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临床试验/NCT03404141
NCT03404141Unknown不适用

Psychological Therapy to Reduce Levels of Stress Among Pregnant Women

Universidad de Granada2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Change in hair cortisol levels

研究概览

简要总结

Prenatal stress is associated with negative outcomes such as postpartum depression, prematurity or neurodevelopmental delays.

The aim of this study is to implement a psychological therapy to reduce stress during pregnancy.

详细描述

Objective

To assess whether the group of pregnant women have lower levels of stress after attending the psychological therapy than the group attending parent craft classes.

The cognitive-behavioural therapy to reduce stress will be held in 10 sessions (1 per week) as follows:

First session: General information about pregnancy. Pregnant women will describe what can they do to reduce stress levels.

Second session: Breathing techniques and talk about how last week went. Third session: Muscle relaxation and guided imagination techniques Fourth session: Cognitive restructuring. Being able to detect thoughts and feelings Fifth session: Detect cognitive distortions Sixth session: Cognitive restructuring Seventh session: Time management Eighth session: Problems solving Ninth session: Assertively and social skills Tenth session: How to ask for help when needed and learning to say "No".

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
Double (Participant, Investigator)

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

  • Low risk Pregnant women
  • Gestational age between 10-27 weeks
  • Proficiency in the Spanish language

排除标准

  • Corticoids treatment
  • Gestational Diabetes
  • Psychological diagnosed

结局指标

主要结局

Change in hair cortisol levels

时间窗: Baseline, and 3 months

Change in hair cortisol levels at different time points

次要结局

  • Change in Symptoms Checklist 90 Revised (SCL-90-R)(Baseline, and 3 months)
  • Change in Connor-Davidson Resilience Scale (CD-RISC)(Baseline, and 3 months)
  • Change in Prenatal Distress Questionnaire (PDQ)(Baseline, and 3 months)
  • Change in Perceived Stress Scale (PSS)(Baseline, and 3 months)

研究者

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

Borja Romero-Gonzalez

PhD

Universidad de Granada

研究点 (2)

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