Comparative Intervention Study of Stress Reduction in Corporate Health Management

NCT02709551 | Completed

• 1 other identifier: STM_04
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress, Psychological

Keywords

corporate health management; hrv; mindfulness

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (3)

HRV-Bfb

EXPERIMENTAL

HRV biofeedback, training about 30 minutes/day

Behavioral: HRV_Bfb

MBI

EXPERIMENTAL

Mindfulness based intervention, training about 30 minutes/day

Behavioral: MBI

MBI_HRV-Bfb

OTHER

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

Interventions

HRV_Bfb BEHAVIORAL

HRV-Bfb

MBI BEHAVIORAL

MBI

MBI_HRV_Bfb BEHAVIORAL

MBI_HRV-Bfb

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults
• Working in the business in which the study is conducted

You may not qualify if:

• Cardiac disease
• Thyroid disease (intake of glucocorticoids)
• Actual psychological illness
• Intake of psychotropic drugs
• Intake of other medication changing HRV

Sponsors & Collaborators

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

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: March 16, 2016
• Study Start: February 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 16, 2016

Record last verified: 2016-03