Efficacy and Safety of Electroacupuncture on Treating Depression Related Insomnia: Study Protocol for a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
The investigators describe a protocol for a multicenter randomized controlled trial to find out the efficacy of electroacupuncture for depression related insomnia.
详细描述
Sleep difficulties are among the main symptoms presented by depressed patients, and they can profoundly impact course of illness. Acupuncture is a widely recognized therapy to treat depressive disorders and sleep disturbances in clinical practice. This multicenter randomized placebo-controlled trial is aimed to investigate the efficacy and safety of electroacupuncture, sham acupuncture and standard medical care, administrated by professional acupuncturists and psychiatrists, in depression patients with insomnia.
The investigators describe a protocol for a multicenter randomized controlled trial. Two hundred seventy eligible patients in 3 different health-care centers in Shanghai will be randomly assigned to one of 3 treatment groups: EA group (electroacupuncture+standard medical care), Control A group (sham acupuncture+standard medical care) and Control B group (standard medical care). Treatment will be given 3 times per week for 8 weeks. The primary outcomes is the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes are sleep parameters recorded in the Actigraphy, Hamilton Rating Scale for Depression (HAMD) score and Self-rating Anxiety Scale (SAS) score. Daily dose of patients' antidepressant and sedative-hypnotic medication will be recorded in the dairy. All adverse effects will be assessed by the Treatment Emergent Symptom Scale (TESS). Outcomes will be evaluated at baseline, 4 weeks post-treatment and 8 weeks post-treatment, as well as at 1 month, 3 months and 6 months follow-up.
The findings from this trial will help further about the efficacy and safety of acupuncture for depression related insomnia, as well as determine the differences between electroacupuncture, sham acupuncture and standard medical care for treating insomnia and depression.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants aged 18-70;
- •Participants who meet the diagnostic criteria of depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV);
- •Participants whose HAMD score is 20-35;
- •Participants who have complaint about insomnia at the first visit to the doctor;
- •Participants whose PSQI score is more than 7;
- •Participants who voluntarily agree with the investigation and sign a written informed consent form for the clinical trial.
排除标准
- •Participants with secondary depressive disorders caused by organic diseases, medicine, or psychotic disorders including schizophrenia, etc;
- •Participants who are in the depressive episode of bipolar disorder, or suffering from dysthymia, reactive depression and depressive syndrome caused by other diseases;
- •Participants with alcohol abuse or drug dependence;
- •Participants who refuse to wear the Actigraphy during the trial;
- •Pregnant or lactating women.
研究组 & 干预措施
Electroacupuncture group
electroacupuncture+standard care
干预措施: Electroacupuncture(EA) (Device)
Control A group
placebo acupuncture+standard care
干预措施: Placebo acupuncture (Device)
Control B group
standard care
干预措施: Standard care (Other)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: 8 week post-treatment
The Pittsburgh Sleep Quality Index (PSQI) is a widely-used questionnaire to assess one's sleep disorders over one month. It is comprised of 19 self-rated items and 5 other-rated items. The scores include the following indicators: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of medication, and daytime dysfunction. Each indicator is rated from 0 to 3. The accumulated scores of the seven indicators constitute the total score of PSQI (0-21). The higher score indicates the worse sleep quality and severer sleep disorders. The investigators set the PSQI score at 8th week post-treatment as the primary outcome, compared with PSQI scores at other time points, to evaluate the effectiveness of acupuncture for depression related insomnia.
次要结局
- Self-rating Anxiety Scale (SAS)(baseline, 4 week, 8 week post-treatment)
- Actigraphy(baseline, 4 week post-treatment, 8 week post-treatment)
- Hamilton Rating Scale for Depression (HAMD)(baseline, 4 week post-treatment, 8 week post-treatment, 1 month, 3 month, 6 month follow-up)
- Changes of PSQI scores from baseline to 6 month follow-up(baseline, 4 week post-treatment, 8 week post-treatment, 1 month,3 month, 6 month follow-up)
- Dose dairy(baseline, 4 week, 8 week post-treatment, 1 month, 3 month, 6 month follow-up)