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| Name | Class |
|---|---|
| Sysba solutions GmbH | UNKNOWN |
| Murtfeldt Kunststoffe GmbH & Co. KG | UNKNOWN |
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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.
Research Question: Which implementations are necessary, based on the experience from this pilot RCT, to ensure the quality of a subsequent confirmatory RCT?
Hypothesis: We expect improvement of participants' subjective stress experience, goal achievement, systemic functioning in private and organisational social systems while using the SysLife© application.
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.
Methods: 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.
The 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).
This 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).
Research Question: Which implementations are necessary, based on the experience from this pilot RCT, to ensure the quality of a subsequent confirmatory RCT?
Hypothesis: We expect improvement of participants' subjective stress experience, goal achievement, systemic functioning in private and organisational social systems while using the SysLife© application.
Questionnaires: 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.
Discussion: 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Use of the SysLife© application, with 2-, 4-, 6- and 8-month follow-up. |
|
| Waiting group with subsequent intervention | Other | Use of the SysLife© application after 4-month waiting period, with 2- and 4-month follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SysLife© | Behavioral | Use of the SysLife© application, with 2-, 4-, 6- and 8-month follow-up. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline stress and coping at 4 months | 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) | baseline, 4-month follow-up |
| Change from baseline chronic stress at 4 months | 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) | baseline, 4-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Goal Attainment Scaling (GAS; Grosse Holtforth & Grawe, 2002) | Self-report measure to assess participants' previously set goals and their achievement; Visual analogue scale: 0% = not reached at all, 100% = fully achieved | baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Hunger-Schoppe, Prof. Dr. | University of Witten/Herdecke | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Witten/Herdecke University | Witten | North Rhine-Westphalia | 58455 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26858173 | Background | 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. | |
| Background | Barth, I., Immel, N. & Hunger-Schoppe, C. (2023). Systemische Prävention. [in print, Publisher: Kohlhammer] | ||
| Background | Satow, L. (2012). Stress and Coping Inventory (SCI). available under: http://www.drsatow.de/tests/stress-und-coping-inventar/ | ||
| Background | Schulz, P., Schlotz, W. & Becker, P. (2004). Trier Inventory for Chronic Stress. Göttingen: Hogrefe. | ||
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003704 | Dementia |
| D001927 | Brain Diseases |
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| SysLife©, as intervention after closing the RCT-design | Behavioral | Use of the SysLife© application after 4-month waiting period, with 2- and 4-month follow-up. |
|
| Experience in Social Systems (EXIS; Hunger et al., 2017) |
Self-report measure to assess systemic functioning in private and organizational social systems; Likert scale: 1 = not at all (negative), 6 = fully (positive) |
| baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up |
| 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) | baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up |
| 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) | baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up |
| Frequency of application use | 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 | baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up |
| 22471333 |
| Background |
| 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. |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |