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

App-based Stress Management: A Pragmatic Randomized Controlled Trial on the Efficacy of 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.

Study Overview

• Status: Completed
• Conditions: Stress; Self Efficacy; Resilience, Psychological; Goal Achievement; Well-Being, Psychological
• Intervention / Treatment: Behavioral: harmony

• Study Type: Interventional
• Enrollment (Actual): 251
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • North Rhine-Westphalia
    • Witten, North Rhine-Westphalia, Germany, 58455
      • Witten/Herdecke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: App-usage across a 12 week time period; 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.	Behavioral: harmony; 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.
No Intervention: Waitlist-control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: University of Witten/Herdecke
• Investigators: Study Director: Christina Hunger-Schoppe, Prof. Dr., University of Witten/Herdecke

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2024
• Primary Completion (Actual): March 3, 2025
• Study Completion (Actual): March 3, 2025

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): December 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Application; Stress management; Stress prevention; App-based prevention
• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Psychological Well-Being; Harmony Hard
• Other Study ID Numbers: HARMONY RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No