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AzTrials

Stress, PsychologicalNCT05828693

Systemic Stress Prevention Via Application SysLife© for Companies

A study testing SysLife© and SysLife©, as intervention after closing the RCT-design in people with Stress, Psychological and Stress, Systemic, run by University of Witten/Herdecke at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SysLife© and SysLife©, as intervention after closing the RCT-design
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteGermany
Study dates
29 Jan 2023to 1 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • No written consent

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Witten/Herdecke University

    Witten, North Rhine-Westphalia, 58455

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
SysLife©, SysLife©, as intervention after closing the RCT-design
Keywords
Stress management, Application, App, Prevention, Systemic therapy
Medical subject headings
Stress, Psychological, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SysLife©Behavioural

    Use of the SysLife© application, with 2-, 4-, 6- and 8-month follow-up.

  • SysLife©, as intervention after closing the RCT-designBehavioural

    Use of the SysLife© application after 4-month waiting period, with 2- and 4-month follow-up.

Study groups in NCT05828693
Study groupRoleWhat they receive
Experimental groupExperimentalUse of the SysLife© application, with 2-, 4-, 6- and 8-month follow-up.
Receives: Behavioral: SysLife©
Waiting group with subsequent interventionOtherUse of the SysLife© application after 4-month waiting period, with 2- and 4-month follow-up.
Receives: Behavioral: SysLife©, as intervention after closing the RCT-design

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: baseline, 4-month follow-up

  2. 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)

    Measured: baseline, 4-month follow-up

Secondary outcomes (5)

  1. 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

    Measured: baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up

  2. 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)

    Measured: baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up

  3. 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)

    Measured: baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up

  4. 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)

    Measured: baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up

  5. 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

    Measured: baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2023
  2. Study start29 Jan 2023
  3. Primary completion1 Mar 2024
  4. Study completion1 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05828693
Sponsor's protocol ID
SysLife©
Status last verified
May 2024
First submitted
12 Dec 2022
Last updated
8 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 26858173

  • 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.

    PubMed 22471333

Questions about this trial

What is this clinical trial studying?

A study testing SysLife© and SysLife©, as intervention after closing the RCT-design in people with Stress, Psychological and Stress, Systemic, run by University of Witten/Herdecke at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline stress and coping at 4 months (time frame: baseline, 4-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05828693, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.

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