TIS for NSSI in Adolescent Depression
Recruiting · NCT07554755 · Interventional (participants receive a specific treatment) · Lead sponsor: The Second Hospital of Anhui Medical University
View the official record on ClinicalTrials.gov →Interventions studied
Active Temporal Interference Stimulation (TIS)Sham Temporal Interference Stimulation (TIS)
What this trial is about
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 take part
Age range
12 Years to 22 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
- btain 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.
- Unable to read, understand and complete the assessment or to cooperate with the investigators.
- 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.
- Other examination abnormalities considered to be inappropriate by investigators.
Where it is running
1 location listed.
- The Second Affiliated Hospital of Anhui Medical University - Hefei, Anhui, China