AzTrials
AzTrials

StressNCT06744452

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

A study testing harmony in people with Stress and Self Efficacy, run by University of Witten/Herdecke at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stress, Self Efficacy, Resilience, Psychological
What is being tested?
harmony
Could I receive a placebo?
No, everyone receives an active treatment
How many people
251 participants
Where
1 siteGermany
Study dates
25 Nov 2024to 3 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Witten/Herdecke University

    Witten, North Rhine-Westphalia, 58455

Other trials in Germany

About this study

Official title: 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.

Being tested
harmony
Keywords
Stress management, Stress prevention, Application, App-based prevention
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • harmonyBehavioural

    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.

Study groups in NCT06744452
Study groupRoleWhat they receive
App-usage across a 12 week time periodExperimentalUse 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.
Receives: Behavioral: harmony
Waitlist-control groupNo interventionUse 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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)

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

Secondary outcomes (6)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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%

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

  6. 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2024
  2. Study start25 Nov 2024
  3. Primary completion3 Mar 2025
  4. Study completion3 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
251 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06744452
Sponsor's protocol ID
HARMONY RCT
Status last verified
Mar 2026
First submitted
9 Sep 2024
Last updated
24 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 31697243

Questions about this trial

What is this clinical trial studying?

A study testing harmony in people with Stress and Self Efficacy, run by University of Witten/Herdecke at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline stress at 6 weeks and 12 months (time frame: Baseline, 6-week follow-up, 12-week follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06744452, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in