Pilot Study on the Use of Acupuncture for Postpartum Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- 17-item Hamilton Depression Rating Scale
研究概览
简要总结
The proposed study is a randomized controlled trial to examine the efficacy and safety of active acupuncture versus placebo acupuncture for the treatment of postpartum depression. The investigators hypothesis is that active acupuncture would be superior to placebo acupuncture in the short-term treatment of postpartum depression.
详细描述
This study will be a randomized, controlled, subject- and assessor-blind trial in patients with postpartum depression. Eligible subjects will be randomly assigned to active acupuncture or placebo acupuncture. The subjects will receive acupuncture treatment twice per week for 4 consecutive weeks. The acupuncturist of this trial will not participate in data collection and data entry. The trial assessor will be blind to the subjects' treatment allocation.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ethnic Hong Kong Chinese aged 18 years or above;
- •Within 6 months of giving birth;
- •Edinburgh Postnatal Depression Scale (EPDS) (Cox et al., 1987) score higher than or equal to 12 or being diagnosed as depressed by their obstetrician;
- •Meeting the Diagnostic and Statistical Manual of Mental Disorders-IV diagnosis criteria for major depressive disorder;
- •17-item Hamilton Depression Rating Scale (HDRS17) (Hamilton, 1960) score of between 12 and 19 at screening and baseline assessment;
- •Willingness to give informed consent and comply with trial protocol.
排除标准
- •Suffering from other psychiatric disorders such as schizophrenia, other psychotic disorders, bipolar disorder or substance use disorder;
- •Serious physical illnesses or mental disorders due to a general medical condition which are judged by the investigator to render unsafe;
- •A significant risk of suicide according to the rating of HDRS17 item 3 (score higher than 2), i.e., presence of ideas or gesture of suicide;
- •A presence of idea of self-harming according to the rating of EPDS item 10 (score higher than 0);
- •A significant risk of infanticide according to the investigator assessment;
- •Any acupuncture treatment during the previous 12 months prior to baseline;
- •Valvular heart defects, bleeding disorders or taking anticoagulant drugs;
- •Infection or abscess close to the site of selected acupoints;
- •Herbal remedies or psychotropic drugs that are intended for depression are taken within the last 2 weeks prior to baseline or during the study.
- •Receiving counseling or psychological therapies at baseline or during the study;
- •Participation in any clinical trial within the previous 3 months prior to baseline;
研究组 & 干预措施
Active acupuncture group
Active acupuncture regimen consists of electroacupuncture stimulation on cranial and body acupoints.
干预措施: Active acupuncture (Procedure)
Placebo acupuncture group
Streitberger's non-invasive acupuncture needles will be applied to serve as placebo control at the same acupoints and the same stimulation modality, except that the needles only affixed on the skin with adhesive tapes instead of insertion. Since all the points used are beyond patients' vision as they lay on bed, they could not visualize the acupuncture procedure. The acupuncturist, setting, treatment frequency, and duration of the treatment course are the same as the active acupuncture group.
干预措施: Placebo acupuncture (Procedure)
结局指标
主要结局
17-item Hamilton Depression Rating Scale
时间窗: 8 weeks
To assess Depressive symptoms
次要结局
- Hospital Anxiety and Depression Scale (HADS)(8 weeks)
- Sheehan Disability Scale(8 weeks)
- Clinical Global Impression Scale(8 weeks)
- Edinburgh Postnatal Depression Scale(8 weeks)
研究者
Dr. Chung Ka-Fai
Clinical Associate Professor
The University of Hong Kong