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

NCT06744452 | Completed DMC

• 1 other identifier: HARMONY RCT
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Self Efficacy; Resilience, Psychological; Goal Achievement; Well-Being, Psychological

Keywords

Stress management; Stress prevention; Application; App-based prevention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Subjective well-being

  Baseline, 6-week follow-up, 12-week follow-up

• Resilient coping

  Baseline, 6-week follow-up, 12-week follow-up

• Self-efficacy

  Baseline, 6-week follow-up, 12-week follow-up

• Life satisfaction

  Baseline, 6-week follow-up, 12-week follow-up

• Goal Attainment

  Baseline, 6-week follow-up, 12-week follow-up

Other Outcomes (5)

• Frequency of application use

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

• Duration of application use

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

• Extent of application use

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

Study Arms (2)

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.

Behavioral: harmony

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.

Interventions

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.

App-usage across a 12 week time period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Witten/Herdecke: lead

Study Sites (1)

Witten/Herdecke University

Witten, North Rhine-Westphalia, 58455, Germany

Location

Related Publications (1)

• 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.

  PMID: 31697243 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Harmony Hard

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Christina Hunger-Schoppe, Prof. Dr.

  University of Witten/Herdecke

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: December 20, 2024
• Study Start: November 25, 2024
• Primary Completion: March 3, 2025
• Study Completion: March 3, 2025
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)