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临床试验/NCT02213601
NCT02213601已完成不适用

Efficacy of Yoga for Depressed Postpartum Women: A Randomized Controlled Trial

University of Iowa2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
2
主要终点
Change from baseline in depression on the 17-item Hamilton Depression Rating Scale (HDRS) at week 8

研究概览

简要总结

The aim of this project is to compare the efficacy of an 8-week yoga intervention, relative to a wait-list control (WLC) condition, for improving psychological functioning and health-related quality of life in depressed postpartum women. It was hypothesized that the yoga intervention would be significantly more efficacious than the wait-list control condition in reducing symptoms of depression and anxiety, and improving health-related quality of life, at the end of the 8-week yoga intervention.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Score of 12 or greater on the 17-item Hamilton Depressing Rating Scale
  • Participant must reside within a 30 mile radius of the yoga studios
  • ≥ 6 weeks postpartum if delivery was either complicated and/or involved a cesarean section

排除标准

  • Current or past diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, alcohol or drug abuse/dependence (except nicotine), or anorexia in the past year
  • Acute suicidal or homicidal risk
  • Current mental health treatment, including psychotropic medications or psychotherapy with a certified therapist
  • St. John's Wort or Fish oil
  • Practiced yoga at a studio with a certified yoga instructor within the past month
  • Significant medical disorder (e.g., seizure disorder) that is contraindicated for exercise in postpartum women

结局指标

主要结局

Change from baseline in depression on the 17-item Hamilton Depression Rating Scale (HDRS) at week 8

时间窗: Baseline, Week 8

The Hamilton Depression Rating Scale (HDRS) is a validated and reliable measure of the severity of depressive symptoms, and is used extensively in depression treatment studies. The 17-item HDRS is sensitive to treatment change in the postpartum population, and is a valid indicator of depression severity in postpartum depression despite the overlap between somatic HDRS items and typical experiences of postpartum women.

次要结局

  • Change from baseline in traumatic intrusion symptoms on the Inventory of Depression and Anxiety Symptoms Traumatic Intrusions Scale (IDAS) at week 8(Baseline, Week 8)
  • Change from baseline in panic symptoms on the Inventory of Depression and Anxiety Symptoms Panic Scale (IDAS) at week 8(Baseline, Week 8)
  • Change from baseline in social anxiety symptoms on the Inventory of Depression and Anxiety Symptoms Social Anxiety Scale (IDAS) at week 8(Baseline, Week 8)
  • Change from baseline in health-related quality of life symptoms on the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) at week 8(Baseline, Week 8)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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