About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
MIED-based Adolescent Mindfulness Intervention Group
Other interventionAdolescent 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.
Treatment groups
Trial outcomes
Primary outcomes
Generalized Anxiety Disorder 7-item scale(GAD-7)
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)
Patient Health Questionnaire-9(PHQ-9)
Depressive symptoms:Patient Health Questionnaire-9, 9 items, self-report;Scores range from 0 to 27, with higher scores indicating worse outcome.
Perceived Stress Scale(PSS-10)
Perceived stress:Perceived Stress Scale, 10 items, self-report;Scores range from 0 to 40, with higher scores indicating worse outcome.
Secondary outcomes
10-item Connor-Davidson Resilience Scale(CD-RISC-10)
Resilience :Connor-Davidson Resilience Scale-10, 10 items, self-report;Scores range from 0 to 40, with higher scores indicating better outcome
Difficulties in Emotion Regulation Scale-Short Form(DERS-16)
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
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).
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).
Other outcomes
Process indicator - attendance rate
attendance rate. Scores range from 0% to 100%, with higher scores indicating better outcome.
Process indicator -homework completion rate
Scores range from 0% to 100%, with higher scores indicating better outcome.
Process indicator - dropout rate and reasons
dropout rate and reasons: Scores range from 0% to 100%, with higher scores indicating worse outcome
Acceptability
self-developed acceptability and satisfaction scale (adolescent/parent version, 1-5 Likert scale).with higher scores indicating better outcome
Locations
Sponsors and contacts
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Xinghua Liu
Lead sponsor
Peking University
Sponsor institution
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