Systemic Stress Prevention Via Application SysLife© for Companies

Stress, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05828693
• Other study ID #: SysLife©
• Status: Completed
• Phase: N/A
• Start date: January 29, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2024
• Source: University of Witten/Herdecke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stress, Psychological

Intervention

Behavioral:
• SysLife©
Use of the SysLife© application, with 2-, 4-, 6- and 8-month follow-up.
• SysLife©, as intervention after closing the RCT-design
Use of the SysLife© application after 4-month waiting period, with 2- and 4-month follow-up.

Locations

Country	Name	City	State
Germany	Witten/Herdecke University	Witten	NRW

Sponsors (3)

Lead Sponsor	Collaborator
University of Witten/Herdecke	Murtfeldt Kunststoffe GmbH & Co. KG, Sysba solutions GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (5)

Barth, I., Immel, N. & Hunger-Schoppe, C. (2023). Systemische Prävention. [in print, Publisher: Kohlhammer]

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. — View 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. — View Citation

Satow, L. (2012). Stress and Coping Inventory (SCI). available under: http://www.drsatow.de/tests/stress-und-coping-inventar/

Schulz, P., Schlotz, W. & Becker, P. (2004). Trier Inventory for Chronic Stress. Göttingen: Hogrefe.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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