Systemic Stress Prevention Via Application SysLife© for Companies

NCT05828693 | Completed DMC

• 1 other identifier: SysLife©
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Psychological; Stress, Systemic; Application

Keywords

Stress management; Application, App; Prevention; Systemic therapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Goal Attainment Scaling (GAS; Grosse Holtforth & Grawe, 2002)

  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)

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

• Stress and Coping Inventory (SCI; Satow, 2012)

  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)

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

• Frequency of application use

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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Behavioral: SysLife©

Waiting group with subsequent intervention

OTHER

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

Behavioral: SysLife©, as intervention after closing the RCT-design

Interventions

SysLife© BEHAVIORAL

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

Experimental group

SysLife©, as intervention after closing the RCT-design BEHAVIORAL

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

Waiting group with subsequent intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• No written consent

Sponsors & Collaborators

• University of Witten/Herdecke: lead
• Sysba solutions GmbH: collaborator
• Murtfeldt Kunststoffe GmbH & Co. KG: collaborator

Study Sites (1)

Witten/Herdecke University

Witten, North Rhine-Westphalia, 58455, Germany

Location

Related Publications (5)

• 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.

  PMID: 26858173 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 22471333 BACKGROUND

MeSH Terms

Conditions

Stress, Psychological; Alzheimer Disease

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Christina Hunger-Schoppe, Prof. Dr.

  University of Witten/Herdecke

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair for clinical psychology and psychotherapy

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: April 25, 2023
• Study Start: January 29, 2023
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)