A Randomized Controlled Trial of Mindfulness Based Cognitive Therapy for Psychological Distress in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 4
- 主要终点
- Change in Edinburgh Postpartum Depression Scale scores from baseline to 3 months follow-up postpartum
研究概览
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.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
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
研究组 & 干预措施
MBCT + Treatment as Usual (TAU)
Behavioural: Mindfulness Based Cognitive Therapy
Participants in the MBCT group attend an 8 week course of a modified MBCT program for pregnant women, delivered by a licensed clinical psychologist.
干预措施: Mindfulness Based Cognitive Therapy (Behavioral)
Treatment as Usual (TAU)
Participants in the TAU group access community resources for pregnant women experiencing psychological distress.
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))
研究者
Lianne Tomfohr-Madsen
Assistant Professor of Psychology
University of Calgary