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临床试验/NCT03459053
NCT03459053已完成不适用

CBART: The Reduction of Psychological and Physiological Stress in Women Undergoing IVF

University of Haifa1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2019年4月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
88
试验地点
1
主要终点
Perceived Stress

研究概览

简要总结

The study is a randomized controlled trial of a cognitive behavioral interventions and an art-based stress reduction treatment protocol (CB-ART) with 100 women, identified with elevated perceived stress, before undergoing IVF treatment; in order to examine its effect on perceived stress, plasma CFD, telomere length and pregnancy rates.

CB-ART is a 6-session treatment protocol that has been utilized with women coping with stress, depression and pain and is effective in reducing these indicators, developed and evaluated by our research team. The treatment protocol emphasizes processing together with the client's recalled image, symptom or memory (ISM) pertaining to a current distressing mental or physical state. CB-ART is a multi-method model that integrates cognitive behavioral interventions and art-based stress reduction interventions. The innovation in this method is the transformation of imagined and drawn images and memories rather than solely verbally discussing their contents. The focus is on changing compositional elements that comprise each image and memory, thus providing a therapeutic venue to reframe and transform stress producing, recalled images and memories and reduce symptoms of perceived stress. Art making is beneficial for eliciting an emotional response and provides a concrete platform to conduct the cognitive processing that initiate change on the paper and then in the mind. Furthermore, the soothing qualities of interacting with art making foster and enhance behavioral relaxation techniques.

Our study population, women with infertility problems, who are designated to undergo IVF treatment and have been identified to have elevated perceived stress scores on the Perceived Stress Scale (above 15) will be randomized and allocated to receive the CB-ART intervention tailored to reduce stress or treatment as usual.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Research coordinator will conduct the randomization and all information will be deidentified. Investigator will not know who is in which group.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Hebrew speaking nulliparous women
  • between the ages of 18-35
  • without an axis I psychiatric diagnosis

排除标准

  • Women over 35
  • Do not speak Hebrew
  • Have an Axis I psychiatric diagnosis that would prevent them from participating in the intervention

结局指标

主要结局

Perceived Stress

时间窗: 2 months

The perceived stress scale (Cohen, Kamarck \& Mermelstein, 1994) is a 10 item scale measuring perceived stress by asking 10 questions in which participants are requested to list on a scale from 0- never to 4- very frequently, how often they have experienced different stress related occurrences in the past month. The scale is calculated by summing the items (4 items reversed) with scores ranging from 0 - 40. Higher scores indicate higher perceived stress, with the mean US score being 16.

次要结局

  • Cell Free DNA(2 months)
  • Telomerase(2 months)
  • Pregnancy(2 months)

研究者

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

Johanna Czamanski-Cohen

Lecturer

University of Haifa

研究点 (1)

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