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临床试验/NCT02709551
NCT02709551
已完成
不适用

Comparative Intervention Study of Stress Reduction in Corporate Health Management: Evaluation of the Effects of Heart Rate Variability (HRV) Biofeedback Training, Mindfulness Based Intervention (MBI) and Mindfulness Based HRV-biofeedback

ARCIM Institute Academic Research in Complementary and Integrative Medicine0 个研究点目标入组 60 人2015年2月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Stress, Psychological
发起方
ARCIM Institute Academic Research in Complementary and Integrative Medicine
入组人数
60
主要终点
Alteration in psychological parameters of stress perception after training
状态
已完成
最后更新
10年前

概览

简要总结

Aim of the study is the evaluation of the effects (psychological and physiological) of an hrv-biofeedback training, a mindfulness training and a combination of both training methods for stress reduction.

注册库
clinicaltrials.gov
开始日期
2015年2月
结束日期
2015年7月
最后更新
10年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
ARCIM Institute Academic Research in Complementary and Integrative Medicine
责任方
Sponsor

入排标准

入选标准

  • Healthy adults
  • Working in the business in which the study is conducted

排除标准

  • Cardiac disease
  • Thyroid disease (intake of glucocorticoids)
  • Actual psychological illness
  • Intake of psychotropic drugs
  • Intake of other medication changing HRV

结局指标

主要结局

Alteration in psychological parameters of stress perception after training

时间窗: H0: Baseline time point of assessment prior to training H1: Post training time point of assessment (6 weeks after H0) H2: Follow-up (12 weeks after H0) H3: Post training time point of assessment for former wait-list control group (18 weeks after H0)

We assessed psychological parameters of stress perception with the following questionnaire: TICS ("Trierer Inventar zum chronischen Stress"; Schulz, Schlotz \& Becker, 2004). Alteration in data will be statistically compared.

Alteration in psychological parameters of stress coping (behavioral skills) after training

时间窗: H0: Baseline time point of assessment prior to training H1: Post training time point of assessment (6 weeks after H0) H2: Follow-up (12 weeks after H0) H3: Post training time point of assessment for former wait-list control group (18 weeks after H0)

We assessed psychological parameters of stress coping with the following questionnaire: SVF 120 ("Stressverarbeitungsfragebogen; Janke \& Erdmann, 1997). Alteration in data will be statistically compared.

Alteration in psychological parameters of stress coping (behavior pattern) after training

时间窗: H0: Baseline time point of assessment prior to training H1: Post training time point of assessment (6 weeks after H0) H2: Follow-up (12 weeks after H0) H3: Post training time point of assessment for former wait-list control group (18 weeks after H0)

We assessed psychological parameters of stress coping with the following questionnaire: AVEM ("Arbeitsbezogene Verhaltens- und Erlebensmuster"; Schaarschmidt \& Fischer, 2008). Alteration in data will be statistically compared.

Alteration in physiological parameters of stress: HRV parameters

时间窗: H0: Baseline time point of assessment prior to training H1: Post training time point of assessment (6 weeks after H0) H2: Follow-up (12 weeks after H0) H3: Post training time point of assessment for former wait-list control group (18 weeks after H0)

For the physiological assessment of HRV we used the HRV-Scanner from BioSign GmbH which gathers different HRV parameters like RMSSD and pNN50. HRV was assessed before and after a stressor (Stroop Color-Word Task (based on findings by Stroop, 1935) and D2-R Concentration and Endurance test (Brickenkamp et al., 2010). Alteration in data will be statistically compared.

Alteration in physiological parameters of stress: Salivary cortisol

时间窗: H0: Baseline time point of assessment prior to training H1: Post training time point of assessment (6 weeks after H0) H2: Follow-up (12 weeks after H0) H3: Post training time point of assessment for former wait-list control group (18 weeks after H0)

Cortisol was assessed as salivary cortisol (one sample per subject per assessment point). Alteration in data will be statistically compared.

次要结局

  • Alteration in psychological parameters of psychological wellbeing after training(H0: Baseline time point of assessment prior to training H1: Post training time point of assessment (6 weeks after H0) H2: Follow-up (12 weeks after H0) H3: Post training time point of assessment for former wait-list control group (18 weeks after H0))
  • Alteration in psychological parameters of depression after training(H0: Baseline time point of assessment prior to training H1: Post training time point of assessment (6 weeks after H0) H2: Follow-up (12 weeks after H0) H3: Post training time point of assessment for former wait-list control group (18 weeks after H0))
  • Alteration in psychological parameters of mindfulness after training(H0: Baseline time point of assessment prior to training H1: Post training time point of assessment (6 weeks after H0) H2: Follow-up (12 weeks after H0) H3: Post training time point of assessment for former wait-list control group (18 weeks after H0))
  • Alteration in psychological parameters of self-compassion after training(H0: Baseline time point of assessment prior to training H1: Post training time point of assessment (6 weeks after H0) H2: Follow-up (12 weeks after H0) H3: Post training time point of assessment for former wait-list control group (18 weeks after H0))

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