Comparative Intervention Study of Stress Reduction in Corporate Health Management

Stress, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02709551
• Other study ID #: STM_04
• Status: Completed
• Phase: N/A
• First received: February 5, 2016
• Last updated: March 10, 2016
• Start date: February 2015
• Est. completion date: July 2015

Study information

• Verified date: March 2016
• Source: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress, Psychological

Intervention

Behavioral:
• HRV_Bfb

• MBI

• MBI_HRV_Bfb

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
ARCIM Institute Academic Research in Complementary and Integrative Medicine	Harvard Medical School, University of Tuebingen, Germany

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No