Systemic Stress Prevention Via Application SysLife© for Companies

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Systemic Stress Prevention Via Application SysLife© for Companies: A Randomized Controlled Feasibility Study

Conditions
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Stress, Psychological, Stress, Systemic, Application

Intervention / Treatment
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* Behavioral: SysLife©
* Behavioral: SysLife©, as intervention after closing the RCT-design


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum age: 18 years Interest in active use of the SysLife© application Knowledge of German at native language level or the ability to use German language independently (at least B-level) Only persons capable of giving consent will be included in the study Written consent to participate after information about the study Exclusion Criteria: No written consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Use of the SysLife© application, with 2-, 4-, 6- and 8-month follow-up. | Behavioral: SysLife©<br>* Use of the SysLife© application, with 2-, 4-, 6- and 8-month follow-up.<br>|
| Other: Waiting group with subsequent intervention<br>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<br>* Use of the SysLife© application after 4-month waiting period, with 2- and 4-month follow-up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress management, Application, App, Prevention, Systemic therapy