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临床试验/NCT03026959
NCT03026959已完成不适用

The Role of Mindfulness Skills Training in Maternal Mental Health: A Randomized Controlled Trial

Lakehead University2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2016年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
Altman Self-Rating Mania Scale

研究概览

简要总结

There is preliminary empirical support for the use of mindfulness interventions during the perinatal period; suggesting that mindfulness training may be an effective treatment approach for reducing depression and anxiety symptoms during pregnancy and reducing anxiety, stress, and psychological distress during the postpartum period. To extend on these findings, the purpose of this research is to evaluate the effectiveness of a brief mindfulness-based program in protecting maternal mental health and well-being using a randomized controlled trial.

详细描述

Based on the results reported in the existing literature that show that formal mindfulness-based practice is effective for improving mental health status and preventing depressive symptom relapse, this research aims to evaluate the effectiveness of a brief mindfulness-based program, offered during pregnancy, in reducing mothers' psychological symptoms during pregnancy and the postpartum period. A brief program has the advantage being more economical to facilitate compared to full-length programs and also requires a shorter commitment from pregnant women, who are also attempting to manage multiple other new and existing demands (e.g., obstetrics appointments, work).

As emerging research suggests that women are particularly vulnerable to increased depressive, anxious, obsessive, compulsive, and hypomanic symptoms during the perinatal period these are the main psychological symptoms that will be assessed. As well, perceived stress and psychological resiliency will also be assessed for in order to examine changes in these domains in relation to mindfulness engagement. Furthermore, as a reduction in maternal psychological symptoms has been reported to have implications for mother-infant bond, the mother's interpersonal functioning, and maternal quality of life, the investigators will also assess to see if there are corresponding changes in these domains related to mindfulness engagement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • pregnant, age 18 years and older, able and willing to attend the study site for the four group sessions.

排除标准

  • presence of a current severe mental health condition or mental heath difficulties that would be better addressed through another form of therapy, active major medical illness including significant obstetric complications, inability to give informed consent, inability to speak or understand English, at high risk for delivery before reaching full term (38 weeks gestation), or previous completion of a structured mindfulness-based program.

研究组 & 干预措施

Mindfulness Group

Experimental

Participants assigned to the mindfulness group will attend four weekly sessions that are each 1.5 hours in length. The sessions will follow the structure described by Short, Mazmanian, Ozen, & Bédard (2015). The structure is designed to first enhance learners' foundation skills in mindfulness and progresses into teaching learners more advanced mindfulness skills.

干预措施: Mindfulness (Behavioral)

Social (control) Group

No Intervention

Participants assigned to the social group will also attend four weekly sessions that are each 1.5 hours in length. Each session will have participants focus on a creative tasks while permitting task related discussion. In this way the format is designed to parallel the mindfulness group, where participants engage in a new activity each week and have an opportunity to discuss the activities with the group without engaging in any formal intervention.

结局指标

主要结局

Altman Self-Rating Mania Scale

时间窗: 12 weeks postpartum

Obsessive-Compulsive Inventory-Revised

时间窗: 12 weeks postpartum

Edinburgh Postnatal Depression Scale

时间窗: 12 weeks postpartum

Five Facet Mindfulness Questionnaire

时间窗: 12 weeks postpartum

Hospital Anxiety and Depression Scale - Anxiety Subscale

时间窗: 12 weeks postpartum

次要结局

  • Perceived Stress Scale(12 weeks postpartum)
  • Postpartum Bonding Questionnaire(12 weeks postpartum)
  • World Health Organization Quality of Life Scale(12 weeks postpartum)
  • Brief Resilience Scale(12 weeks postpartum)
  • Multidimensional Scale of Perceived Social Support(12 weeks postpartum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dwight Mazmanian

Professor

Lakehead University

研究点 (2)

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