TIS for NSSI in Adolescent Depression

Efficacy and Safety of Temporal Interference Stimulation on Non-suicidal Self-injury Behaviors in Adolescents With Depression

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).

Study Overview

• Status: Recruiting
• Conditions: Major Depressive Disorder; Non Suicidal Self Injury; Temporal Interference Stimulation
• Intervention / Treatment: Device: Active Temporal Interference Stimulation (TIS); Device: Sham Temporal Interference Stimulation (TIS)

Detailed Description

The study will evaluate the efficacy and safety of TIS in depressive patients with NSSI behaviors by measuring changes in clinical ratings at baseline, after all the treatments, and 2 weeks, 4 weeks, 8 weeks after treatment. 60 inpatients will be randomized to receive active or sham interventions administered to the right subgenual anterior cingulate cortex. The treatment will apply TIS involving 2x daily at 30 minutes for 5-7 days.

Changes in mood from baseline to the end of the study will be measured with The Hamilton Rating Scale for Depression-17 item (HAMD-17), Hamilton Anxiety Scale (HAMA). Non-suicidal self injury will be assessed by the Adolescent Non-Suicidal Self-Injury Assessment Questionnaire (ANSAQ). Suicidal ideation and behaviors assessments will be measured with Beck Suicidal Scale Inventory (BSI). Changes in somatic symptom severity from baseline to the end of the study will be measured with the Patient Health Questionnaire-15 (PHQ-15). Sleep quality and disturbances will be assessed by the Pittsburgh Sleep Quality Index (PSQI). Insomnia severity will be evaluated using the Insomnia Severity Index (ISI). Ruminative thinking styles will be measured with the Ruminative Responses Scale (RRS). Impulsivity and aggression assessments will be measured with the Barratt Impulsiveness Scale (BIS) and the Buss-Perry Aggression Questionnaire (BPAQ), respectively. Additionally, pain-related attention and hypervigilance will be assessed by the Pain Vigilance and Awareness Questionnaire (PVAQ). Adverse event record form (AERF) will be used to appraise the safety of TIS treatment. Changes of brain structure and brain activities will be acquired by pre and post-interventional magnetic resonance imaging (MRI).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanghua Tian, PhD; Phone Number: +86-13955188448; Email: tianyh@ahmu.edu.cn
• Study Contact Backup: Name: Hongping Wang; Phone Number: +86-18256001073; Email: medstuwhp@126.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • Recruiting
      • The Second Affiliated Hospital of Anhui Medical University
      • Contact: Hongping Wang; Phone Number: +86-18256001073; Email: medstuwhp@126.com
      • Contact: Yanghua Tian, PhD; Phone Number: 0551 6599 7278; Email: tianyh@ahmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

-

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.

   -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: real stimulation; Participants will receive active TIS 10 to 14 times.	Device: Active Temporal Interference Stimulation (TIS); 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.
Sham Comparator: sham stimulation; Participants will receive sham TIS 10 to 14 times.	Device: Sham Temporal Interference Stimulation (TIS); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Hamilton Anxiety Scale (HAMA)	Range from 0-56, 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
Change in the Patient Health Questionnaire-15 (PHQ-15)	Range from 0 to 30, higher score indicates more severe somatic 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
Changes in Insomnia Severity Index (ISI)	Range from 0 to 28. Higher scores indicate more severe insomnia 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
Changes in Ruminative Responses Scale (RRS)	Range from 22 to 88. Higher scores indicate higher levels of ruminative thinking.	Baseline, the day after the end of TIS
Changes in Beck Suicidal Scale Inventory (BSI)	Range from 0- 38, higher score indicates more severe suicide ideation.	Baseline, the day after the end of TIS
Chinese version of the Barratt Impulsiveness Scale	Total score ranges from 0 to 100. It is converted from a 30-item raw score based on a 5-point scale. Higher scores indicate greater levels of impulsivity.	Baseline, the day after the end of TIS
Changes in the Chinese version of the Buss & Perry Aggression Questionnaire	Total score ranges from 0 to 100. It is mathematically converted from the sum of the raw item scores. Higher scores indicate greater levels of aggression.	Baseline, the day after the end of TIS
Changes in Pain Vigilance and Awareness Questionnaire (PVAQ)	Range from 0 to 80. Higher scores indicate greater pain-related attention and hypervigilance.	Baseline, the day after the end of TIS
Changes of high-resolution T1-weighted anatomical images	T1-weighted images will be acquired using 3D inversion recovery-prepared fast spoiled gradient-echo sequences.	Baseline, the day after the end of TIS
Changes of blood oxygenation level dependent (BOLD) functional imaging signals	Resting-state MRI (rs-MRI) will be used to exam the change of brain function.	Baseline, the day after the end of TIS
Changes of Diffusion Tensor Imaging	Diffusion Tensor Imaging (DTI) will be performed using diffusion-weighted echo planar imaging sequences.	Baseline, the day after the end of TIS

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the Pittsburgh Sleep Quality Index (PSQI)	Total score ranges from 0 to 21. Higher scores indicate poorer overall sleep quality and more severe sleep disturbances.	Baseline
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Recording any side effects in the adverse event record form (AERF).	The day after the end of TIS

Collaborators and Investigators

• Sponsor: The Second Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depressive Disorder; Behavior; Depressive Disorder, Major; Self-Injurious Behavior
• Other Study ID Numbers: AHMU-TIS-NSSI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No