Emotional DistressNCT07715916
Exploring the Feasibility and Effectiveness of a MIED-Based Adolescent Mindfulness Intervention Group for Youth With Emotional Distress
A study testing MIED-based Adolescent Mindfulness Intervention Group in people with Emotional Distress, run by Xinghua Liu.
Trial 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%. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Emotional Distress
- What is being tested?
- MIED-based Adolescent Mindfulness Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- MIED-based Adolescent Mindfulness Intervention Group
- Keywords
- Emotional Distress, Adolescent, Mindfulness Intervention Group, Feasibility, Effectiveness, MIED-based
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIED-based Adolescent Mindfulness Intervention GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: MIED-based Adolescent Mindfulness Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 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)
Resilience :Connor-Davidson Resilience Scale-10, 10 items, self-report;Scores range from 0 to 40, with higher scores indicating better outcome
Measured: 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)
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
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinghua Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xinghua Liu, Peking University
- Investigators
- Xinghua Liu, PhD, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715916
- Sponsor's protocol ID
- E20260701
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (IPD) underlying the results reported in the main publication will be available upon reasonable request after publication of the primary trial results. The shared data will include deidentified participant-level data used in the primary and secondary analyses, including baseline characteristics, group allocation, outcome measures, follow-up assessments, adherence indicators, and safety outcomes. Directly or indirectly identifiable information will not be shared. Access will be provided to qualified researchers with a methodologically sound proposal, subject to approval by the principal investigator and relevant ethics requirements, and after completion of a data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Feasibility and Effectiveness of a MIED-Based Adolescent Mindfulness Intervention Group for Youth With Emotional Distress
- ClinicalTrials.gov ID
- NCT07715916
- Acronym / sponsor ID
- E20260701
- Conditions
- Emotional Distress
- Keywords
- Emotional Distress, Adolescent, Mindfulness Intervention Group, Feasibility, Effectiveness, MIED-based
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xinghua LiuUniversity, hospital or other
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescent Group | Experimental | Other: MIED-based Adolescent Mindfulness Intervention GroupAdolescent 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIED-based Adolescent Mindfulness Intervention GroupAdolescent 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. | Other | Adolescent Group |
Primary outcome
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)
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.
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.
5 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data (IPD) underlying the results reported in the main publication will be available upon reasonable request after publication of the primary trial results. The shared data will include deidentified participant-level data used in the primary and secondary analyses, including baseline characteristics, group allocation, outcome measures, follow-up assessments, adherence indicators, and safety outcomes. Directly or indirectly identifiable information will not be shared. Access will be provided to qualified researchers with a methodologically sound proposal, subject to approval by the principal investigator and relevant ethics requirements, and after completion of a data use agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xinghua Liu, PhD principal investigator
Peking University
Questions about this trial
What is this clinical trial studying?
A study testing MIED-based Adolescent Mindfulness Intervention Group in people with Emotional Distress, run by Xinghua Liu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mei Yuan, M.S. in Psychology (+8618513356664, bettyyuan8@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.