Acupuncture and Massage for Depression During Pregnancy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Depression severity and response status after 8 weeks of treatment
研究概览
简要总结
This study evaluates the efficacy of acupuncture and massage for the treatment of depression during pregnancy. The study also examines differential effects of study treatments on delivery outcome and post partum depression.
详细描述
Participants in this study are randomly assigned to one of the three experimental groups that include two types of acupuncture treatment and perinatal massage. The two acupuncture treatments are delivered in a double-blind fashion. Treatments consist of an acute phase during which participants receive 12 treatment sessions over a period of 8 weeks. Responders and partial responders enter a continuation phase during which they receive weekly treatments that end 10 weeks post delivery. At the end of the continuation phase, participants continue to be clinically assessed at 3 and 6 months after the end of treatment to detail the natural course of relapse to the index episode in the three treatment groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Meet criteria for a current major depressive episode with an HRSD(17) score of at least
- •Ambulatory women (age³18) with a viable pregnancy,
- •Pregnancy between 22 and 30 weeks of gestation
- •Fluent in English
排除标准
- •Meeting criteria for a primary Axis I disorder in past 2 months, other than unipolar depression or social phobia
- •Seasonal affective disorder or episode duration of 2 years or more (chronic depression)
- •Abnormal results on a laboratory screen that will include a thyroid panel and a drug screen.
- •Serious uncontrolled medical conditions or conditions that may be a medical basis of a depression.
- •Cluster B personality disorders.
- •Confounding treatments for depression, including any psychotherapy, herbs, or pharmacotherapy.
- •Current use of any prescribed psychotropic medication or any medication that impacts mood.
- •Treatment with ECT or vagal nerve stimulation during the last year.
- •Current active suicidal potential necessitating immediate treatment.
- •Absence of prenatal care from an OBGYN practitioner in the community.
- •Any condition that necessitates bed rest.
结局指标
主要结局
Depression severity and response status after 8 weeks of treatment
次要结局
- Depression severity at 3, 6, & 9 months post partum; delivery outcome