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

Обзор

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).

Вмешательства

• Другое 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.

Первичные конечные точки

• Generalized Anxiety Disorder 7-item scale(GAD-7) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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)]

Вторичные конечные точки (5)

• 10-item Connor-Davidson Resilience Scale(CD-RISC-10) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07715916 · E20260701

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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