ClinicalTrials.gg
Not yet recruitingNCT07930754Updated Nov 12, 2026

A Preliminary Study on the Feasibility and Effects of a Mindfulness Intervention for Emotional Distress (MIED)-Based Group Intervention for Adolescents (Online Format)

An interventional study of MIED-based Adolescent Mindfulness Intervention Group in Emotional Distress, sponsored by Xinghua Liu. Not yet recruiting. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Xinghua Liu · Not applicable, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
12 Years to 18 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Emotional Distress

Keywords

  • Emotional Distress
  • Adolescent
  • Mindfulness Intervetion Group
  • Feasibility
  • Effectiveness
  • MIED-based
  • online
03

In context

Lead sponsor

Xinghua Liu is the lead sponsor of 7 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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).

from both the participant and their parent/legal guardian

Exclusion criteria

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)

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    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.

    Other: MIED-based Adolescent Mindfulness Intervention Group

Interventions

  • OtherMIED-based Adolescent Mindfulness Intervention 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.

06

What researchers measure

Primary outcomes

  1. 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)

    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)

  2. 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.

    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)

  3. 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.

    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)

Secondary outcomes

  1. 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

    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)

  2. 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

    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)

  3. 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).

    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)

  4. 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).

    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)

  5. 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

    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)

Other outcomes

  1. Process indicator - attendance rate

    attendance rate. Scores range from 0% to 100%, with higher scores indicating better outcome.

    Time frame: Week 8 (immediately after session 8,T3)

  2. Process indicator -homework completion rate

    Scores range from 0% to 100%, with higher scores indicating better outcome

    Time frame: Week 8 (immediately after session 8,T3)

  3. Process indicator - dropout rate and reasons

    dropout rate and reasons: Scores range from 0% to 100%, with higher scores indicating worse outcome

    Time frame: Week 8 (immediately after session 8,T3)

  4. Acceptability

    self-developed acceptability and satisfaction scale (adolescent/parent version, 1-5 Likert scale).with higher scores indicating better outcome

    Time frame: Week 8 (immediately after session 8,T3)

  5. Adverse Event Records

    adverse event records (emotional deterioration, self-harm reports, number of crisis triggers);with more records indicating worse outcome

    Time frame: Baseline (T1); Week4 (T2) during the intervention; immediately post-intervention at Week 8(T3); and1 month(post-intervention follow-up,T4)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Mar 2027, 4 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 4, 2026
First posted
Nov 12, 2026
StartEst.
Nov 6, 2026
Primary completionEst.
Mar 31, 2027
CompletionEst.
Mar 31, 2027
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07930754
Lead sponsor
Xinghua Liu
Responsible party
Xinghua Liu (Reasearcher, Peking University) — Sponsor-investigator
First posted
Nov 12, 2026
Start date
Nov 6, 2026 (estimated)
Primary completion
Mar 31, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Nov 12, 2026

Study contacts

Mei Yuan
Contact
bettyyuan8@163.com
+8618513356664
Xinghua Liu
principal investigator · Peking University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion