A Randomized Controlled Trial of Acupuncture for Residual Insomnia Associated With Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Self-rated sleep quality score 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 1:1:1, i.e. equal chance.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to give informed consent;
- •Hong Kong resident;
- •Age 18-65 years;
- •Previous DSM-IV Major Depressive Disorder as confirmed with the Structured Clinical Interview for DSM-IV;
- •Hamilton Depression Rating Scale scores of 18 or below for at screening and baseline visit;
- •A chief complaint of insomnia;
- •Able to comply with the trial protocol.
排除标准
- •Any symptoms suggestive of specific sleep disorders, including loud snoring, periodic leg movement, parasomnia;
- •A diagnosis of sleep apnea or periodic limb movement disorder (PLMD) as assessed by overnight polysomnography (PSG);
- •Presence of suicidal risk;
- •Previous history of schizophrenia, other psychotic disorders, and bipolar disorder;
- •Pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception;
- •Infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe.
结局指标
主要结局
Self-rated sleep quality score measured by Insomnia Severity Index questionnaire
时间窗: Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.
Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by objective measure - wrist actigraphy
时间窗: Baseline, 1-week posttreatment, and 4-week posttreatment.
Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by subjective measures using sleep log.
时间窗: Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.
次要结局
- Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire(Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.)
- Depression state measured by Hamilton Depression Rating Scale (HAMD)(Baseline, 1-week posttreatment, and 4-week posttreatment.)
- Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale(Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.)
- Subjects' credibility to the treatment measured by Credibility of treatment rating scale(Second and the last time of the treatment.)