Efficacy and Safety of Temporal Interference Stimulation on Non-suicidal Self-injury Behaviors in Adolescents With Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in the Adolescent Non-Suicidal Self-Injurious Behavior Assessment Questionnaire (ANSAQ)
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •6.Obtain informed consent from patients and guardians
排除标准
- •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.
研究组 & 干预措施
real stimulation
Participants will receive active TIS 10 to 14 times.
干预措施: Active Temporal Interference Stimulation (TIS) (Device)
sham stimulation
Participants will receive sham TIS 10 to 14 times.
干预措施: Sham Temporal Interference Stimulation (TIS) (Device)
结局指标
主要结局
Changes in the Adolescent Non-Suicidal Self-Injurious Behavior Assessment Questionnaire (ANSAQ)
时间窗: 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
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."
Changes in the 17-item Hamilton Rating Scale for Depression (HAMD-17)
时间窗: 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
Range from 0-52, higher score indicates more severe symptoms
次要结局
- 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)
- Chinese version of the Barratt Impulsiveness Scale(Baseline, the day after the end of TIS)
- Changes in the Chinese version of the Buss & Perry Aggression Questionnaire(Baseline, the day after the end of TIS)
- Changes in Pain Vigilance and Awareness Questionnaire (PVAQ)(Baseline, the day after the end of TIS)
- Changes of high-resolution T1-weighted anatomical images(Baseline, the day after the end of TIS)
- Changes of blood oxygenation level dependent (BOLD) functional imaging signals(Baseline, the day after the end of TIS)
- Changes of Diffusion Tensor Imaging(Baseline, the day after the end of TIS)
研究者
Yanghua Tian
President of the First Affiliated Hospital of the University of Science and Technology of China
The Second Hospital of Anhui Medical University