Clinical trial NCT05828693: Systemic Stress Prevention Via Application SysLife© for Companies
Official title: Efficacy of Systemic Stress Prevention Via Application SysLife© for Companies: A Randomized Controlled Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Stress, Systemic
Application
Keywords: Stress management
Application, App
Prevention
Systemic therapy
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
Collaborators: name: Sysba solutions GmbH
name: Murtfeldt Kunststoffe GmbH & Co. KG
First posted: 2023-04-25
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline stress and coping at 4 months
timeFrame: baseline, 4-month follow-up
measure: Change from baseline chronic stress at 4 months
timeFrame: baseline, 4-month follow-up
Secondary outcomes:
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
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
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
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
measure: Frequency of application use
timeFrame: baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up
Other outcomes:
Locations:
city: Witten
country: Germany
facility: Witten/Herdecke University
state: NRW
Study officials:
affiliation: University of Witten/Herdecke
name: Christina Hunger-Schoppe, Prof. Dr.
role: STUDY_DIRECTOR
References:
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.
citation: Barth, I., Immel, N. & Hunger-Schoppe, C. (2023). Systemische Prävention. [in print, Publisher: Kohlhammer]
citation: Satow, L. (2012). Stress and Coping Inventory (SCI). available under: http://www.drsatow.de/tests/stress-und-coping-inventar/
citation: Schulz, P., Schlotz, W. & Becker, P. (2004). Trier Inventory for Chronic Stress. Göttingen: Hogrefe.
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.