Comparative Intervention Study of Stress Reduction in Corporate Health Management

Not Applicable

Completed

• Conditions: Stress, Psychological
• Interventions: Behavioral: MBI; Behavioral: MBI_HRV_Bfb; Behavioral: HRV_Bfb

• Registration Number: NCT02709551
• Lead Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Study First Submitted: 2016-02-05
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-10
• Last Update Submitted: 2016-03-10
• Study First Posted: 2016-03-16
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MBI	MBI	Mindfulness based intervention, training about 30 minutes/day
MBI_HRV-Bfb	MBI_HRV_Bfb	Mindfulness based HRV biofeedback. Wait list control group for the interventions HRV-Bfb and MBI, after the main phase intervention with combined method.
HRV-Bfb	HRV_Bfb	HRV biofeedback, training about 30 minutes/day

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.