CBT-I Targeting Co-morbid Insomnia in Patients Receiving RTMS for Treatment-Resistant Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Number of Reported Unanticipated Adverse Events
研究概览
简要总结
Depression and insomnia occur together in a substantial number of patients. Transcranial magnetic stimulation (TMS) is an effective treatment for depression, but does not help insomnia symptoms in depressed patients. A form of cognitive behavioral therapy (CBT) has been developed that specifically helps with insomnia (CBT-I). The study team will give CBT-I to patients who are being treated with TMS for depression, who also have insomnia, to determine if it helps insomnia symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-85 years old
- •Patients starting rTMS treatment for MDD
- •Co-morbid insomnia as determined by meeting the following criteria: (a) Requiring more than 30 minutes to fall asleep at the beginning of the night or more than 30 minutes of time awake after initially falling asleep for at least 3 nights per week for at least 3 months - - An insomnia severity index score of 15 or more
- •Manifested sleep disturbances or associated daytime symptoms causing significant distress or impairment in social, occupational or other areas of functioning
- •Reliable access to a computer with internet access.
排除标准
- •Obligation to an irregular sleep schedule that prevents the adoption of intervention strategies such as shift workers
- •Participants who have received or are receiving CBT-I targeting insomnia in the past, or those who have initiated a new sedative medication, or sedating antidepressant within 2-weeks preceding enrollment
- •Comorbid psychiatric disorders, including bipolar disorder, psychotic disorders or depression with psychotic features
- •Presence of another untreated sleep disorder such as obstructive sleep apne
- •Pregnancy
- •Active substance use disorder within the past 3 months
- •Use of medications that reduce the seizure threshold including Buproprion, stimulants or augmenting thyroid medications (for those without history of hypothyroid)
结局指标
主要结局
Number of Reported Unanticipated Adverse Events
时间窗: Baseline through post intervention (6 weeks)
Tolerability of CBT-I with TMS determined by patient reported adverse event as assessed by red cap form
Percentage of patients completing CBT-I program
时间窗: Determined post intervention (6 weeks)
Feasibility of implementation of CBT-I as assessed by completion percentage of patients enrolled.
次要结局
- Change in Epworth Sleepiness Scale(Baseline and post intervention (6 weeks))
- Change in Hamilton Rating Scale for Depression 17(Baseline and post intervention (6 weeks))
- Change in Insomnia Severity Index Scale(Baseline through post intervention (6 weeks))
- Change in Patient Health Questionnaire - 9(Baseline through post intervention (6 weeks))
- Change in Pittsburgh Sleep Quality Index(Baseline and post intervention (6 weeks))