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临床试验/NCT03476200
NCT03476200已完成不适用

Hair Cortisol Concentrations as Indicator of Efficacy of Cognitive Behavioral Therapy

Universidad de Granada2 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2017年2月1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
83
试验地点
2
主要终点
Changes of Hair Cortisol Levels

研究概览

简要总结

Stress is considered as a risk factor for physical and mental health. For this reason, interventional programs focused on stress management have been developed. These programs have proven to be efficacious modifying emotional variables and psychopathological symptoms. However, there are no studies showing how these interventions modify objective measures of stress. For example, measures reflecting Hipotalamic-Pituitary-Adrenal (HPA) axis activity, the main system involved in the stress response. The activity of HPA axis is also altered by illness and psychopathology. Hair cortisol technique allows for changes assessment of HPA axis activity during months. Therefore, hair cortisol may be considered as an useful tool to measure changes of emotional variables related to stress in the long term. This measure of change over time of HPA axis activation together with related emotional variables assessment could be useful to evaluate the efficacy of interventional programs. For this reason, the aim of this research is to assess the effects of a cognitive-behavioral treatment (CBT) on perceived stress, resilience, worries, psychopathology and HPA axis activity through hair cortisol analysis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Member of University of Granada, complete dominance of spanish, high levels of perceived stress.

排除标准

  • Psychopathology, being under psychological treatment.

结局指标

主要结局

Changes of Hair Cortisol Levels

时间窗: Three measures: at the beginning of the study, at three months (when the stress program is finished) and at three months follow up (since the end of the stress program).

The technique measures hypothalamic-pituitary-adrenal axis activation during the last three months, higher levels indicate higher activation of HPA axis.

Changes in "Connor and Davidson Resilience Scale" (CD-RISC) scores.

时间窗: Three measures: at the beginning of the study, at three months (when the stress program is finished) and at three months follow up (since the end of the stress program).

The scale measures resilience as the ability to successfully cope with stress, punctuations range from 0 to 100, higher scores indicate higher levels of resilience.

次要结局

  • Changes in "Nottingham Health Profile" (NHP) scores.(Three measures: at the beginning of the study, at three months (when the stress program is finished) and at three months follow up (since the end of the stress program).)
  • Changes in "Symptoms Checklist-90-Revised" (SCL-90-R) scores.(Three measures: at the beginning of the study, at three months (when the stress program is finished) and at three months follow up (since the end of the stress program).)
  • Changes in "The Cohen Perceived Stress Questionnaire" (PSQ) scores.(Three measures: at the beginning of the study, at three months (when the stress program is finished) and at three months follow up (since the end of the stress program).)
  • Changes in "The Stress Vulnerability Inventory" (SVI) scores.(Three measures: at the beginning of the study, at three months (when the stress program is finished) and at three months follow up (since the end of the stress program).)
  • Changes in "Penn State Worry Questionnaire" (PSWQ) scores.(Three measures: at the beginning of the study, at three months (when the stress program is finished) and at three months follow up (since the end of the stress program).)
  • Changes in "Life Orientation Test Revised" (LOT-R) scores.(Three measures: at the beginning of the study, at three months (when the stress program is finished) and at three months follow up (since the end of the stress program).)

研究者

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

María Ángeles García León

Principal Investigator

Universidad de Granada

研究点 (2)

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