A Preliminary Study on the Feasibility and Effects of a Mindfulness Intervention for Emotional Distress (MIED)-Based Group Intervention for Adolescents (Online Format)
Background: Emotional distress (anxiety and depressive symptoms) among adolescents is rising globally. In China, the detection rate of depression risk among secondary school students is 24.6%, and that of anxiety risk is 18.1%; comorbidity, relapse and disability rates are all high, seriously affecting adolescents' academic performance, social relationships and quality of life. Mindfulness-based interventions (MBIs) have shown substantial effects in children and adolescents, with meta-analyses reporting a moderate effect size for internalizing problems (Hedges' g = 0.47). Group-based mindfulness interventions for adolescents are feasible: the group format improves efficiency, reduces costs and provides social support. However, existing research remains limited in cultural adaptation and in the systematicity of intervention protocols. The MIED (Mindfulness Intervention for Emotional Distress) system, developed by Professor Liu Xinghua on the basis of MBSR and the Unified Protocol (UP), centres on the "diamond model" of emotional distress, which identifies four core maintaining mechanisms: engagement in life, tolerance of distress, emotional behaviours, and cognitive flexibility. Adult studies of MIED show significant improvement in emotional distress, yet no dedicated study has applied it to adolescents.
Methods: This is an exploratory feasibility study using a single-group pre-post design. It plans to recruit 26 adolescents aged 12-18 years with emotional distress for an 8-week online MIED group intervention for adolescents (two online groups, 12-13 participants per group, with an expected effective sample of 20-24). Data will be collected at multiple time points: baseline, after the 4th session, after the 8th session, and at 1-month follow-up.
Objectives: The primary objective is to evaluate the feasibility of the MIED-based adolescent mindfulness group intervention (recruitment feasibility, retention feasibility, implementation feasibility, acceptability, and safety). The secondary objective is to preliminarily evaluate the intervention's effects on anxiety, depression, stress and other outcomes, and to estimate effect sizes, thereby providing methodological preparation for a subsequent large-scale randomized controlled trial (RCT).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mei Yuan
- Numéro de téléphone: +8618513356664
- E-mail: bettyyuan8@163.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 severe 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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Adolescent Group(online)
Adolescent Group Curriculum：8-week online group curriculum adapted from the adult MIED course for adolescents' cognitive development, social needs and preferences. 8 weekly sessions, 90-120 min each, via video conferencing; 2-3 groups of 9-13 participants (27-30 recruited, expected effective sample 20-24). Based on the MIED diamond model: engagement in life, tolerance of distress, emotional behaviours, cognitive flexibility. Interactive design and AI-assisted tools boost participation and practice adherence; modules refined per prior evidence. Parent Group Curriculum：Based on the parent group approach in the Chinese UP-A (Pan et al., 2025). Aims: improve parents' understanding of adolescent emotional distress; teach strategies supporting adolescents' mindfulness practice and emotion regulation; improve parent-child communication; support parents' own MIED practice and stress management. 4 sessions, every 2 weeks, 120 min each, online, parallel with the adolescent group. |
Adolescent Group： Basic curriculum structure: 8 sessions, once per week, 90-120 minutes per session, 12-20 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Generalized Anxiety Disorder 7-item scale(GAD-7)
Délai: 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)
Délai: 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)
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
10-item Connor-Davidson Resilience Scale(CD-RISC-10)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Process indicator - attendance rate
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Xinghua Liu, Peking University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
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Dates d'inscription aux études
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Première soumission répondant aux critères de contrôle qualité
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Mises à jour des dossiers d'étude
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Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- E20261018
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