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.
研究组 & 干预措施
Traditional Acupuncture
Patients will be treated at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, and unilateral Yintang EX-HN3 and Baihui GV20. Acupuncture treatment will be performed by a registered Chinese medicine practitioner. "De qi"(an irradiating feeling considered to be indicative of effective needling) is achieved if possible. An electric-stimulator (CEFAR Acus II, Lund, Sweden) is connected to these needles to give an electric-stimulation in continuous wave, frequency of 4 Hz, 0.45 ms square wave pulses and constant current. Surgical tape or hair pin will be adhered to the needles.The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.
干预措施: Acupuncture (Other)
Minimal Acupuncture
Patients will be treated superficially at points away from classic acupoints. The points include bilateral "Deltoideus" [in the middle of the line insertion of Binao LI 14 and acromion], "Forearm" [1 inch laterally of the middle point between Shaohai HE3 and Shenmen HE7], "Upper arm" [1 inch laterally of Tianfu LU 3] and "Lower leg" [0.5 inch dorsally of Xuanzhong GB39]. "De qi" is avoided during needling. The treatment procedure, electric-stimulation, frequency, duration and number of treatment sessions will be the same for the Traditional Acupuncture group.
干预措施: Acupuncture (Other)
Placebo Acupuncture
Placebo needles designed by Streitberger (1998) will be used. The placebo needles are blunt needle that will not penetrate the skin during needle insertion. The handles of these placebo needles will slide over the needle when it is compressed, giving it the appearance of penetrating the skin. The placebo needles are inserted to the site 1 inch beside the acupoints in order to avoid the acupressure effect. The needles are held by a surgical tape or hair pin in hairy region to imitate the retention of needles. The needles are connected to an electric-stimulator with zero frequency and amplitude. The number, duration and frequency of the treatment sessions, and the intervention procedure will be the same for electro-acupuncture and placebo acupuncture.
干预措施: Acupuncture (Other)
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.)