Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT02709551
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2016-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Intervention Study of Stress Reduction in Corporate Health Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-10', 'studyFirstSubmitDate': '2016-02-05', 'studyFirstSubmitQcDate': '2016-03-10', 'lastUpdatePostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alteration in psychological parameters of stress perception after training', 'timeFrame': '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)', '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.'}, {'measure': 'Alteration in psychological parameters of stress coping (behavioral skills) after training', 'timeFrame': '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)', '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.'}, {'measure': 'Alteration in psychological parameters of stress coping (behavior pattern) after training', 'timeFrame': '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)', '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.'}, {'measure': 'Alteration in physiological parameters of stress: HRV parameters', 'timeFrame': '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)', '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.'}, {'measure': 'Alteration in physiological parameters of stress: Salivary cortisol', 'timeFrame': '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)', 'description': 'Cortisol was assessed as salivary cortisol (one sample per subject per assessment point). Alteration in data will be statistically compared.'}], 'secondaryOutcomes': [{'measure': 'Alteration in psychological parameters of psychological wellbeing after training', 'timeFrame': '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)', '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.'}, {'measure': 'Alteration in psychological parameters of depression after training', 'timeFrame': '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)', '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.'}, {'measure': 'Alteration in psychological parameters of mindfulness after training', 'timeFrame': '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)', '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.'}, {'measure': 'Alteration in psychological parameters of self-compassion after training', 'timeFrame': '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)', '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.'}]}, 'conditionsModule': {'keywords': ['corporate health management', 'hrv', 'mindfulness'], 'conditions': ['Stress, Psychological']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults\n* Working in the business in which the study is conducted\n\nExclusion Criteria:\n\n* Cardiac disease\n* Thyroid disease (intake of glucocorticoids)\n* Actual psychological illness\n* Intake of psychotropic drugs\n* Intake of other medication changing HRV'}, 'identificationModule': {'nctId': 'NCT02709551', 'briefTitle': 'Comparative Intervention Study of Stress Reduction in Corporate Health Management', 'organization': {'class': 'OTHER', 'fullName': 'ARCIM Institute Academic Research in Complementary and Integrative Medicine'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'STM_04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HRV-Bfb', 'description': 'HRV biofeedback, training about 30 minutes/day', 'interventionNames': ['Behavioral: HRV_Bfb']}, {'type': 'EXPERIMENTAL', 'label': 'MBI', 'description': 'Mindfulness based intervention, training about 30 minutes/day', 'interventionNames': ['Behavioral: MBI']}, {'type': 'OTHER', 'label': 'MBI_HRV-Bfb', 'description': 'Mindfulness based HRV biofeedback. Wait list control group for the interventions HRV-Bfb and MBI, after the main phase intervention with combined method.', 'interventionNames': ['Behavioral: MBI_HRV_Bfb']}], 'interventions': [{'name': 'HRV_Bfb', 'type': 'BEHAVIORAL', 'armGroupLabels': ['HRV-Bfb']}, {'name': 'MBI', 'type': 'BEHAVIORAL', 'armGroupLabels': ['MBI']}, {'name': 'MBI_HRV_Bfb', 'type': 'BEHAVIORAL', 'armGroupLabels': ['MBI_HRV-Bfb']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ARCIM Institute Academic Research in Complementary and Integrative Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universität Tübingen', 'class': 'OTHER'}, {'name': 'Harvard Medical School (HMS and HSDM)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}