TIS for NSSI in Adolescent Depression (NCT07554755) | Clinical Trial Compass
RecruitingNot Applicable
TIS for NSSI in Adolescent Depression
China60 participantsStarted 2026-04-30
Plain-language summary
Temporal Interference Stimulation (TIS) has been successfully used to help patients with depression. However, its role in alleviating self injuries remained uncertain. This trial will compare the effectiveness of TIS to a placebo control on non-suicidal self injury (NSSI) in patients with major depressive disorder(MDD).
Who can participate
Age range12 Years – 22 Years
SexALL
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Inclusion criteria
✓. Meet the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders 5th Edition) diagnostic criteria for major depressive disorder.
✓. Patients aged 12-22 years with at least one guardian to monitor them for 3 months
✓. HAMD-17 Total score ≥18
✓. 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)
✓.Obtain informed consent from patients and guardians
Exclusion criteria
✕. Substance abusers such as psychoactive drugs or alcohol.
✕. Severe physical disability and unable to complete follow-up.
✕. 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.
✕. Suffering from any severe physical disease, neurological disease, traumatic brain injury, etc, that affects the structure or function of the brain in the lifetime.
✕. Any implants covering a pacemaker, metallic or magnetic objects in the body, or other conditions not suitable for TIS.
✕. Those who have received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) or TMS within 3 months before baseline.
What they're measuring
1
Changes in the Adolescent Non-Suicidal Self-Injurious Behavior Assessment Questionnaire (ANSAQ)
Timeframe: Baseline, the day after the end of TIS, 2 weeks after the end of TIS, 4 weeks after the end of TIS, 8 weeks after the end of TIS
2
Changes in the 17-item Hamilton Rating Scale for Depression (HAMD-17)
Timeframe: Baseline, the day after the end of TIS, 2 weeks after the end of TIS, 4 weeks after the end of TIS, 8 weeks after the end of TIS
Trial details
NCT IDNCT07554755
SponsorThe Second Hospital of Anhui Medical University