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临床试验/NCT02214732
NCT02214732
已完成
不适用

A Randomized Controlled Trial of Mindfulness Based Cognitive Therapy for Psychological Distress in Pregnancy

University of Calgary2 个研究点 分布在 1 个国家目标入组 61 人2014年8月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Depression
发起方
University of Calgary
入组人数
61
试验地点
2
主要终点
Change in Edinburgh Postpartum Depression Scale scores from baseline to 3 months follow-up postpartum
状态
已完成
最后更新
7年前

概览

简要总结

Anxiety, stress and depression are common during pregnancy and in the postpartum period. The lack of empirically supported, non-pharmaceutical interventions for psychological distress in pregnancy is a significant gap in the literature, especially given many pregnant women's preference for non-pharmaceutical treatments. This study will evaluate the efficacy of Mindfulness Based Cognitive Therapy (MBCT) program in reducing measures of psychological distress (e.g., symptoms of stress, depression and anxiety) in a group of pregnant women endorsing high levels of distress.

注册库
clinicaltrials.gov
开始日期
2014年8月
结束日期
2017年9月
最后更新
7年前
研究类型
Interventional
研究设计
Parallel
性别
Female

研究者

责任方
Principal Investigator
主要研究者

Lianne Tomfohr-Madsen

Assistant Professor of Psychology

University of Calgary

入排标准

入选标准

  • Eligible women for this study
  • are between 12 and 28 weeks of gestation,
  • are experiencing psychological distress (elevated perinatal anxiety, mild depressive symptoms, or high-levels of self-reported stress)

排除标准

  • current suicidality
  • current substance abuse or dependence
  • experience a current major depressive episode
  • have been diagnosed with bipolar disorder or other disorders that have a psychotic, dissociative, hallucinatory, or delusional component
  • taking prescribed medications that affect sleep or mood

结局指标

主要结局

Change in Edinburgh Postpartum Depression Scale scores from baseline to 3 months follow-up postpartum

时间窗: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum (3 months after the birth of a person's baby)

Symptoms of depression will be assessed using the 10-item, self-report Edinburgh Postpartum Depression Scale (EPDS). The EPDS has been validated against interview schedules and other self-report instruments.

次要结局

  • Change in Perceived Stress Scale (PSS-10) scores from baseline to 3 months(Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum)
  • Change in measures of blood pressure (BP) from baseline to 3 months(Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum)
  • Change in objective measures of sleep using Wrist Actigraphy from baseline to 3 months(Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum)
  • Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to 3 months(Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum)
  • Change in salivary cortisol profile from baseline to 3 months(Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum)
  • Changes in measures of heart rate variability from baseline to 3 months(Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum)
  • Change in Pregnancy Related Anxiety Measure scores from baseline to post-treatment(Baseline (Week 1), Post-Treatment (Week 10))

研究点 (2)

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