An interventional study of SysLife© and SysLife©, as intervention after closing the RCT-design in Stress, Psychological, Stress, Systemic and Application, sponsored by University of Witten/Herdecke. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by University of Witten/Herdecke · Not applicable, Interventional, and Treatment
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.
806 studies on the registry are indexed under Stress, Psychological; 131 are open to participants now.
This study's enrollment of 49 is below the median of 84 across 651 interventional studies indexed under Stress, Psychological.
Browse Stress, Psychological studies →University of Witten/Herdecke is the lead sponsor of 40 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Use of the SysLife© application, with 2-, 4-, 6- and 8-month follow-up.
Behavioral: SysLife©
Use of the SysLife© application after 4-month waiting period, with 2- and 4-month follow-up.
Behavioral: SysLife©, as intervention after closing the RCT-design
Use of the SysLife© application, with 2-, 4-, 6- and 8-month follow-up.
Use of the SysLife© application after 4-month waiting period, with 2- and 4-month follow-up.
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)
Time frame: 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)
Time frame: baseline, 4-month follow-up
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
Time frame: baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up
Plan to share: No
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University of Witten/Herdecke