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Completed

NCT Number: NCT02709551

Comparative Intervention Study of Stress Reduction in Corporate Health Management

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.

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Key information

Conditions

Stress, Psychological Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HRV_Bfb

Behavioral

MBI

Behavioral

MBI_HRV_Bfb

Behavioral

Primary outcomes

  1. Alteration in psychological parameters of stress perception after training

    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)

    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.

  2. Alteration in psychological parameters of stress coping (behavioral skills) after training

    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)

    We assessed psychological parameters of stress coping with the following questionnaire: SVF 120 ("Stressverarbeitungsfragebogen; Janke & Erdmann, 1997). Alteration in data will be statistically compared.

  3. Alteration in psychological parameters of stress coping (behavior pattern) after training

    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)

    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.

  4. Alteration in physiological parameters of stress: HRV parameters

    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)

    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.

  5. Alteration in physiological parameters of stress: Salivary cortisol

    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)

    Cortisol was assessed as salivary cortisol (one sample per subject per assessment point). Alteration in data will be statistically compared.

Secondary outcomes

  1. Alteration in psychological parameters of psychological wellbeing after training

    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)

    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.

  2. Alteration in psychological parameters of depression after training

    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)

    We assessed depressive symptoms with the following questionnaire: Beck Depressions-Inventar (BDI-II; Hautzinger, Keller & Kühner; 2006). Alteration in data will be statistically compared.

  3. Alteration in psychological parameters of mindfulness after training

    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)

    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.

  4. Alteration in psychological parameters of self-compassion after training

    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)

    We assessed self-compassion with the following questionnaire: SCS-D-Kurzform ("Self-Compassion Scale"; Hupfeld & Ruffieux, 2011). Alteration in data will be statistically compared.

Sponsors and collaborators

Lead sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Other

Collaborators

  • Harvard Medical School (HMS and HSDM)
  • Universität Tübingen

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 16, 2016
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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