Mindfulness-based programs for suicidal thoughts and self-harm in Korean youth
Development and Biological Efficacy Validation of Youth Suicide and Self-Harm Intervention Program
We will test whether two mindfulness-based programs for Korean adolescents and young adults reduce suicidal thoughts, self-harm, depression, and problems with sleep and emotion regulation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 15 Years to 30 Years |
| Sex | All |
| Sponsor | Ajou University School of Medicine Academic / other |
| Locations | 1 site (Suwon, Gyeonggi-do) |
| Trial ID | NCT07395752 on ClinicalTrials.gov |
What this trial studies
This project develops two age-tailored, mindfulness-informed intervention programs—one for middle/high school students and one for young adults—and compares them to general mental health education using a randomized or quasi-experimental design. Clinical outcomes include suicidal ideation, self-injurious behavior, depressive symptoms, hopelessness, sleep, and emotion-regulation measures collected before and after the interventions. Biological measures include resting-state fMRI metrics (ALFF, ReHo, functional connectivity) and monitoring of social rhythm patterns to explore neurobiological and behavioral correlates of clinical change. The study also creates structured therapist and participant manuals and the first Korean clinical practice guidelines for adolescent and young adult suicide/self-harm care.
Who should consider this trial
Good fit: Korean adolescents and young adults aged 15–30 who have had a recent non‑suicidal self‑injury incident or a suicide attempt in the past six months and meet the specified screening scores are the primary candidates.
Not a fit: Individuals with schizophrenia, bipolar disorder, developmental disorders (including intellectual disability or autism spectrum disorder), acute psychosis, severe physical illness that prevents participation, or contraindications to MRI (e.g., metallic implants) are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, these programs could reduce suicidal ideation and self-harm in Korean youth and provide structured manuals and national guidelines to improve care and training.
How similar studies have performed: Mindfulness-informed interventions have shown promise for reducing self-harm and suicidal ideation in prior work, but combining these clinical programs with resting-state fMRI and social rhythm biomarkers in Korean youth is largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. General Criteria * Aged between 15 and 30 years * Obtained informed consent from a parent or legal guardian for participants under 19 years of age 2. For the Self-Harm Group * At least one incident of non-suicidal self-injury (NSSI) within the last 6 months * Self-Harm Screening Inventory (SHSI) score of at least 1 (at least one "Yes" response) 3. For the Suicide Attempt Group * Suicide attempt within the last 6 months * Depressive Symptom Inventory-Suicidality Subscale (DSI-SS) score of 3 or higher Exclusion Criteria: 1. Psychiatric and Developmental Conditions * History of developmental disorders, including intellectual disability or autism spectrum disorder * Diagnosis of schizophrenia or bipolar disorder * Currently in an acute psychotic state 2. Medical and Physical Conditions * Presence of severe physical illness that interferes with daily life * Presence of metallic substances in the body (e.g., cardiac pacemakers, artificial heart valves) that are incompatible with fMRI * Diagnosis of claustrophobia * Current Treatment and Intervention * Currently receiving regular and active cognitive behavioral therapy (CBT) * Initiation of pharmacological treatment within the last 2 months 3. Communication and Consent * Inability to communicate fluently in Korean * Failure to obtain informed consent from a parent or legal guardian for participants under 19 years of age
Where this trial is running
Suwon, Gyeonggi-do
- Ajou University Medical Center — Suwon, Gyeonggi-do, South Korea (Recruiting)
Study contacts
- Study coordinator: Yunmi Shin, MD
- Email: ymshin@ajou.ac.kr
- Phone: +82-31-219-5180
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.