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临床试验/NCT07047534
NCT07047534已完成不适用

Real-time EEG-Triggered Transcranial Magnetic Stimulation Combined With Group Therapy for Adolescents With Depression and Self-Harm Behavior: A Randomized Controlled Trial

The First Hospital of Hebei Medical University2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
2
主要终点
Change in Hamilton Depression Rating Scale (HAMD-24) scores

研究概览

简要总结

This randomized controlled trial aims to evaluate the efficacy of real-time EEG-triggered repetitive transcranial magnetic stimulation (rTMS) combined with group therapy versus rTMS alone in adolescents (aged 12-18 years) diagnosed with depression and exhibiting recent self-harm behavior. The primary outcome is the change in depression severity at 4 weeks.

详细描述

Adolescent depression is a prevalent and severe mood disorder, often comorbid with self-harm behavior, significantly impairing functioning. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique showing promise in depression treatment. Real-time EEG-triggered rTMS (rEEG-TMS) further refines this by synchronizing stimulation with individual neural rhythms, potentially enhancing precision and efficacy. Psychosocial interventions, such as group therapy, are crucial for adolescent mood disorders, offering peer support, emotional regulation skills, and cognitive restructuring. This study investigates whether combining rEEG-TMS with group therapy offers synergistic benefits over rEEG-TMS alone in adolescents with depression and self-harm.

This was a parallel-group randomized controlled trial. A total of 160 inpatients aged 12-18 years with a diagnosis of major depressive disorder (ICD-10 F32) and documented self-harm behavior within 2 weeks prior to enrollment were recruited. Participants were randomized 1:1 to either receive real-time EEG-triggered rTMS alone (control group, n=80) or real-time EEG-triggered rTMS plus group therapy (observation group, n=80). The rTMS intervention consisted of 20 sessions over 4 weeks (5 sessions/week), targeting the left dorsolateral prefrontal cortex (DLPFC) at 10 Hz, 110% of resting motor threshold, with 2000 pulses per session, triggered by the peak of the participant's ongoing θ-wave activity. The group therapy intervention, for the observation group, consisted of 8 semi-closed sessions (2 sessions/week for 4 weeks, 90 minutes/session) covering emotional recognition, cognitive restructuring, impulse control, and self-esteem building. Assessments were conducted at baseline and at 4 weeks post-intervention.

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
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 12-18 years;
  • Diagnosis of major depressive disorder (MDD) according to the International Classification of Diseases, 10th Revision (ICD-10 F32);
  • Documented self-harm behavior within 2 weeks prior to enrollment (defined as deliberate self-injury without suicidal intent, e.g., cutting, burning);
  • Hamilton Depression Rating Scale (HAMD-24) score ≥17 at baseline;
  • Ability to complete self-report measures and participate in group therapy.

排除标准

  • Comorbid psychotic disorders (e.g., schizophrenia), bipolar disorder, or autism spectrum disorder;
  • History of neurological conditions (e.g., epilepsy, traumatic brain injury);
  • Current use of electroconvulsive therapy;
  • Refusal to provide informed consent.

结局指标

主要结局

Change in Hamilton Depression Rating Scale (HAMD-24) scores

时间窗: Baseline and Week 4 (post-intervention)

The HAMD-24 is a clinician-rated scale to assess the severity of depressive symptoms. Higher scores indicate greater severity of depression. Change is calculated as score at week 4 minus score at baseline.

次要结局

  • Change in Hamilton Anxiety Rating Scale (HAMA-14) scores(Baseline and Week 4)
  • Change in Modified Self-Harm Inventory (MSHI) scores(Baseline and Week 4)
  • Change in Resting-State EEG α (alpha) Power(Baseline and Week 4)
  • Change in Resting-State EEG θ/β (theta/beta) Ratio(Baseline and Week 4)
  • Change in Suicide Probability Scale (SPS) scores(Baseline and Week 4)
  • Change in Event-Related Potential (ERP) P300 Latency(Baseline and Week 4)
  • Change in Event-Related Potential (ERP) P300 Amplitude(Baseline and Week 4)
  • Change in Resting-State EEG θ (theta) Power(Baseline and Week 4)
  • Change in Hamilton Anxiety Rating Scale (HAMA-14) scores(Baseline and Week 4)
  • Change in Suicide Probability Scale (SPS) scores(Baseline and Week 4)
  • Change in Event-Related Potential (ERP) P300 Latency(Baseline and Week 4)
  • Change in Event-Related Potential (ERP) P300 Amplitude(Baseline and Week 4)
  • Change in Resting-State EEG θ (theta) Power(Baseline and Week 4)
  • Change in Resting-State EEG θ/β (theta/beta) Ratio(Baseline and Week 4)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanju Liu

Principal Investigator

The First Hospital of Hebei Medical University

研究点 (2)

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