Stress, Psychological
Conditions
Keywords
corporate health management, hrv, mindfulness
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.
Interventions
BEHAVIORALHRV_Bfb
BEHAVIORALMBI
BEHAVIORALMBI_HRV_Bfb
Sponsors
Universität Tübingen
Harvard Medical School (HMS and HSDM)
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alteration in physiological parameters of stress: Salivary cortisol | 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. |
| Alteration in psychological parameters of stress perception 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) | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | We assessed depressive symptoms with the following questionnaire: Beck Depressions-Inventar (BDI-II; Hautzinger, Keller & Kühner; 2006). Alteration in data will be statistically compared. |
| 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) | 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. |
| 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) | We assessed self-compassion with the following questionnaire: SCS-D-Kurzform (Self-Compassion Scale; Hupfeld & Ruffieux, 2011). Alteration in data will be statistically compared. |
| 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) | 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. |
Outcome results
None listed