Comparative Intervention Study of Stress Reduction in Corporate Health Management

ARCIM Institute Academic Research in Complementary and Integrative Medicine60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stress, Psychological

Interventions

HRV_BfbBEHAVIORAL

MBIBEHAVIORAL

MBI_HRV_BfbBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

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.

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.

Data from ClinicalTrials.gov

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Secondary Outcomes

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.

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.

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.

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.