Comparative Intervention Study of Stress Reduction in Corporate Health Management

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Stress, Psychological

Intervention / Treatment
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* Behavioral: HRV_Bfb
* Behavioral: MBI
* Behavioral: MBI_HRV_Bfb


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HRV-Bfb<br>HRV biofeedback, training about 30 minutes/day | Behavioral: HRV_Bfb<br> <br> |
| Experimental: MBI<br>Mindfulness based intervention, training about 30 minutes/day | Behavioral: MBI<br> <br> |
| Other: MBI_HRV-Bfb<br>Mindfulness based HRV biofeedback. Wait list control group for the interventions HRV-Bfb and MBI, after the main phase intervention with combined method. | Behavioral: MBI_HRV_Bfb<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alteration in psychological parameters of stress perception after training | 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. | 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 stress coping (behavioral skills) after training | We assessed psychological parameters of stress coping with the following questionnaire: SVF 120 (Stressverarbeitungsfragebogen; Janke & Erdmann, 1997). Alteration in data will be statistically compared. | 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 stress coping (behavior pattern) after training | 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. | 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 physiological parameters of stress: HRV parameters | 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. | 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 physiological parameters of stress: Salivary cortisol | Cortisol was assessed as salivary cortisol (one sample per subject per assessment point). Alteration in data will be statistically compared. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alteration in psychological parameters of psychological wellbeing after training | We assessed psychological wellbeing with the following questionnaire: HEALTH-49 (Kurzversion der Hamburger Module zur Erfassung allgemeiner Aspekte psychosozialer Gesundheit für die therapeutische Praxis; Rabung, Harfst, Koch & Schulz, 2007). Alteration in data will be statistically compared. | 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 | We assessed depressive symptoms with the following questionnaire: Beck Depressions-Inventar (BDI-II; Hautzinger, Keller & Kühner; 2006). Alteration in data will be statistically compared. | 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 | We assessed mindfulness with the following questionnaire: FFA 14 (Kurzversion des Freiburger Fragebogens zur Achtsamkeit; Walach et al., 2006). Alteration in data will be statistically compared. | 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 | We assessed self-compassion with the following questionnaire: SCS-D-Kurzform (Self-Compassion Scale; Hupfeld & Ruffieux, 2011). Alteration in data will be statistically compared. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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corporate health management, hrv, mindfulness