App-based Stress Management with the MHealth Application "harmony"

Not Applicable

Not yet recruiting

• Conditions: Stress; Self Efficacy; Resilience, Psychological; Goal Achievement; Well-Being, Psychological

• Registration Number: NCT06744452
• Lead Sponsor: University of Witten/Herdecke

Brief Summary

The purpose of this study is to investigate the efficacy of app-based stress prevention via the harmony application in a prospective, interventive, monocentric, explanatory pilot randomized controlled trial (RCT), with participants' subjective stress experience as the primary endpoint.

Research question: Does usage of the app harmony have a positive impact on the subjective experience of stress of its users? Do usage frequency, intensity or width of content engagement influence the efficacy of the intervention?

Hypothesis: We expect improvement of participants' subjective stress experience, stress-related symptoms, subjective well-being, resilient coping, self-efficacy, life satisfaction and goal-attainment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-09
• Status Verified: 2024-12
• Study Start: 2024-12-16
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-02-21
• Study Completion: 2025-02-21

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• Increased stress level (PSS-10 >= 19; corresponds to one standard deviation (SD 6.42)) above the mean (PSS-10 = 12.57) in a representative sample of the German population (Klein et al., 2016)
• Fulfillment of technical minimum requirements (internet and smartphone access with suitable operating systems)
• German language skills at a native level or the ability to use the language at at least B level
• Written informed consent to participate in the study after being informed about the study

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Exclusion Criteria

• Inclusion criteria not met.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline stress at 6 weeks and 12 months	Baseline, 6-week follow-up, 12-week follow-up	Perceived Stress Scale (PSS-10, Cohen et al., 1983): Self-report measure to assess psychological stress levels; Likert scale: 1 = never, 5 = very often.
Change from baseline stress symptoms at 6 weeks and 12 months	Baseline, 6-week follow-up, 12-week follow-up	Stress and Coping Inventory (SCI; Satow, 2024): Self-report measure to assess psychological and physical stress symptoms; Likert scale: 1 = completely true (negative), 4 = not true at all (positive)

Secondary Outcome Measures

Name	Time	Method
Subjective well-being	Baseline, 6-week follow-up, 12-week follow-up	WHO-5 Well-Being Index (WHO-5; WHO, 1998): Self-report measure to assess subjective well-being. Likert scale from 0 = at no time to 5 = all of the time.
Resilient coping	Baseline, 6-week follow-up, 12-week follow-up	Brief resilient coping scale (BRCS; Kocalevent et al., 2014): Self-report measure to assess an individual's ability to cope with stress in a resilient manner. Likert scale from 1 = describes me not at all to 5 = describes me very well.
Self-efficacy	Baseline, 6-week follow-up, 12-week follow-up	General Self-Efficacy Scale (GSE-SI; Di et al., 2023): One-item self-report measure to assess an individual's belief in their ability to perform tasks and handle situations effectively across a variety of contexts.
Life satisfaction	Baseline, 6-week follow-up, 12-week follow-up	Life Satisfaction Scale (L-1; Beierlein et al., 2015): One-item self-report measure to assess a person's subjective evaluation of their quality of life. Likert scale from 1 = not satisfied at all to 11 = completely satisfied.
Goal Attainment	Baseline, 6-week follow-up, 12-week follow-up	Goal Attainment Scaling (GAS; Grosse Holtforth \& Grawe, 2002): Self-report measure to assess participants' previously set goals and their achievement; Scale from 0% to 100% in steps of 10%
Experience in Social Systems (EXIS; Hunger et al., 2017)	Baseline, 6-week follow-up, 12-week 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)

Trial Locations

Locations (1)

Witten/Herdecke University; 🇩🇪 Witten, North Rhine-Westphalia, Germany