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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| App-usage across a 12 week time period | Experimental | Use of the harmony application, with 6- and 12-week follow-up. Measurements will be taken at baseline as well as at 6- and 12-week follow-up. |
|
| Waitlist-control group | No Intervention | Use of the harmony application after a 12-week waiting period. Measurements will be taken at baseline as well as at 6- and 12-week follow-up. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| harmony | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) | Baseline, 6-week follow-up, 12-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6-week follow-up, 12-week follow-up |
| Resilient coping |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of application use | Participants' self report on absolut app usage over the past 6 weeks in days. | 6-week follow-up, 12-week follow-up (experiment group only) |
| Duration of application use | Participants' self report on average app usage in minutes per session. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Hunger-Schoppe, Prof. Dr. | University of Witten/Herdecke | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Witten/Herdecke University | Witten | North Rhine-Westphalia | 58455 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31697243 | Background | Apolinario-Hagen J, Hennemann S, Fritsche L, Druge M, Breil B. Determinant Factors of Public Acceptance of Stress Management Apps: Survey Study. JMIR Ment Health. 2019 Nov 7;6(11):e15373. doi: 10.2196/15373. |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C087247 | Harmony Hard |
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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.
| 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. | 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. | 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% | 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) | Baseline, 6-week follow-up, 12-week follow-up |
| 6-week follow-up, 12-week follow-up (experiment group only) |
| Extent of application use | Participants' self report on the extent of usage of different features within the app over the past six weeks. Respondents are asked to indicate which of the following functions they have used: Video, meditation, resilience course, texts, downloadable materials, and mental health checkup. Additionally, respondents specify the frequency of usage for each function. | 6-week follow-up, 12-week follow-up (experiment group only) |
| User experience | Participants' self-report on overall impressions of the app. Likert scale from 1 = don't agree at all to 5 = completely agree | 6-week follow-up, 12-week follow-up (experiment group only) |
| User satisfaction | Participants' self report on overall satisfaction with their experience using the app. Likert scale from 1 = very bad to 5 = very good | 6-week follow-up, 12-week follow-up (experiment group only) |