NCT01707706已完成不适用
A Randomized Controlled Trial of Electroacupuncture for Persistent Insomnia Symptoms Associated With Major Depressive Disorder
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Self-rated sleep quality score changes from baseline to 5-week posttreatment measured by Insomnia Severity Index questionnaire
研究概览
简要总结
The purpose of this study is to evaluate the clinical effectiveness of acupuncture treatment on residual insomnia in major depressive patients.
详细描述
This is a randomized single-blinded controlled trial. Patients will be randomly assigned to one of the three groups. One is the traditional acupuncture treatment group, one is the non-traditional acupuncture treatment group and the other is an acupuncture-like placebo treatment. Patients will be put into groups and then compared. The chance of getting into each group is 2:2:1.
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 (Participant)
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
- •Aged 18 years or above
- •A previous Diagnostic and Statistical Manual of Mental Disorders-IV Major Depressive Disorder
- •Have a current Diagnostic and Statistical Manual of Mental Disorders-IV diagnosis of insomnia disorder
- •Insomnia more than 3 nights per week for at least 3 months
- •Insomnia Severity Scale (ISI) total score higher than 15 at screening and baseline visit
- •Use of antidepressants at the same dosage for at least 12 weeks prior to screening visit
- •Hypnotic dosage has not been increased in the last 4 weeks
排除标准
- •Have a Hamilton Depression Rating Scale scores above 18
- •Have sleep apnea or periodic limbs movement disorder detected by overnight polysomnography
- •Have suicidal risk as assessed by the Hamilton Depression Rating Scale suicidal risk item
- •Have previous history of schizophrenia, other psychotic disorders, and bipolar disorder
- •Have current alcohol or drug abuse and dependence
- •Pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception
- •Have infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe
- •Taking Chinese herbal medicine or over-the-counter drugs which are intending for insomnia within the last 2 weeks prior to baseline or during the study
- •Any acupuncture treatment during the previous 12 months prior to baseline and
- •Unstable medical conditions.
结局指标
主要结局
Self-rated sleep quality score changes from baseline to 5-week posttreatment measured by Insomnia Severity Index questionnaire
时间窗: Baseline, 1-week and 5-week posttreatment.
次要结局
- Subjective report of painful and non-painful somatic symptoms measured by Somatic Symptom Inventory (SSI)(Baseline, 1-week posttreatment, and 5-week posttreatment.)
- Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS)(Baseline, 1-week posttreatment and 5-week posttreatment)
- Self-rated assessment regarding the degree of catastrophic thoughts about pain measured by Pain Catastrophizing Scale (PCS)(Baseline, 1-week posttreatment, and 5-week posttreatment.)
- Subjects' general health and quality of life regarding physical functioning, social functioning, physical role limitations, emotional role limitations, mental health, vitality, bodily pain, and general health perception measured by Short form -36 (SF-36)(Baseline, 1-week posttreatment, and 5-week posttreatment.)
- Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)(Baseline, 1-week posttreatment, and 5-week posttreatment)
- Depression state measured by Hamilton Depression Rating Scale (HAMD)(Baseline, 1-week posttreatment, and 5-week posttreatment.)
- Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire(Baseline, 1-week posttreatment, and 5-week posttreatment.)
- Depression state measured by Hamilton Anxiety Rating Scale (HAMA)(Baseline, 1-week posttreatment, and 5-week posttreatment)
- Self-rated severity of depressive and anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS)(Baseline, 1-week posttreatment, and 5-week posttreatment)
- Subjects' credibility to the treatment measured by Credibility of treatment rating scale(Baseline, second treatment (expected 3-day post-baseline ) and the last time of the treatment (expected 19-day post-baseline ))
- Serious adverse events measured by Serious Adverse Event (SAE)(1-week, 2-week, and 3-week post-baseline, 1-week and 5-week posttreatment)
- Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) changes from baseline to 5-week posttreatment by objective measure - wrist actigraphy(Baseline, 1-week posttreatment, and 5-week posttreatment.)
- Potential adverse events related to acupuncture measured by Adverse Events Report Related to Acupuncture(1-week, 2-week, and 3-week post-baseline, 1-week and 5-week posttreatment)
- Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) changes from baseline to 5-week posttreatment by subjective measures using sleep log.(Baseline, 1-week posttreatment, and 5-week posttreatment.)
研究者
研究点 (1)
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