Stress, Self Efficacy, Resilience, Psychological, Goal Achievement, Well-Being, Psychological
Conditions
Keywords
Stress management, Stress prevention, Application, App-based prevention
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.
Interventions
BEHAVIORALharmony
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.
Sponsors
University of Witten/Herdecke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
* Inclusion criteria not met.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Germany
Contacts
STUDY_DIRECTORChristina Hunger-Schoppe, Prof. Dr.
University of Witten/Herdecke
Outcome results
None listed