- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05828693
Systemic Stress Prevention Via Application SysLife© for Companies
Efficacy of Systemic Stress Prevention Via Application SysLife© for Companies: A Randomized Controlled Feasibility Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christina Hunger-Schoppe, Prof. Dr.
- Phone Number: 0049-2302/9267907
- Email: Christina.Hunger-Schoppe@uni-wh.de
Study Contact Backup
- Name: Magdalena Wendt, B.Sc.
- Phone Number: 0049-2302/9267907
- Email: magdalena.wendt@uni-wh.de
Study Locations
-
-
NRW
-
Witten, NRW, Germany, 58455
- Recruiting
- Witten/Herdecke University
-
Contact:
- Christina Hunger-Schoppe, Prof. Dr.
- Email: christina.hunger-schoppe@uni-wh.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
Use of the SysLife© application, with 2-, 4-, 6- and 8-month follow-up.
|
Use of the SysLife© application, with 2-, 4-, 6- and 8-month follow-up.
|
Other: Waiting group with subsequent intervention
Use of the SysLife© application after 4-month waiting period, with 2- and 4-month follow-up.
|
Use of the SysLife© application after 4-month waiting period, with 2- and 4-month follow-up.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline stress and coping at 4 months
Time Frame: baseline, 4-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, 4-month follow-up
|
Change from baseline chronic stress at 4 months
Time Frame: baseline, 4-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, 4-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Goal Attainment Scaling (GAS; Grosse Holtforth & Grawe, 2002)
Time Frame: baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up
|
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)
Time Frame: baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up
|
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)
Time Frame: baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up
|
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)
Time Frame: baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up
|
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
Time Frame: baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Christina Hunger-Schoppe, Prof. Dr., University of Witten/Herdecke
Publications and helpful links
General Publications
- 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.
- Barth, I., Immel, N. & Hunger-Schoppe, C. (2023). Systemische Prävention. [in print, Publisher: Kohlhammer]
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SysLife©
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stress, Psychological
-
New York State Psychiatric InstituteJohnson & JohnsonCompletedPsychological Stress in PregnancyUnited States
-
Baylor UniversityCompletedAcute Psychological StressUnited States
-
Örebro University, SwedenCompletedPsychological Stress Due to SkydivingSweden
-
Massachusetts General HospitalCompletedStress | Emotional Stress | Psychological Stress | Social Stress | Life StressUnited States
-
Amrita Vishwa VidyapeethamAmrita Viswa VidyapeethamCompletedCovid Related Psychological StressIndia
-
Institut de Recherche Biomedicale des ArmeesCompletedPsychological Stresses
-
University of California, San FranciscoNational Institute on Aging (NIA); Penn State University; Harvard UniversityCompletedStress | Depressive Symptoms | Psychological Distress | Psychological Stress | Signs and Symptoms | Psychological | Child MaltreatmentUnited States
-
Penn State UniversityStony Brook University; National Institute on Aging (NIA); Oregon State University and other collaboratorsCompleted
-
Military Academy at ETH ZurichSwiss Armed ForcesCompletedPsychological Stress | Psychological AdaptationSwitzerland
-
Nagoya City UniversityAichi Health Promotion FoundationCompleted
Clinical Trials on SysLife©
-
Fondation Oeuvre de la Croix Saint-SimonWithdrawnPain | Anxiety | BandageFrance
-
University of Alabama at BirminghamLakeshore FoundationWithdrawnExercise | Disability Physical
-
Queen's UniversityTerminatedLateral EpicondylitisCanada
-
Assistance Publique - Hôpitaux de ParisCompletedCuff Overinflation | Cuff UnderinflationFrance
-
Temple UniversityUnknownCritical Limb IschemiaUnited States
-
University Health Network, TorontoJewish General Hospital; Lakeridge Health Corporation; Red Deer Regional Hospital...CompletedStroke | DysphagiaCanada
-
University of Illinois at ChicagoCompletedCognitive Impairment | Sedentary Behavior
-
Pansatori GmbHCompetence Center for Medical Devices GmbHUnknown
-
University of ValenciaCompletedDental Arch Relationship Anomaly
-
Wake Forest University Health SciencesWithdrawn