové okno: Week 8 (immediately after session 8,T3)
self-developed acceptability and satisfaction scale (adolescent/parent version, 1-5 Likert scale).with higher scores indicating better outcome
Week 8 (immediately after session 8,T3)
Adverse Event Records
Časové okno: Baseline (T1); Week4 (T2) during the intervention; immediately post-intervention at Week 8(T3); and1 month(post-intervention follow-up,T4)
adverse event records (emotional deterioration, self-harm reports, number of crisis triggers);with more records indicating worse outcome
Baseline (T1); Week4 (T2) during the intervention; immediately post-intervention at Week 8(T3); and1 month(post-intervention follow-up,T4)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Xinghua Liu

Vyšetřovatelé

  • Vrchní vyšetřovatel: Xinghua Liu, PhD, Peking University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

20. července 2026

Primární dokončení (Odhadovaný)

31. března 2027

Dokončení studie (Odhadovaný)

31. května 2027

Termíny zápisu do studia

První předloženo

1. července 2026

První předloženo, které splnilo kritéria kontroly kvality

20. července 2026

První zveřejněno (Aktuální)

21. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

20. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • E20260701

Plán pro data jednotlivých účastníků (IPD)

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ANO

Popis plánu IPD

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.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • ANALYTIC_CODE
  • CSR

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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