Combined Internet-Based Cognitive Behavioral Therapy With Transcranial Magnetic Stimulation for Patients With Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Dimensional Anhedonia Rating Scale (DARS)
研究概览
简要总结
Major Depressive Disorder (MDD) is a common mental health diagnosis. While there are many approaches to the treatment of MDD, current treatments of MDD often do not substantially reduce depressive symptoms among those in need of care. Prior research suggests that combining cognitive-behavioral therapy (CBT) and psychopharmacology can produce optimal treatment outcomes compared to the use of either treatment individually. Transcranial Magnetic Stimulation (TMS) is one promising brain stimulation approach used to treat MDD, especially among patients with treatment-resistant symptoms. Like psychopharmacological interventions, TMS may produce optimal treatment outcomes when paired with CBT. However, standard TMS protocols are time-intensive, typically requiring daily doctor visits for one hour of six to eight weeks. Therefore, an internet-delivered CBT protocol may augment the effects of TMS without substantially increasing patient burden. To that end, the present study assesses if a combined TMS and internet-delivered CBT protocol may produce superior treatment outcomes compared with TMS alone.
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 (Care Provider)
盲法说明
Care providers administering the TMS treatment are blinded and do not know whether the participant has been randomized to receive iCBT or educational content as a supplement to the TMS treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with Major Depressive Disorder who are receiving a full course of TMS treatment in at the UCLA TMS Clinic. Eligibility is determined by TMS physicians who are co-investigators on this study.
排除标准
- •Any indications of metal implants, pregnancy, psychosis, autism spectrum disorders, complex regional pain syndromes, substance use dependence and comorbidities that would interfere with treatment response. The criteria are assessed using MINI interview and Hamilton Depression scale conducted by trained and certified interviewers. Participants may not participate if they are currently completing CBT outside of the study.
结局指标
主要结局
Dimensional Anhedonia Rating Scale (DARS)
时间窗: Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up
Change in Depression Symptoms (Range = 0-130, higher indicates lower symptoms)
Temporal Experience of Pleasure Scale (TEPS)
时间窗: Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up
Change in Depression Symptoms (Range = 0-108, higher indicates lower symptoms)
Hamilton Depression Rating Scale (HAM-D)
时间窗: Baseline to Post-Treatment (6 weeks)
Change in Depression Symptoms (Range = 0-52, higher indicates greater symptoms)
Temporal Experience of Pleasure Scale (TEPS)
时间窗: Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up
Change in Depression Symptoms (Range = 0-108, higher indicates lower symptoms)
Inventory of Depressive Symptomatology (IDS)
时间窗: Baseline to Post-Treatment (6 weeks)
Change in Depression Symptoms (Range = 0-78, higher indicates greater symptoms)
Dimensional Anhedonia Rating Scale (DARS)
时间窗: Baseline to Post-Treatment (6 weeks), as well as 6-month and 9-month follow-up
Change in Depression Symptoms (Range = 0-130, higher indicates lower symptoms)
次要结局
未报告次要终点
研究者
Ben Rosenberg
Postdoctoral Fellow
University of California, Los Angeles