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Completed

NCT Number: NCT06744452

App-based Stress Management With the mHealth Application "Harmony"

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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Key information

Conditions

Stress Behavior Goal Achievement Personal Satisfaction Psychological Well-Being Resilience, Psychological Self Efficacy Well-Being, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Witten/Herdecke University

Witten, North Rhine-Westphalia, 58455, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change from baseline stress at 6 weeks and 12 months

    Time frame: 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.

  2. Change from baseline stress symptoms at 6 weeks and 12 months

    Time frame: 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 outcomes

  1. Subjective well-being

    Time frame: 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.

  2. Resilient coping

    Time frame: 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.

  3. Self-efficacy

    Time frame: 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.

  4. Life satisfaction

    Time frame: 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.

  5. Goal Attainment

    Time frame: 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%

  6. Experience in Social Systems (EXIS; Hunger et al., 2017)

    Time frame: 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)

Other outcomes

  1. Frequency of application use

    Time frame: 6-week follow-up, 12-week follow-up (experiment group only)

    Participants' self report on absolut app usage over the past 6 weeks in days.

  2. Duration of application use

    Time frame: 6-week follow-up, 12-week follow-up (experiment group only)

    Participants' self report on average app usage in minutes per session.

  3. Extent of application use

    Time frame: 6-week follow-up, 12-week follow-up (experiment group only)

    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.

  4. User experience

    Time frame: 6-week follow-up, 12-week follow-up (experiment group only)

    Participants' self-report on overall impressions of the app. Likert scale from 1 = don't agree at all to 5 = completely agree

  5. User satisfaction

    Time frame: 6-week follow-up, 12-week follow-up (experiment group only)

    Participants' self report on overall satisfaction with their experience using the app. Likert scale from 1 = very bad to 5 = very good

Sponsors and collaborators

Lead sponsor

University of Witten/Herdecke

Other

Registry information

Official study title

App-based Stress Management: A Pragmatic Randomized Controlled Trial on the Efficacy of the mHealth Application "Harmony"

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 20, 2024
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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