- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07715916
Exploring the Feasibility and Effectiveness of a MIED-Based Adolescent Mindfulness Intervention Group for Youth With Emotional Distress
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mei Yuan, M.S. in Psychology
- Phone Number: +8618513356664
- Email: bettyyuan8@163.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
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 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Generalized Anxiety Disorder 7-item scale(GAD-7)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
10-item Connor-Davidson Resilience Scale(CD-RISC-10)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Process indicator - attendance rate
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xinghua Liu, PhD, Peking University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- E20260701
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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