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NCT Number: 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).

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Key information

Conditions

Emotional Distress

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. 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)

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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).

  4. 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).

  5. 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

Other outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mei Yuan, M.S. in Psychology

CONTACT

[email protected]

+8618513356664

Sponsors and collaborators

Lead sponsor

Xinghua Liu

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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