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Systemic Stress Prevention Via Application SysLife© for Companies

Primary Purpose

Stress, Psychological, Stress, Systemic, Application

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
SysLife©
SysLife©, as intervention after closing the RCT-design
Sponsored by
University of Witten/Herdecke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological focused on measuring Stress management, Application, App, Prevention, Systemic therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Witten/Herdecke UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental group

Waiting group with subsequent intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

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
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)
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)
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)
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

Full Information

First Posted
December 12, 2022
Last Updated
April 12, 2023
Sponsor
University of Witten/Herdecke
Collaborators
Sysba solutions GmbH, Murtfeldt Kunststoffe GmbH & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT05828693
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 29, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Witten/Herdecke
Collaborators
Sysba solutions GmbH, Murtfeldt Kunststoffe GmbH & Co. KG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Stress, Systemic, Application
Keywords
Stress management, Application, App, Prevention, Systemic therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Use of the SysLife© application, with 2-, 4-, 6- and 8-month follow-up.
Arm Title
Waiting group with subsequent intervention
Arm Type
Other
Arm Description
Use of the SysLife© application after 4-month waiting period, with 2- and 4-month follow-up.
Intervention Type
Behavioral
Intervention Name(s)
SysLife©
Intervention Description
Use of the SysLife© application, with 2-, 4-, 6- and 8-month follow-up.
Intervention Type
Behavioral
Intervention Name(s)
SysLife©, as intervention after closing the RCT-design
Intervention Description
Use of the SysLife© application after 4-month waiting period, with 2- and 4-month follow-up.
Primary Outcome Measure Information:
Title
Change from baseline stress and coping at 4 months
Description
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
Title
Change from baseline chronic stress at 4 months
Description
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
Secondary Outcome Measure Information:
Title
Goal Attainment Scaling (GAS; Grosse Holtforth & Grawe, 2002)
Description
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
Title
Experience in Social Systems (EXIS; Hunger et al., 2017)
Description
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
Title
Stress and Coping Inventory (SCI; Satow, 2012)
Description
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
Title
Trier Inventory on Chronic Stress (TICS; Schulz, Schlotz & Becker, 2004)
Description
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
Title
Frequency of application use
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magdalena Wendt, B.Sc.
Phone
0049-2302/9267907
Email
magdalena.wendt@uni-wh.de
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Hunger-Schoppe, Prof. Dr.
Phone
0049-2302/9267907
Email
Christina.Hunger-Schoppe@uni-wh.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Hunger-Schoppe, Prof. Dr.
Organizational Affiliation
University of Witten/Herdecke
Official's Role
Study Director
Facility Information:
Facility Name
Witten/Herdecke University
City
Witten
State/Province
NRW
ZIP/Postal Code
58455
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Hunger-Schoppe, Prof. Dr.
Email
christina.hunger-schoppe@uni-wh.de

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26858173
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.
Results Reference
background
Citation
Barth, I., Immel, N. & Hunger-Schoppe, C. (2023). Systemische Prävention. [in print, Publisher: Kohlhammer]
Results Reference
background
Citation
Satow, L. (2012). Stress and Coping Inventory (SCI). available under: http://www.drsatow.de/tests/stress-und-coping-inventar/
Results Reference
background
Citation
Schulz, P., Schlotz, W. & Becker, P. (2004). Trier Inventory for Chronic Stress. Göttingen: Hogrefe.
Results Reference
background
PubMed Identifier
22471333
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.
Results Reference
background

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Systemic Stress Prevention Via Application SysLife© for Companies

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