TIS for NSSI in Adolescent Depression

NCT07554755 | Recruiting DMC

• 1 other identifier: AHMU-TIS-NSSI
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Major Depressive Disorder; Non Suicidal Self Injury; Temporal Interference Stimulation

Outcome Measures

Primary Outcomes (2)

• Changes in the Adolescent Non-Suicidal Self-Injurious Behavior Assessment Questionnaire (ANSAQ)

  Containing one subscale evaluating the frequency and primary methods of self-injury behaviors in patients over the past 2 weeks,and one subscale ranging from 0 to 10 to assess the self-injurious thoughts, with 0 indicating "not at all" and 10 indicating "very strongly."

  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

• Changes in the 17-item Hamilton Rating Scale for Depression (HAMD-17)

  Range from 0-52, higher score indicates more severe symptoms

  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

Secondary Outcomes (11)

• Changes in Hamilton Anxiety Scale (HAMA)

  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

• Change in the Patient Health Questionnaire-15 (PHQ-15)

  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

• Changes in Insomnia Severity Index (ISI)

  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

• Changes in Ruminative Responses Scale (RRS)

  Baseline, the day after the end of TIS

• Changes in Beck Suicidal Scale Inventory (BSI)

  Baseline, the day after the end of TIS

Other Outcomes (2)

• Changes in the Pittsburgh Sleep Quality Index (PSQI)

  Baseline

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  The day after the end of TIS

Study Arms (2)

real stimulation

ACTIVE COMPARATOR

Participants will receive active TIS 10 to 14 times.

Device: Active Temporal Interference Stimulation (TIS)

sham stimulation

SHAM COMPARATOR

Participants will receive sham TIS 10 to 14 times.

Device: Sham Temporal Interference Stimulation (TIS)

Interventions

Active Temporal Interference Stimulation (TIS) DEVICE

Active stimulation to the right subgenual anterior cingulate cortex; 2 sessions per day, 30 minutes per session, including a 30-second current ramp-up at the beginning and a 30-second ramp-down at the end, for 5-7 days.

real stimulation

Sham Temporal Interference Stimulation (TIS) DEVICE

Sham stimulation had only 30 seconds of current ramping-up and ramping-down at the beginning and end of the stimulation, respectively, to simulate the sensation of actual stimulation.

sham stimulation

Eligibility Criteria

• Age: 12 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Anhui Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

RECRUITING

MeSH Terms

Conditions

Self-Injurious Behavior; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Yanghua Tian, PhD

CONTACT

+86-13955188448; tianyh@ahmu.edu.cn

Hongping Wang

CONTACT

+86-18256001073; medstuwhp@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of the First Affiliated Hospital of the University of Science and Technology of China

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 28, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

CN (1)