Clinical trial NCT02709551: Comparative Intervention Study of Stress Reduction in Corporate Health Management
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Keywords: corporate health management
hrv
mindfulness
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
Collaborators: name: Universität Tübingen
name: Harvard Medical School (HMS and HSDM)
First posted: 2016-03-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Alteration in psychological parameters of stress perception after training
timeFrame: 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)
measure: Alteration in psychological parameters of stress coping (behavioral skills) after training
timeFrame: 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)
measure: Alteration in psychological parameters of stress coping (behavior pattern) after training
timeFrame: 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)
measure: Alteration in physiological parameters of stress: HRV parameters
timeFrame: 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)
measure: Alteration in physiological parameters of stress: Salivary cortisol
timeFrame: 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)
Secondary outcomes:
measure: Alteration in psychological parameters of psychological wellbeing after training
timeFrame: 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)
measure: Alteration in psychological parameters of depression after training
timeFrame: 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)
measure: Alteration in psychological parameters of mindfulness after training
timeFrame: 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)
measure: Alteration in psychological parameters of self-compassion after training
timeFrame: 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)
Other outcomes:
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