Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-29 @ 10:45 AM
Study NCT ID:
NCT05828693
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2022-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systemic Stress Prevention Via Application SysLife© for Companies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2022-12-12', 'studyFirstSubmitQcDate': '2023-04-12', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline stress and coping at 4 months', 'timeFrame': 'baseline, 4-month follow-up', 'description': 'Stress and Coping Inventory (SCI; Satow, 2012): Self-report measure to assess psychological and physical stress symptoms; Likert scale: 1 = not modified (positive), 7 = very strongly modified (negative)'}, {'measure': 'Change from baseline chronic stress at 4 months', 'timeFrame': 'baseline, 4-month follow-up', 'description': 'Trier Inventory on Chronic Stress (TICS; Schulz, Schlotz \\& Becker, 2004): Self-report measure to assess chronic stress; Likert scale: 0 = never (positive), 4 = very often (negative)'}], 'secondaryOutcomes': [{'measure': 'Goal Attainment Scaling (GAS; Grosse Holtforth & Grawe, 2002)', 'timeFrame': 'baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up', 'description': "Self-report measure to assess participants' previously set goals and their achievement; Visual analogue scale: 0% = not reached at all, 100% = fully achieved"}, {'measure': 'Experience in Social Systems (EXIS; Hunger et al., 2017)', 'timeFrame': 'baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up', 'description': 'Self-report measure to assess systemic functioning in private and organizational social systems; Likert scale: 1 = not at all (negative), 6 = fully (positive)'}, {'measure': 'Stress and Coping Inventory (SCI; Satow, 2012)', 'timeFrame': 'baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up', 'description': 'Self-report measure to assess psychological and physical stress symptoms; Likert scale: 1 = not modified (positive), 7 = very strongly modified (negative)'}, {'measure': 'Trier Inventory on Chronic Stress (TICS; Schulz, Schlotz & Becker, 2004)', 'timeFrame': 'baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up', 'description': 'Self-report measure to assess chronic stress; Likert scale: 0 = never (positive), 4 = very often (negative)'}, {'measure': 'Frequency of application use', 'timeFrame': 'baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up', 'description': 'Program registration of user frequency; 0-1/week = infrequent use; 2-3/week = moderate use; 4-5/week = frequent use; 6-7/week = very frequent use'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stress management', 'Application, App', 'Prevention', 'Systemic therapy'], 'conditions': ['Stress, Psychological', 'Stress, Systemic', 'Application']}, 'referencesModule': {'references': [{'pmid': '26858173', 'type': 'BACKGROUND', 'citation': 'Hunger C, Bornhauser A, Link L, Geigges J, Voss A, Weinhold J, Schweitzer J. The Experience in Personal Social Systems Questionnaire (EXIS.pers): Development and Psychometric Properties. Fam Process. 2017 Mar;56(1):154-170. doi: 10.1111/famp.12205. Epub 2016 Feb 8.'}, {'type': 'BACKGROUND', 'citation': 'Barth, I., Immel, N. & Hunger-Schoppe, C. (2023). Systemische Prävention. [in print, Publisher: Kohlhammer]'}, {'type': 'BACKGROUND', 'citation': 'Satow, L. (2012). Stress and Coping Inventory (SCI). available under: http://www.drsatow.de/tests/stress-und-coping-inventar/'}, {'type': 'BACKGROUND', 'citation': 'Schulz, P., Schlotz, W. & Becker, P. (2004). Trier Inventory for Chronic Stress. Göttingen: Hogrefe.'}, {'pmid': '22471333', 'type': 'BACKGROUND', 'citation': 'Grosse M, Grawe K. BERN INVENTORY OF TREATMENT GOALS: PART 1. Development and First Application of a Taxonomy of Treatment Goal Themes. Psychother Res. 2002 Mar 1;12(1):79-99. doi: 10.1080/713869618.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to investigate the efficacy of systemic stress prevention via SysLife© application in a prospective, interventive, balanced, monocentric, explanatory pilot randomized controlled trial (RCT), with participants' subjective stress experience as the primary endpoint.\n\nResearch Question: Which implementations are necessary, based on the experience from this pilot RCT, to ensure the quality of a subsequent confirmatory RCT?\n\nHypothesis: We expect improvement of participants' subjective stress experience, goal achievement, systemic functioning in private and organisational social systems while using the SysLife© application.", 'detailedDescription': 'Background: Systemic prevention serves the prophylaxis of disease and/or illness, and/or damage to health. For social subsystems such as professional teams, there however still is a lack of effective preventive or health-promoting interventions. With the Prevention Act introduced in 2015 (Social Security Code, Germany: § 20 para. 1 SGB V), prevention now has to address the social context of people\'s everyday life as well ("setting/life-world approach"). Positive changes in terms of reduced stress perception or acute exposition to stress factors are supposed to be accompanied by improved systemic, psychological and physical well-being. This RCT will investigate the efficacy of the systemic stress prevention program SysLife© application.\n\nMethods: This prospective, interventive, balanced, monocentric, explanatory pilot RCT compares an experimental group (n = 19) receiving SysLife© application with a control group (n = 19) with subsequent intervention, i.e. the SysLife@ application 4 months after the experimental group. The primary endpoint is the participants\' subjective stress experience.\n\nThe data collection encompasses 5 measurement points: t1, i.e. baseline for the experimental group; t2: 2-month follow-up; t3: 4-month follow-up for the experimental group and baseline for the control group; t4: 6-month follow-up for the experimental group and 2-month follow-up for the control group; t5: 8-month follow-up for the experimental group and 2-month follow-up for the control group).\n\nThis allows for the calculation of trends considering the potential efficacy of the SysLife© application in the RCT design on the one hand (n = 19, 2-study arm approach), and in a cumulative study (n = 38, 1-study arm approach).\n\nResearch Question: Which implementations are necessary, based on the experience from this pilot RCT, to ensure the quality of a subsequent confirmatory RCT?\n\nHypothesis: We expect improvement of participants\' subjective stress experience, goal achievement, systemic functioning in private and organisational social systems while using the SysLife© application.\n\nQuestionnaires: Stress and Coping Inventory (SCI); Trier Stress Inventory (TICS); Experience in Social Systems (EXIS), Goal Attainment Scaling (GAS). Further items: demographic data, use of additional health care interventions, user behavior and effect of the SysLife© application.\n\nDiscussion: To the best of our knowledge, this will be the first prospective, interventive, balanced, monocentric, explanatory pilot RCT comparing SysLife© application with a waiting group. For study purposes, it is a challenge to implement SysLife© application in organizational contexts such as teams: systemic prevention is an innovative health-promoting approach which is not (yet) covered by the German health insurance companies; the SysLife© application is an innovative program in digital health management with high flexibility how to approach it while being standardized in its structure; though companies are increasingly interested in health-promoting interventions for their employees, they are sparing considering the investment of time and financial resources in occupational health care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum age: 18 years\n* Interest in active use of the SysLife© application\n* Knowledge of German at native language level or the ability to use German language independently (at least B-level)\n* Only persons capable of giving consent will be included in the study\n* Written consent to participate after information about the study\n\nExclusion Criteria:\n\n* No written consent'}, 'identificationModule': {'nctId': 'NCT05828693', 'briefTitle': 'Systemic Stress Prevention Via Application SysLife© for Companies', 'organization': {'class': 'OTHER', 'fullName': 'University of Witten/Herdecke'}, 'officialTitle': 'Efficacy of Systemic Stress Prevention Via Application SysLife© for Companies: A Randomized Controlled Feasibility Study', 'orgStudyIdInfo': {'id': 'SysLife©'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Use of the SysLife© application, with 2-, 4-, 6- and 8-month follow-up.', 'interventionNames': ['Behavioral: SysLife©']}, {'type': 'OTHER', 'label': 'Waiting group with subsequent intervention', 'description': 'Use of the SysLife© application after 4-month waiting period, with 2- and 4-month follow-up.', 'interventionNames': ['Behavioral: SysLife©, as intervention after closing the RCT-design']}], 'interventions': [{'name': 'SysLife©', 'type': 'BEHAVIORAL', 'description': 'Use of the SysLife© application, with 2-, 4-, 6- and 8-month follow-up.', 'armGroupLabels': ['Experimental group']}, {'name': 'SysLife©, as intervention after closing the RCT-design', 'type': 'BEHAVIORAL', 'description': 'Use of the SysLife© application after 4-month waiting period, with 2- and 4-month follow-up.', 'armGroupLabels': ['Waiting group with subsequent intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58455', 'city': 'Witten', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Witten/Herdecke University', 'geoPoint': {'lat': 51.44362, 'lon': 7.35258}}], 'overallOfficials': [{'name': 'Christina Hunger-Schoppe, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Witten/Herdecke'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Witten/Herdecke', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sysba solutions GmbH', 'class': 'UNKNOWN'}, {'name': 'Murtfeldt Kunststoffe GmbH & Co. KG', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair for clinical psychology and psychotherapy', 'investigatorFullName': 'Christina Hunger-Schoppe', 'investigatorAffiliation': 'University of Witten/Herdecke'}}}}