Effects of Augmentation of Interpersonal Psychotherapy With High-Definition Transcranial Direct Current Stimulation for Adolescent Depression: A Randomized Clinical Trial
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
- Child Depression Rating Scale-Revised
研究概览
简要总结
Depression is among the most prevalent psychiatric disorders, with an upward trend in its manifestation in younger individuals. In contrast to adult depression, adolescent depression often presents with longer attack durations, higher recurrence rates, chronicity, and elevated disability rates. At present, treatment options for adolescent depression encompass pharmacological, physical, and psychological therapies. However, current evidence suggests that no antidepressant medication is entirely safe for youths, with only fluoxetine and escitalopram being FDA-approved for treating adolescent depression.
Given the weight of interpersonal stressors faced by teenagers, the NICE guidelines recommend interpersonal therapy(IPT) as a first-line treatment. A 2020 meta-analysis in the Journal of the American Academy of Child and Adolescent Psychiatry reported that interpersonal therapy exhibited significantly greater improvements in depression symptoms than cognitive behavioral therapy(CBT), although psychotherapeutic effects were modest, achieving a remission rate of 60%. These results underscore the need for further research to enhance interpersonal therapy's effectiveness in treating adolescent depression.
High-Definition Transcranial Direct Current Stimulation (HD-tDCS）is a highly secure non-invasive brain stimulation technique that produces sustained effects even after stimulation has discontinued, rendering it particularly valuable for therapeutic interventions. The proposed study aims to augment a single IPT treatment with HD-tDCS stimulation for adolescent depression. By enhancing the excitability of the cerebral cortex, HD-tDCS could potentially enhance IPT's therapeutic efficacy in treating adolescent depression while facilitating further investigation of its underlying neural circuit mechanisms.
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
- Double (Participant, 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
- 否
入选标准
- •Sign a written informed consent form, willing to participate in the study and accept treatment (patients under 18 years of age need to obtain the consent of their parents or legal guardians);
- •Age between 12 and 18 years;
- •Right-handed;
- •Han ethnicity;
- •Meet the DSM-5 diagnostic criteria for depression;
- •HAMD-24≥20;
- •Understand written language and able to complete questionnaires;
- •First-episode depression patients who have never received any treatment or relapse depression patients, have not taken any psychotropic drugs in the past 2 weeks, have not received systematic psychological or physical therapy.
排除标准
- •Exclusion criteria for tDCS: (1) Patients with metal implants in the body; those with metal implants such as titanium or magnetic devices (including aneurysm clips); (2) Patients with implanted devices such as cardiac pacemakers, deep brain stimulators (DBS); (3) Patients with intracranial hypertension, skull defects, or tumors; (4) Patients with unstable vital signs such as severe cardiac or somatic diseases; (5) Patients in the acute phase of cerebrovascular diseases; (6) Patients with adverse reactions to electrical stimulation; (7) Patients with pain sensitivity, injury, or inflammation in the stimulation area.
- •Exclusion criteria for MRI;
- •Patients with severe neurological, cardiac, liver, kidney, endocrine, and blood system diseases, or any other condition that may interfere with the study evaluation;
- •Patients with organic mental disorders and mental retardation;
- •Patients with alcohol or drug dependence;
- •Patients with a high risk of suicide.
结局指标
主要结局
Child Depression Rating Scale-Revised
时间窗: 3-month
Assessment of depressive symptoms. Score\<40: normal; 40\~60: mild or moderate depression; \>60: severe depression.
24-item Hamilton Depression Rating Scale
时间窗: 3-month
Assessment of depressive symptoms. Score\<8: normal; \>20: mild or moderate depression; \>35: severe depression.
次要结局
- The Reflective Function Questionnaire for Youths(3-month)
- 17-item Hamilton Anxiety Rating Scale(3-month)
- Beck Scale for Suicide Ideation(3-month)
- Toronto Alexithymia Scale-20(3-month)
- Emotion Regulation Questionnaire(3-month)
- Comfort Rating Questionnaire(3-month)
- IL-6 level(2-month)
- Thinc-integrated Tools(THINC-it)(2-month)
- the Chinese version of the Snaith-Hamilton Pleasure Scale(3-month)
- MRI data(2-month)
- Distance memory test(2-month)
- Interpersonal Relationship Scale(3-month)
- EEG data(2-month)
- Perceptual judgment test(2-month)
- ERP experiment(2-month)
- TMS-evoked potentials(TEPs)(2-month)