Comparative Intervention Study of Stress Reduction in Corporate Health Management

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

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 Overview

• Status: Completed
• Conditions: Stress, Psychological
• Intervention / Treatment: Behavioral: HRV_Bfb; Behavioral: MBI; Behavioral: MBI_HRV_Bfb

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HRV-Bfb; HRV biofeedback, training about 30 minutes/day	Behavioral: HRV_Bfb
EXPERIMENTAL: MBI; Mindfulness based intervention, training about 30 minutes/day	Behavioral: MBI
OTHER: 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.	Behavioral: MBI_HRV_Bfb

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Collaborators: Harvard Medical School (HMS and HSDM); Universität Tübingen

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (ACTUAL): July 1, 2015
• Study Completion (ACTUAL): July 1, 2015

Study Registration Dates

• First Submitted: February 5, 2016
• First Submitted That Met QC Criteria: March 10, 2016
• First Posted (ESTIMATE): March 16, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): March 16, 2016
• Last Update Submitted That Met QC Criteria: March 10, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: mindfulness; corporate health management; hrv
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: STM_04