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临床试验/NCT05299190
NCT05299190撤回不适用

Feasibility, Acceptability and Preliminary Efficacy of a Hospital-based Antenatal Yoga Program for Anxious and Depressed Women

Hopital Montfort0 个研究点开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Edinburgh Postnatal Depression Scale

研究概览

简要总结

The aim of this study is to determine if a hospital-based antenatal yoga program (HB-AYP) is a feasible, acceptable and potentially efficacious intervention for women with antenatal anxiety and/or depression?

详细描述

Anxiety and depression are the most common psychological symptoms reported in pregnant women and can result in adverse obstetric, neonatal and post-partum mental health outcomes. Although there is a range of effective first-line treatments for anxiety and depression, these treatments are not without limitations. Concerns about the safety of antidepressant medication during pregnancy, lack of access to affordable psychosocial treatments and reluctance to seek mental health care due to stigma may prevent pregnant women from receiving optimal care for their symptoms. Recently, there has been growing interest in alternative and complementary approaches to manage anxiety and depression. These approaches may offer women with antenatal anxiety and depression an alternative treatment option that may be more acceptable and perceived as more holistic and less stigmatizing than conventional mental health care. One way to optimize access to yoga therapy during prenatal care is to implement an antenatal yoga program within a public healthcare system. Accordingly, the overarching aim of this study is to evaluate the feasibility of a hospital-based antenatal yoga program (HB-AYP) plus treatment as usual for anxiety and depression, and obtain preliminary data on its potential efficacy relative to treatment as usual plus biweekly clinical monitoring(TAU) This pilot research will provide much needed preliminary data that will set the foundation for designing a fully-powered prospective randomized controlled trial (RCT) of a HB-AYP. In the long term, it is hoped that this line of research will influence evidence-based clinical guidelines for managing antenatal anxiety and depression and service delivery.

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)

盲法说明

The MINI will be administered at 6-months post-partum by a blind assessor

入排标准

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

入选标准

  • Healthy women in their second trimester of an uncomplicated pregnancy with elevated levels of anxiety and/or depression (based on the PHQ-9 and GAD-7) will be eligible to participate

排除标准

  • i) a lifetime history of psychosis, ii) symptoms of mania/hypomania in the past 12 months; iii) a history of substance use disorders in the last 6 months; iv) a history of self-harm in the last 6 months; v) high suicide risk; vi) engaged in a regular formal meditative practice at least once a month over the past 12 months; and vii) yoga postures are contraindicated.

结局指标

主要结局

Edinburgh Postnatal Depression Scale

时间窗: Baseline; week 4; week 8; bimonthly until 6 months postpartium

measure of depressive symptoms

次要结局

  • Dyadic Adjustment Scale(Baseline; Week 8; 6-months post-partum)
  • Five Facet Mindfulness Scale(Baseline; Week 8; 6-months post-partum)
  • Perceived Stress Scale(Baseline; Week 8; bimonthly until 6-months postpartum;)
  • Self-Compassion Scale(Baseline; Week 8; 6-months post-partum)
  • Prenatal Attachment Inventory(Baseline; Week 8)
  • Post-partum bonding questionnaire(6-months postpartum)
  • Interpersonal Relationships Inventory (interpersonal support subscale)(Baseline; Week 8; 6-months post-partum)

研究者

申办方类型
Other
责任方
Sponsor

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