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

NCT07715916 | Not Yet Recruiting

• 1 other identifier: E20260701
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Emotional Distress

Keywords

Emotional Distress; Adolescent; Mindfulness Intervention Group; Feasibility; Effectiveness; MIED-based

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  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)

  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)

Secondary Outcomes (5)

• 10-item Connor-Davidson Resilience Scale(CD-RISC-10)

  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)

  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)

  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)

  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)

  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)

Other Outcomes (5)

• Process indicator - attendance rate

  Week 8 (immediately after session 8,T3)

• Process indicator -homework completion rate

  Week 8 (immediately after session 8,T3)

• Process indicator - dropout rate and reasons

  Week 8 (immediately after session 8,T3)

Study Arms (1)

Adolescent Group

EXPERIMENTAL

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.

Other: MIED-based Adolescent Mindfulness Intervention Group

Interventions

MIED-based Adolescent Mindfulness Intervention Group OTHER

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.

Adolescent Group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Xinghua Liu: lead

Study Officials

• Xinghua Liu, PhD

  Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei Yuan, M.S. in Psychology

CONTACT

+8618513356664; bettyyuan8@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Reasearcher

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 21, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE