Temporal interference stimulation for non‑suicidal self‑injury in adolescent depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, inpatient study will enroll 60 participants with major depressive disorder and recent non‑suicidal self‑injury to receive either active or sham temporal interference stimulation targeted to the right subgenual anterior cingulate cortex. Treatments are delivered twice daily for 30 minutes over 5–7 days, with clinical ratings collected at baseline, immediately after treatment, and at 2, 4, and 8 weeks follow‑up. Primary and secondary outcomes include NSSI frequency and severity, depressive and anxiety symptom scales (HAMD‑17, HAMA), and measures of suicidal ideation, sleep, somatic symptoms, rumination, impulsivity, and aggression. Safety and tolerability will also be recorded throughout the study period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Meet the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders 5th Edition) diagnostic criteria for major depressive disorder.
2. Patients aged 12-22 years with at least one guardian to monitor them for 3 months
3. HAMD-17 Total score ≥18
4. Patients who had two or more non-suicidal self-injury behaviors meeting the 5.DSM-5 diagnostic criteria in the 2 weeks before admission (NSSI behavior of more than 5 days in the past year)

6.Obtain informed consent from patients and guardians

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Exclusion Criteria:

1. Substance abusers such as psychoactive drugs or alcohol.
2. Severe physical disability and unable to complete follow-up.
3. Comorbid other major mental illnesses that meet the DSM-5 criteria, such as bipolar disorder, schizophrenia, mental retardation, dementia, severe cognitive impairment, attention deficit hyperactivity disorder, etc.
4. Suffering from any severe physical disease, neurological disease, traumatic brain injury, etc, that affects the structure or function of the brain in the lifetime.

   Unable to read, understand and complete the assessment or to cooperate with the investigators.
5. Any implants covering a pacemaker, metallic or magnetic objects in the body, or other conditions not suitable for TIS.
6. Those who have received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) or TMS within 3 months before baseline.
7. Other examination abnormalities considered to be inappropriate by investigators.

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Where it's running

• The Second Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting

Study contacts

• Study coordinator: Yanghua Tian, PhD
• Email: tianyh@ahmu.edu.cn
• Phone: +86-13955188448

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.