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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
251
Use of the app-based digital self-help intervention harmony over a 12-week-period. The app was designed for stress management and the preventive promotion of mental health. Harmony provides users with access to a wide range of psychological self-help content, including video episodes, audio sessions, texts, and downloadable materials. Utilizing artificial intelligence, Harmony offers personalized content suggestions tailored to the user's individual situation and preferences, ensuring the content remains relevant and updated. Content is delivered through a combination of psychoeducation, guided exercises, relaxation techniques, meditations, practical tasks, self-reflection activities, and everyday application tasks.
Witten/Herdecke University
Witten, North Rhine-Westphalia, Germany
Change from baseline stress at 6 weeks and 12 months
Perceived Stress Scale (PSS-10, Cohen et al., 1983): Self-report measure to assess psychological stress levels; Likert scale: 1 = never, 5 = very often.
Time frame: Baseline, 6-week follow-up, 12-week follow-up
Change from baseline stress symptoms at 6 weeks and 12 months
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)
Time frame: Baseline, 6-week follow-up, 12-week follow-up
Subjective well-being
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.
Time frame: Baseline, 6-week follow-up, 12-week follow-up
Resilient coping
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.
Time frame: Baseline, 6-week follow-up, 12-week follow-up
Self-efficacy
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.
Time frame: Baseline, 6-week follow-up, 12-week follow-up
Life satisfaction
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.
Time frame: Baseline, 6-week follow-up, 12-week follow-up
Goal Attainment
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%
Time frame: Baseline, 6-week follow-up, 12-week follow-up
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)
Time frame: Baseline, 6-week follow-up, 12-week follow-up
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