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Comparative Intervention Study of Stress Reduction in Corporate Health Management

Primary Purpose

Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HRV_Bfb
MBI
MBI_HRV_Bfb
Sponsored by
ARCIM Institute Academic Research in Complementary and Integrative Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological focused on measuring corporate health management, hrv, mindfulness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Other

    Arm Label

    HRV-Bfb

    MBI

    MBI_HRV-Bfb

    Arm Description

    HRV biofeedback, training about 30 minutes/day

    Mindfulness based intervention, training about 30 minutes/day

    Mindfulness based HRV biofeedback. Wait list control group for the interventions HRV-Bfb and MBI, after the main phase intervention with combined method.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    February 5, 2016
    Last Updated
    March 10, 2016
    Sponsor
    ARCIM Institute Academic Research in Complementary and Integrative Medicine
    Collaborators
    Universität Tübingen, Harvard Medical School (HMS and HSDM)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02709551
    Brief Title
    Comparative Intervention Study of Stress Reduction in Corporate Health Management
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    ARCIM Institute Academic Research in Complementary and Integrative Medicine
    Collaborators
    Universität Tübingen, Harvard Medical School (HMS and HSDM)

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress, Psychological
    Keywords
    corporate health management, hrv, mindfulness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HRV-Bfb
    Arm Type
    Experimental
    Arm Description
    HRV biofeedback, training about 30 minutes/day
    Arm Title
    MBI
    Arm Type
    Experimental
    Arm Description
    Mindfulness based intervention, training about 30 minutes/day
    Arm Title
    MBI_HRV-Bfb
    Arm Type
    Other
    Arm Description
    Mindfulness based HRV biofeedback. Wait list control group for the interventions HRV-Bfb and MBI, after the main phase intervention with combined method.
    Intervention Type
    Behavioral
    Intervention Name(s)
    HRV_Bfb
    Intervention Type
    Behavioral
    Intervention Name(s)
    MBI
    Intervention Type
    Behavioral
    Intervention Name(s)
    MBI_HRV_Bfb
    Primary Outcome Measure Information:
    Title
    Alteration in psychological parameters of stress perception after training
    Description
    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)
    Title
    Alteration in psychological parameters of stress coping (behavioral skills) after training
    Description
    We assessed psychological parameters of stress coping with the following questionnaire: SVF 120 ("Stressverarbeitungsfragebogen; Janke & Erdmann, 1997). 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)
    Title
    Alteration in psychological parameters of stress coping (behavior pattern) after training
    Description
    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.
    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)
    Title
    Alteration in physiological parameters of stress: HRV parameters
    Description
    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.
    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)
    Title
    Alteration in physiological parameters of stress: Salivary cortisol
    Description
    Cortisol was assessed as salivary cortisol (one sample per subject per assessment point). 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)
    Secondary Outcome Measure Information:
    Title
    Alteration in psychological parameters of psychological wellbeing after training
    Description
    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.
    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)
    Title
    Alteration in psychological parameters of depression after training
    Description
    We assessed depressive symptoms with the following questionnaire: Beck Depressions-Inventar (BDI-II; Hautzinger, Keller & Kühner; 2006). 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)
    Title
    Alteration in psychological parameters of mindfulness after training
    Description
    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.
    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)
    Title
    Alteration in psychological parameters of self-compassion after training
    Description
    We assessed self-compassion with the following questionnaire: SCS-D-Kurzform ("Self-Compassion Scale"; Hupfeld & Ruffieux, 2011). 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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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    Comparative Intervention Study of Stress Reduction in Corporate Health Management

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